Medical Devices; Exemptions From Premarket Notification: Class II Devices, 31976-32002 [2017-14453]

Download as PDF 31976 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices human tests to begin became effective on March 10, 1997. However, FDA records indicate that the IDE was determined substantially complete for clinical studies to have begun on March 5, 1997, which represents the IDE effective date. 2. The date an application was initially submitted with respect to the biological device under section 515 of the FD&C Act (21 U.S.C. 360e): November 29, 2013. The applicant claims December 23, 2013, as the date the premarket approval application (PMA) for INTERCEPT BLOOD SYSTEM FOR PLASMA (PMA BP130076) was initially submitted. However, FDA records indicate that the complete PMA BP130076 was submitted on November 29, 2013. 3. The date the application was approved: December 16, 2014. FDA has verified the applicant’s claim that PMA BP130076 was approved on December 16, 2014. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,860 days or 5 years of patent term extension. mstockstill on DSK30JT082PROD with NOTICES III. Petitions Food and Drug Administration [Docket No. FDA–2017–N–1129] Medical Devices; Exemptions From Premarket Notification: Class II Devices AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing a list of class II devices that the Agency has determined based on established factors to no longer require premarket notification to provide reasonable assurance of safety and effectiveness, subject to certain limitations. FDA is publishing this notice of that determination in accordance with procedures established by the 21st Century Cures Act. This notice represents FDA’s final determination with respect to the list of class II devices proposed in a March 14, 2017, Federal Register document. The exemptions in this notice will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. SUMMARY: FOR FURTHER INFORMATION CONTACT: Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in 21 CFR 60.30, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (see ADDRESSES). Dated: July 5, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–14454 Filed 7–10–17; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 DEPARTMENT OF HEALTH AND HUMAN SERVICES 18:01 Jul 10, 2017 Jkt 241001 Bryce Bennett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, email: Gregory.Bennett@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of March 14, 2017 (82 FR 13609), FDA issued a notice proposing to exempt a list of class II devices from the premarket notification requirements under section 510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)), subject to certain limitations. This notice was issued in accordance with the 21st Century Cures Act (Pub. L. 114– 255), which was signed into law on December 13, 2016. Section 3054 of that statute amended section 510(m) of the FD&C Act. As amended, section 510(m)(1)(A) of the FD&C Act provides that, within 90 days after enactment of the 21st Century Cures Act and at least once every 5 years thereafter, FDA must publish in the Federal Register a notice containing a list of each type of class II device that FDA determines no longer requires a report under section 510(k) of PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 the FD&C Act (generally referred to as a premarket notification or ‘‘510(k)’’) to provide reasonable assurance of safety and effectiveness. Within 210 days of enactment of the 21st Century Cures Act, FDA must publish in the Federal Register a list representing its final determination regarding the list of devices proposed in the March 14, 2017, notice. Section 510(m)(3) of the FD&C Act provides that upon the date that this final list is published in the Federal Register, a 510(k) will no longer be required for the listed devices and the applicable classification regulation for these devices shall be deemed amended to incorporate such exemption. Interested persons were given until May 15, 2017, to comment on the proposed list of class II devices. After reviewing these comments and considering whether the proposed list should be modified, FDA is now identifying its final determination as to which of those devices are now exempt from premarket notification requirements, subject to certain limitations, as indicated in tables 1 to 3 of this notice. In a future action, FDA intends to amend the codified language for each listed device’s classification regulation to reflect this final determination. Persons with pending 510(k) submissions for devices that are now exempt from premarket notification, subject to the limitations on exemptions, should withdraw their submissions. These exemptions will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulation. Specifically, regulated industry will no longer have to invest time and resources in premarket notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review. II. Criteria for Exemption There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the January 21, 1998, Federal Register notice (63 FR 3142) and subsequently in the guidance the Agency issued on February 19, 1998, entitled ‘‘Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff’’ (‘‘Class II 510(k) Exemption Guidance’’) (Ref. 1). E:\FR\FM\11JYN1.SGM 11JYN1 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices III. Limitations on Exemptions FDA believes that the types of class II devices listed in this notice should be exempt from the premarket notification requirements found under section 510(k) of the FD&C Act. However, an exemption from the requirement of premarket notification does not mean that the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation. FDA’s determination that premarket notification is unnecessary to provide a reasonable assurance of safety and effectiveness for devices listed in this document is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide. In addition to being subject to the general limitations to the exemptions found in Title 21 of the Code of Federal Regulations (CFR) sections 862.9 to 892.9 (§§ 862.9 to 892.9), when Agency assessment determines that the factors laid out in the Class II 510(k) Exemption Guidance (Ref. 1) do not weigh in favor of exemption for all devices in a particular group, FDA may partially limit the exemption from premarket notification requirements to specific devices within a listed device type. In such situations where a partial exemption limitation has been identified, FDA has determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices. Partial exemption limitations can be found in table 2 of this notice. FDA has assigned new product codes to the device types that are now exempt subject to the partial limitations in order to ensure that these devices can be separated from devices that do not fall within the partial exemption limitation under the existing product code (i.e., exempt and non-exempt devices within a device type will have distinct product codes). If table 2 indicates that a partial exemption limitation does apply to a device, then affected device manufacturers should review their registration and listing information to assess if they should list their device using the original classification product code, which requires premarket notification, or the new classification product code for the subset of that device type that is now 510(k) exempt (subject to the general limitations to the 31977 exemptions found in §§ 862.9 to 892.9). In table 2, for example, FDA is listing the exemption of the tympanometer but limits the exemption to such devices that are in compliance with FDArecognized consensus standard ANSI S3.39. Tympanometers that comply with this partial exemption limitation and the corresponding general limitations in § 874.9 are now exempt from the 510(k) requirements and should be identified under new product code ‘‘PTP’’ in subsequent registration and listing submissions. However, tympanometers not in compliance with each of these exemption limitations remain subject to the 510(k) requirements and will retain product code ‘‘NAS.’’ We recommend that device manufacturers document in their records any changes in the product code of their device with appropriate justification. IV. List of Class II Devices In table 1, FDA is identifying the following list of class II devices that no longer require premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in §§ 862.9 to 892.9: TABLE 1—CLASS II DEVICES mstockstill on DSK30JT082PROD with NOTICES 21 CFR section 862.1020 862.1020 862.1020 862.1020 862.1020 862.1020 862.1020 862.1090 862.1100 862.1100 862.1100 862.1100 862.1150 862.1150 862.1150 862.1150 862.1345 862.1350 862.1445 862.1445 862.1445 862.1509 862.1685 862.1700 862.1700 862.2265 862.2570 862.2570 862.2570 862.2570 862.2570 862.2570 862.2570 862.3200 862.3200 ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... VerDate Sep<11>2014 Product code Device type Acid Phosphatase, Nitrophenylphosphate ................................................................................................................... Acid Phosphatase, Thymol Blue Monophosphate ....................................................................................................... Acid Phosphatase, Disodium Phenylphosphate .......................................................................................................... Acid Phosphatase, Naphthyl Phosphate ..................................................................................................................... Acid Phosphatase, Thymolphthale Inmonophosphate ................................................................................................ Acid Phosphatase, Beta Glycerophosphate ................................................................................................................ Acid Phosphatase (Prostatic), Tartrate Inhibited ......................................................................................................... Radioassay, Angiotensin Converting Enzyme ............................................................................................................. Vanillin Pyruvate, AST/SGOT ...................................................................................................................................... Diazo, AST/SGOT ....................................................................................................................................................... Hydrazone Colorimetry, AST/SGOT ............................................................................................................................ NADH Oxidation/NAD Reduction, AST/SGOT ............................................................................................................ Calibrator, Primary ....................................................................................................................................................... Calibrator, Secondary .................................................................................................................................................. Calibrator, Surrogate ................................................................................................................................................... Calibrator, Multi-Analyte Mixture .................................................................................................................................. Drink, Glucose Tolerance ............................................................................................................................................ Continuous Glucose Monitor Secondary Display ........................................................................................................ Chromatographic Separation, Lactate Dehydrogenase Isoenzymes .......................................................................... Electrophoretic, Lactate Dehydrogenase Isoenzymes ................................................................................................ Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes ..................................................................... System, Test, Urinary Methylmalonic Acid .................................................................................................................. Radioimmunoassay, Thyroxine-Binding Globulin ........................................................................................................ Radioimmunoassay, Total Thyroxine .......................................................................................................................... Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine ...................................................................................... High Throughput DNA Sequence Analyzer ................................................................................................................. Instrumentation For Clinical Multiplex Test Systems .................................................................................................. Real Time Nucleic Acid Amplification System ............................................................................................................. Mass Spectrometer For Clinical Multiplex Test Systems ............................................................................................ Micro Total Analysis Instrument System ..................................................................................................................... Complete Gene Expression Profiling Accessory Reagents ........................................................................................ DNA Genetic Analyzer ................................................................................................................................................. Data Acquisition Software ........................................................................................................................................... Calibrators, Drug Mixture ............................................................................................................................................. Calibrators, Drug Specific ............................................................................................................................................ 18:01 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\11JYN1.SGM 11JYN1 CJN CJR CJX CKB CKE CKH JFH KQN CIF CIQ CIS CIT JIS JIT JIW JIX MRV PJT CEX CFE JGF LPT CEE CDX KLI PFF NSU OOI OTA OUE OVA PCA PQQ DKB DLJ 31978 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices TABLE 1—CLASS II DEVICES—Continued mstockstill on DSK30JT082PROD with NOTICES 21 CFR section 862.3200 864.5400 864.5400 864.5425 864.5425 864.5425 864.6550 864.6650 864.7275 864.7300 864.7340 864.7340 864.7375 864.7375 864.7375 864.7415 864.7455 864.7500 864.7720 864.7735 864.8150 864.8165 864.8175 864.8185 864.8625 864.8625 864.8625 864.8625 864.8625 864.8625 864.8625 864.8625 864.8625 864.8625 864.8625 864.9400 866.3395 866.5210 866.5210 866.5210 866.5210 866.5210 866.5210 866.5470 866.5620 866.5620 866.5620 866.5630 866.5910 868.1040 868.1400 868.2500 868.2500 868.2550 868.5180 868.6250 870.1390 870.1875 870.2675 870.4280 870.4290 870.4340 870.4420 870.4430 872.1720 872.3260 872.3300 872.3540 872.3540 872.3560 872.3590 ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... VerDate Sep<11>2014 Product code Device type Calibrators, Ethyl Alcohol ............................................................................................................................................ Fibrometer .................................................................................................................................................................... Timer, Coagulation ...................................................................................................................................................... Control, Plasma, Abnormal .......................................................................................................................................... Plasma, Coagulation Control ....................................................................................................................................... Plasma, Control, Normal ............................................................................................................................................. Control, Fecal Occult Blood ......................................................................................................................................... Study, Platelet Adhesive .............................................................................................................................................. Test, Euglobulin Lysis .................................................................................................................................................. Fibrin Monomer Paracoagulation ................................................................................................................................ Fibrinogen Standard .................................................................................................................................................... Plasma, Fibrinogen Control ......................................................................................................................................... Glutathione, Red-Cell .................................................................................................................................................. Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase ................................................................... Assay, Glutathione Reductase .................................................................................................................................... Control, Hemoglobin, Abnormal ................................................................................................................................... Stain, Fetal Hemoglobin .............................................................................................................................................. Acid Hematin ............................................................................................................................................................... Test, Prothrombin Consumption .................................................................................................................................. Prothrombin-Proconvertin and Thrombotest ................................................................................................................ Calibrator for Cell Indices ............................................................................................................................................ Calibrator for Hemoglobin and Hematocrit Measurement ........................................................................................... Calibrator for Platelet Counting ................................................................................................................................... Calibrator for Red-Cell and White-Cell Counting ........................................................................................................ Standards and Controls, Hemoglobin, Normal and Abnormal .................................................................................... Control, White-Cell ....................................................................................................................................................... Control, Hemoglobin .................................................................................................................................................... Control, Platelet ........................................................................................................................................................... Control, Red-Cell ......................................................................................................................................................... Control, Hematocrit ...................................................................................................................................................... Mixture, Control, White-Cell and Red-Cell Indices ...................................................................................................... Control, Cell Counter, Normal and Abnormal .............................................................................................................. Mixture, Hematology Quality Control ........................................................................................................................... Material, Quality Control, Semen Analysis .................................................................................................................. Control Material, Blood Circulating Epithelial Cancer Cell .......................................................................................... Solution, Stabilized Enzyme ........................................................................................................................................ Norovirus Serological Reagents .................................................................................................................................. Immunochemical, Ceruloplasmin ................................................................................................................................. Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control ........................................................................................... Ceruloplasmin, FITC, Antigen, Antiserum, Control ..................................................................................................... Ceruloplasmin, Antigen, Antiserum, Control ................................................................................................................ P-Phenyl-Enediamine/EDTA (Spectrophotometric), Ceruloplasmin ............................................................................ Indirect Copper Assay, Ceruloplasmin ........................................................................................................................ Hemoglobin, Chain Specific, Antigen, Antiserum, Control .......................................................................................... Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control .............................................................................. Alpha-2-Macroglobulin, FITC, Antigen, Antiserum, Control ........................................................................................ Alpha-2-Macroglobulin, Antigen, Antiserum, Control ................................................................................................... System, Test, Beta-2-Microglobulin Immunological .................................................................................................... Quality Control Material, Genetics, DNA ..................................................................................................................... Algesimeter, Powered .................................................................................................................................................. Legging, Compression, Non-Inflatable ........................................................................................................................ Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia ......................................................................... Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia ..................................... Pneumotachometer ...................................................................................................................................................... Bed, Rocking, Breathing Assist ................................................................................................................................... Compressor, Air, Portable ........................................................................................................................................... Trocar ........................................................................................................................................................................... Lung Sound Monitor .................................................................................................................................................... Oscillometer ................................................................................................................................................................. Filter, Prebypass, Cardiopulmonary Bypass ............................................................................................................... Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass ................................................................................. Monitor and/or Control, Level Sensing, Cardiopulmonary Bypass ............................................................................. Sucker, Cardiotomy Return, Cardiopulmonary Bypass ............................................................................................... Suction Control, Intracardiac, Cardiopulmonary Bypass ............................................................................................. Tester, Pulp ................................................................................................................................................................. External Cleaning Solution .......................................................................................................................................... Coating, Denture Hydrophilic, Resin ........................................................................................................................... Pad, Denture, Over The Counter ................................................................................................................................ Cushion, Denture, Over The Counter ......................................................................................................................... Reliner, Denture, Over The Counter ........................................................................................................................... Denture, Plastic, Tooth ................................................................................................................................................ 18:01 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\11JYN1.SGM 11JYN1 DNN GIE JBT GGC GGN GIZ OSL JBZ JBO JBN GFX GIL GII JMH KQF JCM GHQ GGF GGQ JPF KRX KRZ KRY KSA GFS GGL GGM GJP GJR GLK GLQ JCN JPK NRF NRS KSK OUC CHN DCT DCY DDB JFQ JFR DAM DDT DDY DEB JZG NZB BSI LLK KLK LPP JAX CCO BTI DRC OCR DRZ KRJ DTL DTW DTS DWD EAT PME EBE EHR EHS EBP ELM Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices 31979 TABLE 1—CLASS II DEVICES—Continued mstockstill on DSK30JT082PROD with NOTICES 21 CFR section 872.3600 872.3890 872.5550 872.6770 874.1120 874.1325 874.3310 874.3320 874.3320 874.3330 874.3430 874.3730 876.1500 876.1500 876.1500 876.1500 876.1500 876.1500 876.1500 876.1500 876.4020 876.4270 876.4400 876.4400 876.4500 876.4770 876.5010 876.5025 876.5365 876.5365 876.5365 876.5520 876.5665 876.5820 876.5895 876.5980 876.5980 878.4370 878.4370 878.4370 878.4370 878.4370 878.4370 878.4370 878.4580 878.4580 878.4580 878.4580 878.4580 878.4580 878.4580 878.4580 878.4580 878.4580 878.4580 878.5070 878.5070 878.5070 880.5580 880.5580 880.5780 882.1020 882.1540 882.1560 882.1855 882.5895 884.2990 884.3200 884.4400 884.4530 884.4530 ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... VerDate Sep<11>2014 Product code Device type Denture Preformed (Partially Prefabricated Denture) ................................................................................................. Splint, Endodontic Stabilizing ...................................................................................................................................... Ring, Teething, Fluid-Filled .......................................................................................................................................... Syringe, Cartridge ........................................................................................................................................................ Generator, Electronic Noise (for Audiometric Testing) ................................................................................................ Electroglottograph ........................................................................................................................................................ Calibrator, Hearing Aid/Earphone and Analysis Systems ........................................................................................... Hearing Aid, Group and Auditory Trainer .................................................................................................................... Device, Assistive Listening .......................................................................................................................................... Hearing Aid, Master ..................................................................................................................................................... Mold, Middle-Ear .......................................................................................................................................................... Device, Voice Amplification ......................................................................................................................................... Light Source, Incandescent, Diagnostic ...................................................................................................................... Light Source, Photographic, Fiberoptic ....................................................................................................................... Light Source, Fiberoptic, Routine ................................................................................................................................ Carrier, Sponge, Endoscopic ....................................................................................................................................... Light Source, Endoscope, Xenon Arc ......................................................................................................................... Transformer, Endoscope ............................................................................................................................................. LED Light Source ........................................................................................................................................................ Endoscopic Guide Wire, Gastroenterology-Urology .................................................................................................... Light, Catheter, Fiberoptic, Glass, Ureteral ................................................................................................................. Rod, Colostomy ........................................................................................................................................................... Ligator, Hemorrhoidal .................................................................................................................................................. Ligator, Esophageal ..................................................................................................................................................... Lithotriptor, Biliary Mechanical ..................................................................................................................................... Urethrotome ................................................................................................................................................................. Bag, Bile Collecting ..................................................................................................................................................... Vibrator for Climax Control of Premature Ejaculation ................................................................................................. Dilator, Esophageal (Metal Olive) Gastro-Urology ...................................................................................................... Bougie, Esophageal, and Gastrointestinal, Gastro-Urology ........................................................................................ Dilator, Esophageal ..................................................................................................................................................... Dilator, Urethral ............................................................................................................................................................ Disinfectant, Subsystem, Water Purification ................................................................................................................ Set, Dialyzer Holder ..................................................................................................................................................... Irrigator, Ostomy .......................................................................................................................................................... Catheter, Retention, Barium Enema With Bag ............................................................................................................ Gastrostomy Tube Holder ........................................................................................................................................... Drape, Surgical, ENT ................................................................................................................................................... Drape, Pure Latex Sheet, With Self-Retaining Finger Cot .......................................................................................... Drape, Urological, Disposable ..................................................................................................................................... Pad, Kelly ..................................................................................................................................................................... Drape, Patient, Ophthalmic ......................................................................................................................................... Drape, Microscope, Ophthalmic .................................................................................................................................. Ring (Wound Protector), Drape Retention, Internal .................................................................................................... Lamp, Operating-Room ............................................................................................................................................... Light, Surgical, Instrument ........................................................................................................................................... Light, Surgical, Floor Standing .................................................................................................................................... Light, Surgical, Endoscopic ......................................................................................................................................... Light, Surgical, Connector ........................................................................................................................................... Light, Surgical, Ceiling Mounted .................................................................................................................................. Light, Surgical, Carrier ................................................................................................................................................. Light, Surgical, Accessories ........................................................................................................................................ Lamp, Surgical ............................................................................................................................................................. Illuminator, Remote ...................................................................................................................................................... Lamp, Surgical, Incandescent ..................................................................................................................................... Apparatus, Air Handling, Bench .................................................................................................................................. Apparatus, Air Handling, Room ................................................................................................................................... Apparatus, Air Handling, Enclosure ............................................................................................................................. Locator, Acupuncture Point ......................................................................................................................................... Needle, Acupuncture, Single Use ............................................................................................................................... Stocking, Medical Support (to Prevent Pooling of Blood in Legs) .............................................................................. Analyzer, Rigidity ......................................................................................................................................................... Device, Galvanic Skin Response Measurement ......................................................................................................... Device, Skin Potential Measurement ........................................................................................................................... Encephalogram Telemetry System .............................................................................................................................. Vibratory Counter-Stimulation ...................................................................................................................................... Sheet, Recording, Breast Examination ........................................................................................................................ Drain, Cervical ............................................................................................................................................................. Forceps, Obstetrical ..................................................................................................................................................... Clamp, Umbilical .......................................................................................................................................................... Speculum, Vaginal, Nonmetal ..................................................................................................................................... 18:01 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\11JYN1.SGM 11JYN1 EKO ELS KKO EJI ETS KLX ETW EPF LZI KHL ETC MCK FCQ FCR FCW FGS GCT GCW NTN OCY FCS EZP FHN MND LQC EZO EXF PIA EZM FAT KNQ KOE NIH FKI EXD FGD PLI ERY EYX EYY FNW HMT HMW KGW FQP FSQ FSS FSW FSX FSY FSZ FTA FTD FTG GBC FZG FZH FZI BWJ MQX DWL GZM GZO HCJ GYE OVP NHM HFL HDA HFW HIB 31980 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices TABLE 1—CLASS II DEVICES—Continued mstockstill on DSK30JT082PROD with NOTICES 21 CFR section 884.4530 884.4530 884.4900 884.4900 884.4900 884.5200 884.5390 884.5390 884.5390 884.5400 884.5425 884.6150 886.1120 886.1120 886.1250 886.1570 886.1570 886.1570 886.1780 886.1945 886.4150 886.4250 886.4335 886.4335 886.4335 886.4400 886.4440 886.4790 886.4790 888.1240 888.4580 888.4580 890.1450 890.5100 890.5100 890.5110 890.5250 890.5360 890.5500 890.5575 892.1000 892.1560 892.1610 892.1610 892.1610 892.1610 892.1610 892.1650 892.1650 892.1670 892.1680 892.1680 892.1730 892.1820 892.1850 892.1860 892.1870 892.1900 892.1900 892.1900 892.1900 892.1900 892.2030 892.2030 892.2040 892.2040 892.5730 ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... ........... VerDate Sep<11>2014 Product code Device type Speculum, Vaginal, Nonmetal, Fiberoptic ................................................................................................................... Clamp and Cutter, Umbilical ........................................................................................................................................ Table, Obstetrical, AC-Powered (and Accessories) .................................................................................................... Table, Obstetrical, Manual (and Accessories) ............................................................................................................. Table, Obstetric (and Accessories) ............................................................................................................................. Hemorrhoid Prevention Pressure Wedge .................................................................................................................... Heater, Perineal, Direct Contact .................................................................................................................................. Heater, Perineal, Radiant, Non-Contact ...................................................................................................................... Heater, Perineal ........................................................................................................................................................... Cup, Menstrual ............................................................................................................................................................ Pad, Menstrual, Scented ............................................................................................................................................. Micromanipulators and Microinjectors, Assisted Reproduction ................................................................................... Photorefractor .............................................................................................................................................................. Camera, Ophthalmic, General-Use ............................................................................................................................. Euthyscope, AC-Powered ............................................................................................................................................ Ophthalmoscope, AC-Powered ................................................................................................................................... Ophthalmoscope, Battery-Powered ............................................................................................................................. Ophthalmoscopes, Replacement Batteries, Hand-Held .............................................................................................. Retinoscope, AC-Powered .......................................................................................................................................... Transilluminator, AC-Powered ..................................................................................................................................... Tubing, Replacement, Phacofragmentation Unit ......................................................................................................... Unit, Electrolysis, AC-Powered, Ophthalmic ............................................................................................................... Headlight, Fiberoptic Focusing .................................................................................................................................... Light, Headband, Surgical ........................................................................................................................................... Headlamp, Operating, AC-Powered ............................................................................................................................ Locator, Metal, Electronic ............................................................................................................................................ Magnet, AC-Powered .................................................................................................................................................. Sponge, Ophthalmic .................................................................................................................................................... Eye Tray ...................................................................................................................................................................... Dynamometer, AC-Powered ........................................................................................................................................ Instrument, Surgical, Sonic and Accessory/Attachment .............................................................................................. System, Cement Removal Extraction .......................................................................................................................... Hammer, Reflex, Powered .......................................................................................................................................... Bath, Hydro-Massage .................................................................................................................................................. Bath, Sitz, Powered ..................................................................................................................................................... Bath, Paraffin ............................................................................................................................................................... Cabinet, Moist Steam .................................................................................................................................................. Exerciser, Measuring ................................................................................................................................................... Lamp, Infrared, Therapeutic Heating ........................................................................................................................... Device, Warning, Overload, External Limb, Powered ................................................................................................. MRI Disposable Kit ...................................................................................................................................................... Biopsy Needle Guide Kit ............................................................................................................................................. Aperature, Radiographic .............................................................................................................................................. Cone, Radiographic ..................................................................................................................................................... Collimator, Automatic, Radiographic ........................................................................................................................... Collimator, Manual, Radiographic ................................................................................................................................ Device, Beam Limiting, X-Ray, Diagnostic .................................................................................................................. Arthrogram Tray ........................................................................................................................................................... Radiology Dental Tray ................................................................................................................................................. Device, Spot-Film ........................................................................................................................................................ Radiographic Contrast Tray ......................................................................................................................................... Radiology Diagnostic Kit .............................................................................................................................................. Discography Kit ............................................................................................................................................................ Chair, Pneumocephalographic .................................................................................................................................... Cassette, Radiographic Film ........................................................................................................................................ Changer, Radiographic Film/Cassette ......................................................................................................................... Programmer, Changer, Film/Cassette, Radiographic .................................................................................................. Controller, Temperature, Radiographic ....................................................................................................................... Dryer, Film, Radiographic ............................................................................................................................................ Processor, Radiographic-Film, Automatic, Dental ....................................................................................................... Processor, Radiographic-Film, Automatic ................................................................................................................... Processor, Cine Film ................................................................................................................................................... Digitizer, Image, Radiological ...................................................................................................................................... Digitizer, Images, Ophthalmic ...................................................................................................................................... Camera, Multi Format, Radiological ............................................................................................................................ Device, Hardcopy, Images, Ophthalmic ...................................................................................................................... Prostate Seeding Kit .................................................................................................................................................... 18:01 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\11JYN1.SGM 11JYN1 HIC NBZ HDD HHP KNC OOA HGZ HHA KND HHE HHL MQJ MMF PJZ HMK HLI HLJ MSG HKL HJM MSR HRO FCT FSR HPQ HPM HPO HOZ OJK LBB JDX LZV IKO ILJ ILM IMC IMB ISD ILY IRN OIM OIJ IZS IZT IZW IZX KPW OII OIK IXL OIO OIP OIL HBK IXA KPX IZP EGT EGW EGY IXW IXX LMA NFH LMC NFI OIN Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices In table 2, FDA is identifying a list of class II devices that no longer require premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in §§ 862.9 to 892.9, as well as the indicated partial exemption limitations. Devices listed in table 2 are now exempt, but only if they are in concurrent compliance with both the 31981 partial exemption limitation specified in table 2 and its corresponding general limitation found in the .9 section of Parts 862 to 892 of Title 21 of the CFR. TABLE 2—CLASS II DEVICES 21 CFR Section Exempt product code Device type Former product code (non-exempt) Enzyme Immunoassay, Amphetamine. PUX ............... DKZ ................ 862.3100 ......... Radioimmunoassay, Amphetamine. PUX ............... DJP ................ 862.3100 ......... Thin Layer Chromatography, Amphetamine. PUX ............... DIT ................. 862.3100 ......... Gas Chromatography, Amphetamine. PUX ............... DOD ............... 862.3100 ......... Liquid Chromatography, Amphetamine. PUX ............... DNI ................. 862.3100 ......... Free Radical Assay, Amphetamine. PUX ............... DJL ................. 862.3150 ......... mstockstill on DSK30JT082PROD with NOTICES 862.3100 ......... Enzyme Immunoassay, Barbiturate. PUY ............... DIS ................. VerDate Sep<11>2014 18:01 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 Partial exemption limitation Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) E:\FR\FM\11JYN1.SGM 11JYN1 31982 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices TABLE 2—CLASS II DEVICES—Continued Device type Exempt product code Former product code (non-exempt) 862.3150 ......... Radioimmunoassay, Barbiturate. PUY ............... DKN ............... 862.3150 ......... Thin Layer Chromatography, Barbiturate. PUY ............... DKX ................ 862.3150 ......... Mercury Dithiazone, Colorimetry, Barbiturate. PUY ............... DJN ................ 862.3150 ......... Hemagglutination Inhibition, Barbiturate. PUY ............... DLX ................ 862.3150 ......... Gas Liquid Chromatography, Barbiturate. PUY ............... DMF ............... 862.3150 ......... High Pressure Liquid Chromatography, Barbiturate. PUY ............... KZY ................ 862.3170 ......... Enzyme Immunoassay, Benzodiazepine. PUZ ............... JXM ................ 862.3170 ......... mstockstill on DSK30JT082PROD with NOTICES 21 CFR Section High Pressure Liquid Chromatography, Benzodiazepine. PUZ ............... LAA ................ VerDate Sep<11>2014 18:01 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Partial exemption limitation Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) E:\FR\FM\11JYN1.SGM 11JYN1 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices 31983 TABLE 2—CLASS II DEVICES—Continued 21 CFR Section Exempt product code Device type Former product code (non-exempt) Test, Benzodiazepine, Over The Counter. PUZ ............... NFV ................ 862.3170 ......... Gas Chromatography, Benzodiazepine. PUZ ............... KZZ ................ 862.3170 ......... Thin Layer Chromatography, Benzodiazepine. PUZ ............... LAB ................ 862.3250 ......... Enzyme Immunoassay, Cocaine and Cocaine Metabolites. PVA ............... DIO ................. 862.3250 ......... Radioimmunoassay, Cocaine Metabolite. PVA ............... KLN ................ 862.3250 ......... Enzyme Immunoassay, Cocaine. PVA ............... JXO ................ 862.3250 ......... Hemagglutination, Cocaine Metabolites (Benzoylecgonine). PVA ............... DLN ................ 862.3250 ......... mstockstill on DSK30JT082PROD with NOTICES 862.3170 ......... Thin Layer Chromatography, Cocaine. PVA ............... DMN ............... VerDate Sep<11>2014 18:01 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 Partial exemption limitation Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) E:\FR\FM\11JYN1.SGM 11JYN1 31984 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices TABLE 2—CLASS II DEVICES—Continued Device type Exempt product code Former product code (non-exempt) 862.3250 ......... Free Radical Assay, Cocaine PVA ............... DIR ................. 862.3250 ......... Gas Chromatography, Cocaine. PVA ............... DIN ................. 862.3250 ......... Thin Layer Chromatography, Benzoylecgonine. PVA ............... DOM ............... 862.3250 ......... High Pressure Liquid Chromatography, Cocaine and Cocaine Metabolites. PVA ............... LAC ................ 862.3270 ......... High Pressure Liquid Chromatography, Codeine. PVB ............... LAE ................ 862.3270 ......... Thin Layer Chromatography, Codeine. PVB ............... DLD ................ 862.3270 ......... Gas Chromatography, Codeine. PVB ............... LAD ................ 862.3580 ......... mstockstill on DSK30JT082PROD with NOTICES 21 CFR Section Radioimmunoassay, LSD (125–I). PVC ............... DLB ................ VerDate Sep<11>2014 18:01 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 Partial exemption limitation Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) E:\FR\FM\11JYN1.SGM 11JYN1 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices 31985 TABLE 2—CLASS II DEVICES—Continued Device type Exempt product code Former product code (non-exempt) 862.3580 ......... Free Radical Assay, LSD ...... PVC ............... DOL ................ 862.3610 ......... Gas Chromatography, Methamphetamine. PVD ............... LAF ................ 862.3610 ......... Thin Layer Chromatography, Methamphetamine. PVD ............... DJC ................ 862.3610 ......... High Pressure Liquid Chromatography, Methamphetamine. PVD ............... LAG ................ 862.3610 ......... Test, Methamphetamine, Over The Counter. PVD ............... NGG ............... 862.3620 ......... Enzyme Immunoassay, Methadone. PVE ............... DJR ................ 862.3620 ......... Hemagglutination Inhibition, Methadone. PVE ............... DIW ................ 862.3620 ......... mstockstill on DSK30JT082PROD with NOTICES 21 CFR Section Gas Chromatography, Methadone. PVE ............... DMB ............... VerDate Sep<11>2014 18:01 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 Partial exemption limitation Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) E:\FR\FM\11JYN1.SGM 11JYN1 31986 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices TABLE 2—CLASS II DEVICES—Continued 21 CFR Section Exempt product code Device type Former product code (non-exempt) Thin Layer Chromatography, Methadone. PVE ............... DKR ............... 862.3620 ......... Liquid Chromatography, Methadone. PVE ............... DNT ................ 862.3620 ......... Free Radical Assay, Methadone. PVE ............... DPP ................ 862.3630 ......... Radioimmunoassay, Methaqualone. PVF ................ KXS ................ 862.3640 ......... Thin Layer Chromatography, Morphine. PVG ............... DNK ............... 862.3640 ......... Radioimmunoassay, Morphine (123–I), Goat Antibody Ammonium Sulfate Sep.. PVG ............... DOE ............... 862.3640 ......... Fluorometry, Morphine .......... PVG ............... DJJ ................. 862.3640 ......... mstockstill on DSK30JT082PROD with NOTICES 862.3620 ......... Liquid Chromatography, Morphine. PVG ............... DPK ................ VerDate Sep<11>2014 18:01 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Partial exemption limitation Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) E:\FR\FM\11JYN1.SGM 11JYN1 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices 31987 TABLE 2—CLASS II DEVICES—Continued 21 CFR Section Exempt product code Device type Former product code (non-exempt) Gas Chromatography, Morphine. PVG ............... DMY ............... 862.3640 ......... Hemagglutination Inhibition, Morphine. PVG ............... DLR ................ 862.3640 ......... Free Radical Assay, Morphine. PVG ............... DOK ............... 862.3640 ......... Radioimmunoassay, Morphine (3–H), Goat Antibody Ammonium Sulfate Sep.. PVG ............... DIQ ................. 862.3640 ......... Radioimmunoassay, Morphine-Barbiturate (125–I), Goat Antibody. PVG ............... DNA ............... 862.3650 ......... Enzyme Immunoassay, Opiates. PVH ............... DJG ................ 862.3650 ......... Gas Chromatography, Opiates. PVH ............... DJF ................ 862.3650 ......... mstockstill on DSK30JT082PROD with NOTICES 862.3640 ......... Hemagglutination, Opiates .... PVH ............... DLT ................ VerDate Sep<11>2014 18:01 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 Partial exemption limitation Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) E:\FR\FM\11JYN1.SGM 11JYN1 31988 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices TABLE 2—CLASS II DEVICES—Continued 21 CFR Section Exempt product code Device type Former product code (non-exempt) Thin Layer Chromatography, Opiates. PVH ............... LAI .................. 862.3650 ......... Free Radical Assay, Opiates PVH ............... DKT ................ 862.3650 ......... High Pressure Liquid Chromatography, Opiates. PVH ............... LAH ................ 862.3700 ......... Enzyme Immunoassay, Propoxyphene. PVI ................. JXN ................ 862.3700 ......... Thin Layer Chromatography, Propoxyphene. PVI ................. DPN ............... 862.3700 ......... Gas Chromatography, Propoxyphene. PVI ................. LAJ ................. 862.3700 ......... High Pressure Liquid ChroPVI ................. matography, Propoxyphene. LAK ................ 862.3870 ......... mstockstill on DSK30JT082PROD with NOTICES 862.3650 ......... Enzyme Immunoassay, Cannabinoids. LDJ ................. VerDate Sep<11>2014 18:01 Jul 10, 2017 Jkt 241001 PVJ ................ PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Partial exemption limitation Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) E:\FR\FM\11JYN1.SGM 11JYN1 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices 31989 TABLE 2—CLASS II DEVICES—Continued 21 CFR Section Exempt product code Device type Former product code (non-exempt) Reagents, Test, Tetrahydrocannabinol. PVJ ................ DKE ................ 862.3870 ......... Radioimmunoassay, Cannabinoid(S). PVJ ................ LAT ................ 862.3910 ......... High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs. PVK ............... LFI .................. 862.3910 ......... U.V. Spectrometry, Tricyclic Antidepressant Drugs. PVK ............... LFH ................ 862.3910 ......... Thin Layer Chromatography, Tricyclic Antidepressant Drugs. PVK ............... MLK ................ 866.5750 ......... System, Test, Radioallergosorbent (RAST) Immunological. Analyzer, Nitrogen Dioxide .... PUW .............. DHB ............... 868.2385 ......... PUG ............... MRQ ............... 870.1330 ......... Wire, Guide, Catheter ........... PTL ................ DQX ............... 870.1650 ......... Syringe, Balloon Inflation ...... PTM ............... MAV ............... 870.2770 ......... Analyzer, Body Composition PUH ............... MNW .............. 870.4400 ......... Reservoir, Blood, Cardiopulmonary Bypass. Tester, Auditory Impedance .. PTN ............... DTN ................ 874.1090 ......... mstockstill on DSK30JT082PROD with NOTICES 862.3870 ......... PTO ............... ETY ................ 874.1090 ......... Tympanometer ...................... PTP ................ NAS ................ 876.1500 ......... Endoscopic Magnetic Retriever. Scissors For Cystoscope ...... PTQ ............... FCC ................ PTR ............... KGD ............... 876.1500 ......... VerDate Sep<11>2014 18:01 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 Partial exemption limitation Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.) Exemption is limited to devices classified under 21 CFR 866.5750 that are intended to detect any of the allergens included in table 3 of this document. Exemption is limited to standalone nitrogen dioxide analyzers and not those that are components of nitric oxide delivery systems intended to monitor nitrogen dioxide levels during inhaled nitric oxide therapy. Exemption is limited to accessory torque devices that are manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires. Exemption is limited to non-patient contacting balloon inflation syringes intended only to inflate/deflate balloon catheters and monitor pressure within the balloon. Exemption is limited to body composition analyzers which are not intended to diagnose or treat any medical condition. Exemption is limited to cardiopulmonary bypass blood reservoirs that do not contain defoamers or blood filters. Exemption is limited to auditory impedance testers that are in compliance with FDA-recognized consensus standard ANSI S3.39. Exemption is limited to tympanometers that are in compliance with FDA-recognized consensus standard ANSI S3.39. Exemption is limited to endoscopic magnetic retrievers intended for single use. Exemption is limited to sterile scissors for cystoscope intended for single use. E:\FR\FM\11JYN1.SGM 11JYN1 31990 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices TABLE 2—CLASS II DEVICES—Continued 21 CFR Section Device type Exempt product code Former product code (non-exempt) 876.1500 ......... Endoscopic Grasping/Cutting Instrument, Non-Powered. PTS ................ OCZ ............... 876.5010 ......... Catheter, Biliary, Surgical ...... PTT ................ GCA ............... 876.5630 ......... Catheter, Peritoneal, LongTerm Indwelling. Catheter, Peritoneal Dialysis, Single Use. System, Peritoneal, Automatic Delivery. PTU ............... FJS ................. PTV ................ FKO ................ PTW ............... FKX ................ 878.4370 ......... Drape, Surgical ...................... PUI ................. KKX ................ 878.4495 ......... Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile. Computerized Cognitive Assessment Aid. PTX ................ GAQ ............... PTY ................ PKQ ............... 884.1630 ......... Colposcope (and Colpomicroscope). PTZ ................ HEX ................ 884.4530 ......... Tenaculum, Uterine ............... PUA ............... HDC ............... 884.6120 ......... Accessory, Assisted Reproduction. PUB ............... MQG .............. 884.6130 ......... Microtools, Assisted Reproduction (Pipettes). Labware, Assisted Reproduction. Biomicroscope, Slit-Lamp, AC-Powered. PUC ............... MQH ............... PUD ............... MQK ............... PUE ............... HJO ................ Ocular Peg ............................ PUF ............... MQU ............... 876.5630 ......... 876.5630 ......... 882.1470 ......... 884.6160 ......... 886.1850 ......... 886.3320 ......... In table 2, FDA included devices classified under § 866.5750 (Radioallergosorbent (RAST) immunological test system). FDA does not believe that all devices classified under this regulation meet the Partial exemption limitation Exemption is limited to disposable, non-powered endoscopic grasping/cutting instruments intended for single use. Exemption is limited to surgical biliary catheters that do not include a balloon component. Exemption is limited to non-patient contacting catheter finger grips intended for single use. Exemption is limited to non-patient contacting catheter finger grips intended for single use. Exemption is limited to continuous ambulatory peritoneal dialysis (CAPD) belts and catheter stands that do not include weigh scales. Exemption is limited to surgical drapes that do not include an antimicrobial agent. Exemption is limited to steel monofilament sutures that are uncoated and do not incorporate barbs. Exemption is limited to computerized cognitive assessment aids that are not intended for diagnostic assessment of specific diseases or conditions and rely on inputs from visual cues, auditory cues, and/or functional use of the hand. Exemption is limited to standard colposcopes (and colpomicroscopes) that use only a white light source, do not use filters other than a green filter, do not include image analysis software, and are not smartphone-based. Exemption is limited to sterile uterine tenaculum devices that do not use suction and are intended for single use. Exemption is limited to simple embryo incubators with temperature, gas, and humidity control only; syringe pumps; collection tube warmers; dish/plate/microscope stage warmers; and controlled-rate cryopreservation freezers. Exemption is limited to assisted reproduction microtools (pipettes) manufactured from glass. Exemption is limited to dishes and plates that are intended for general assisted reproduction technology procedures. Exemption is limited to slit-lamp, AC-powered biomicroscopes intended only for the visual examination of the anterior segment of the eye, are classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, do not provide any quantitative output, and are not intended for screening or automated diagnostic indications. Exemption is limited to ocular pegs supplied sterile. exemption criteria from premarket notification requirements. The devices listed in table 3 are also classified under § 866.5750, but this subset no longer requires premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in § 866.9. While the non-exempt devices classified under § 866.5750 will retain product code ‘‘DHB’’, these devices listed in table 3 are reassigned product code ‘‘PUW.’’ TABLE 3—CLASS II DEVICES [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems] mstockstill on DSK30JT082PROD with NOTICES Allergen code Source (taxonomical name) Allergen product Grass Pollens g1 g3 g4 g5 g7 g8 .................... .................... .................... .................... .................... .................... VerDate Sep<11>2014 Sweet vernal grass .................................................................... Cocksfoot grass, Orchard grass ................................................ Meadow fescue .......................................................................... Rye-grass (perennial rye grass) ................................................ Common reed (common reed grass) ........................................ Meadow grass, Kentucky blue (June grass) ............................. 18:01 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 Anthoxanthum odoratum. Dactylis glomerata. Festuca elatior. Lolium perenne. Phragmites communis. Poa pratensis. E:\FR\FM\11JYN1.SGM 11JYN1 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices TABLE 3—CLASS II DEVICES—Continued [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems] Source (taxonomical name) Allergen code Allergen product g9 .................... Redtop, Bentgrass ..................................................................... g11 g12 g13 g14 g15 .................. .................. .................. .................. .................. Brome grass ............................................................................... Cultivated rye (cultivated rye grass) .......................................... Velvet grass ............................................................................... Cultivated oat (cultivated oat grass) .......................................... Cultivated wheat (cultivated wheat grass) ................................. g16 .................. g17 .................. g24 .................. Meadow foxtail (meadow foxtail grass) ..................................... Bahia grass ................................................................................ Wheat grass, Western ............................................................... g30 .................. g70 .................. Bluegrass, annual ...................................................................... Wild rye grass ............................................................................ g71 .................. g201 ................ g202 ................ g203 ................ g204 ................ g216 ................ g701 ................ g702 ................ g703 ................ Canary grass .............................................................................. Barley, cultivated ........................................................................ Maize, corn (cultivated corn) ..................................................... Salt grass ................................................................................... False oat-grass .......................................................................... Cyn d 1 ...................................................................................... Phl p 1.0102, Phl p 5.0101 ........................................................ Phl p 7.0101 ............................................................................... Phl p 12.0101 ............................................................................. Agrostis stolonifera Agrostis gigantea (Agrostis alba). Bromus inermis. Secale cereale. Holcus lanatus. Avena sativa. Triticum aestivum (Triticum spp.). Alopecurus pratensis. Paspalum notatum. Agropyron smithii (Elymus smithii). Poa annua. Elymus triticoides Elymus condensatus. Phalaris arundinacea. Hordeum vulgare. Zea mays. Distichlis spicata. Arrhenatherum elatius. Cynodon dactylon. Phleum pratense. Phleum pratense. Phleum pratense. Weed Pollens Western ragweed ....................................................................... False ragweed ........................................................................... w5 ................... Wormwood ................................................................................. w6 ................... w7 ................... w8 ................... Mugwort ..................................................................................... Marguerite, ox-eye daisy ........................................................... Dandelion ................................................................................... w9 ................... w10 ................. w11 ................. Plantain (English), Ribwort ........................................................ Goosefoot, lamb’s quarters ........................................................ Saltwort (prickly), Russian thistle ............................................... w12 ................. Goldenrod .................................................................................. w13 w14 w15 w16 ................. ................. ................. ................. Cocklebur, common ................................................................... Common pigweed (rough pigweed) ........................................... Scale, Lenscale .......................................................................... Rough marsh elder .................................................................... w17 w18 w19 w20 w21 w22 ................. ................. ................. ................. ................. ................. Firebush (Kochia) ....................................................................... Sheep sorrel ............................................................................... Wall pellitory ............................................................................... Nettle (Common stinging nettle) ................................................ Wall pellitory ............................................................................... Japanese hop (careless weed) .................................................. w23 w24 w27 w28 w33 w35 w36 mstockstill on DSK30JT082PROD with NOTICES w2 ................... w4 ................... ................. ................. ................. ................. ................. ................. ................. Yellow dock, Yellow dockweed .................................................. Spiny pigweed ............................................................................ Carnation .................................................................................... Rose ........................................................................................... Clover ......................................................................................... Mexican tea ................................................................................ Rabbit bush ................................................................................ w37 ................. w39 ................. Salt bush, annual ....................................................................... Water hemp, Western ................................................................ w41 w42 w43 w45 w46 Burrobrush ................................................................................. Poverty weed. Common sagebrush ................................................................... Alfalfa ......................................................................................... Dog fennel .................................................................................. ................. ................. ................. ................. ................. VerDate Sep<11>2014 19:51 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 Ambrosia psilostachya. Ambrosia acanthicarpa (Franseria acanthicarpa). Artemisia absinthium Artemisia annua. Artemisia vulgaris. Chrysanthemum leucanthemum. Taraxacum vulgare Taraxacum officinale. Plantago lanceolata. Chenopodium album. Salsola kali (Salsola pestifer). Solidago virgaurea (Solidago spp.) Xanthium commune. Amaranthus retroflexus. Atriplex lentiformis. Iva ciliate Iva annua. Kochia scoparia. Rumex acetosella. Parietaria officinalis. Urtica dioica. Parietaria judaica. Humulus japonicas (Humulus scandens). Rumex crispus. Amaranthus spinosus. Dianthus spp. Rosa rugosa. Trifolium pratense. Chenopodium ambrosioides. Ambrosia deltoidea (Franseria deltoides). Atriplex wrightii. Amaranthus rudis (Acnida tamariscina). Hymenoclea salsola. Artemisia tridentata. Medicago sativa. Eupatorium capillifolium. E:\FR\FM\11JYN1.SGM 11JYN1 31991 31992 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices TABLE 3—CLASS II DEVICES—Continued [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems] Allergen code w53 w67 w69 w70 w75 w82 Source (taxonomical name) Allergen product ................. ................. ................. ................. ................. ................. Geranium ................................................................................... Groundsel bush .......................................................................... Iodine bush ................................................................................ Ragweed, slender ...................................................................... Wing scale (wingscale) .............................................................. Careless weed ........................................................................... w90 ................. Japanese hop ............................................................................ w203 ............... w204 ............... w206 ............... w207 ............... w210 ............... w211 ............... w231 ............... w232 ............... w233 ............... w234 ............... w235 ............... w236 ............... a753 ................ Rape (rape pollen) ..................................................................... Sunflower ................................................................................... Camomile ................................................................................... Lupin .......................................................................................... Sugar-beet ................................................................................. Par j 2.0101 ............................................................................... Art v 1 ........................................................................................ Sal k 1 ........................................................................................ Art v 3 ........................................................................................ Pla l 1 ......................................................................................... Che a 1.0101 ............................................................................. Mer a 1.0101 .............................................................................. Art v 1 ........................................................................................ Geranium spp. Baccharis halimifolia. Allenrolfea occidentalis. Ambrosia confertiflora. Atriplex canescens. Amaranthus palmeri Amaranthus hybridus. Humulus japonicas (Humulus scandens). Brassica napus. Helianthus annuus. Matricaria chamomilla. Lupinus spp. Beta vulgaris. Parietaria judaica. Artemisia vulgaris (Mugwort). Salsola kali. Artemisa vulgaris (LTP, Mugwort). Plantago lanceolata. Chenopodium album. Mercurialis annua. Artemisia vulgaris (Mugwort weed). Tree Pollens Box-elder (Maple) ...................................................................... t2 ..................... t4 ..................... Gray alder, speckled alder (alder) ............................................. Hazel, hazelnut .......................................................................... t5 ..................... American beech (beech) ............................................................ t6 ..................... Mountain juniper, Mountain cedar ............................................. t8 ..................... t9 ..................... t10 ................... Elm ............................................................................................. Olive ........................................................................................... Walnut ........................................................................................ t11 ................... t61 ................... t12 ................... Maple leaf sycamore, London plane, Plane tree ....................... Sycamore ................................................................................... Willow ......................................................................................... t14 t15 t16 t18 ................... ................... ................... ................... Cottonwood (Eastern Cottonwood/Black Cottonwood) ............. White ash ................................................................................... White pine .................................................................................. Eucalyptus, gum-tree ................................................................. t19/t26 ............. t20 ................... Acacia ........................................................................................ Mesquite ..................................................................................... t21 ................... t22 ................... mstockstill on DSK30JT082PROD with NOTICES t1 ..................... Melaleuca, cajeput tree .............................................................. Pecan, hickory ........................................................................... t23 t24 t25 t27 t29 t30 t32 t33 t35 t37 t38 t40 t41 ................... ................... ................... ................... ................... ................... ................... ................... ................... ................... ................... ................... ................... Italian/Mediterranean/funeral cypress ........................................ Japanese cypress ...................................................................... Ash ............................................................................................. Maple, red .................................................................................. Acacia ........................................................................................ Birch, white ................................................................................ Willow, black .............................................................................. Ash, Arizona ............................................................................... Cedar, salt .................................................................................. Bald cypress (white bald cypress) ............................................. Elm, Chinese/Siberian ............................................................... Hazelnut tree .............................................................................. White hickory ............................................................................. t42 ................... t43 ................... t44 ................... Oak, red ..................................................................................... Loblolly pine ............................................................................... Hackberry ................................................................................... VerDate Sep<11>2014 19:51 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 Acer negundo. Acer saccharum. Alnus incana. Corylus avellana. Corylus americana. Fagus grandifolia. (Fagus americana). Juniperus ashei (Juniperus sabinoides). Ulmus americana. Olea europaea. Juglans californica Juglans nigra. Platanus acerifolia. Platanus occidentalis. Salix caprea Salix nigra. Populus deltoides. Fraxinus americana. Pinus strobus. Eucalyptus globulus. (Eucalyptus spp.). Acacia longifolia (Acacia spp.). Prosopis glandulosa/ Prosopis juliflora. Melaleuca quinquenervia (Melaleuca leucadendron). Carya illinoinensis (Carya pecan). Cupressus sempervirens. Chamaecyparis obtusa (Chamaecyparis spp.). Fraxinus excelsior. Acer rubrum. Acacia spp. Betula populifolia. Salix nigra. Fraxinus velutina. Tamarix gallica. Taxodium distichum. Ulmus pumila. Corylus americana. Carya alba (Carya tomentosa). Quercus rubra. Pinus taeda. Celtis occidentalis. E:\FR\FM\11JYN1.SGM 11JYN1 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices TABLE 3—CLASS II DEVICES—Continued [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems] Source (taxonomical name) Allergen product t45 ................... t47 ................... t48 ................... t49 ................... t50 ................... t51 ................... t52 ................... t54 ................... t55 ................... t56 ................... t57 ................... t60 ................... t61 ................... t70 ................... t71 ................... t72 ................... t73 ................... t77 ................... t80 ................... t81 ................... t83 ................... t90 ................... t96 ................... t103/ ................ t218 ................. t105 ................. t110 ................. t201 ................. t202 ................. mstockstill on DSK30JT082PROD with NOTICES Allergen code Cedar elm .................................................................................. Juniper, one seed ...................................................................... Pine, lodgepole .......................................................................... Pine, ponderosa ......................................................................... Beech, European ....................................................................... Tree of Heaven .......................................................................... Western white pine .................................................................... Russian olive .............................................................................. Scotch broom ............................................................................. Bayberry ..................................................................................... Red cedar .................................................................................. Western juniper .......................................................................... Sycamore ................................................................................... Mulberry (white mulberry) .......................................................... Red mulberry ............................................................................. Queen palm ............................................................................... Australian pine ........................................................................... Oak mix (red, white, black) ........................................................ Japanese cypress ...................................................................... Japanese alder .......................................................................... Mango tree ................................................................................. Walnut, black ............................................................................. Poplar, white (poplar) ................................................................. Virginia live oak (live oak) .......................................................... Ulmus crassifolia. Juniperus monosperma. Pinus contorta. Pinus ponderosa. Fagus sylvatica. Ailanthus altissima. Pinus monticola. Elaeagnus angustifolia. Cytisus scoparius. Myrica cerifera. Juniperus virginiana. Juniperus occidentalis. Platanus occidentalis. Morus alba. Morus rubra. Arecastrum romanzoffiamon. Casuarina equisetifolia. Quercus spp. Chamaecyparis obtusa. Alnus japonica. Mangifera indica. Juglans nigra. Populus alba. Quercus virginiana. Pepper tree ................................................................................ Orange tree ................................................................................ Spruce, Norway spruce ............................................................. Alder, smooth ............................................................................. t203 t205 t206 t207 t208 t209 t210 t211 t212 t213 t214 t215 t217 t217 t218 t218 t219 t219 t220 t221 t222 t223 t224 t225 t226 t227 t228 t229 t230 t232 t240 t241 t242 t243 t244 t245 t246 t280 t401 t402 Horse chestnut ........................................................................... Elder ........................................................................................... Chestnut ..................................................................................... Douglas fir .................................................................................. Linden ........................................................................................ Horn beam ................................................................................. Privet .......................................................................................... Sweet gum ................................................................................. Cedar ......................................................................................... Pine ............................................................................................ Date palm ................................................................................... Lilac ............................................................................................ Pepper tree ................................................................................ Red alder ................................................................................... Virginia live oak .......................................................................... Bayberry (bayberry/sweet gale) ................................................. Palo verde .................................................................................. Red cedar .................................................................................. Bet v 4 ........................................................................................ Bet v 2.0101, Bet v 4 ................................................................. Cypress (Arizona cypress) ......................................................... Oil palm ...................................................................................... Ole e 1 ....................................................................................... Bet v 6 ........................................................................................ Cup a 1 ...................................................................................... Ole e 7 ....................................................................................... Aspen, quaking .......................................................................... Eastern hemlock ........................................................................ Redwood (sequoia) .................................................................... Pussy willow ............................................................................... Ole e 9.0101 .............................................................................. Pla a 1.0101 ............................................................................... Pla a 2 ........................................................................................ Pla a 3.0101 ............................................................................... Cor a 1.0103 .............................................................................. Aln g 1.0101 ............................................................................... Cry j 1 ........................................................................................ Locust tree ................................................................................. Brazilian peppertree ................................................................... Mastic tree ................................................................................. Schinus molle. Citrus sinensis. Picea abies (Picea excelsa). Alnus incana spp. Rugosa (Alnus rugosa). Aesculus hippocastanum. Sambucus nigra. Castanea sativa. Pseudotsuga menziesii (Pseudotsuga taxifolia). Tilia cordata. Carpinus betulus. Ligustrum vulgare. Liquidambar styraciflua. Libocedrus decurrens. Pinus radiata. Phoenix canariensis. Syringa vulgaris. Schinus molle. Alnus rubra. Quercus virginiana. Myrica gale. Cercidium floridum. Juniperus virginiana. Betula verrucosa (Birch). Betula verrucosa (Birch). Cupressus arizonica. Elaeis guineensis. Olea europaea. Betula verrucosa (Birch). Cupressus arizonica. Olea Europaea. Populus tremuloides. Tsuga canadensis. Sequoia sempervirens. Salix discolor. Olea Europaea. Platanus acerifolia. Platanus acerifolia. Platanus acerifolia. Corylus avellana. Alnus glutinosa. Cryptomeria japonica. Robinia pseudoacacia. Schinus terebinthifolius. Pistacia lentiscus. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. VerDate Sep<11>2014 19:51 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\11JYN1.SGM 11JYN1 31993 31994 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices TABLE 3—CLASS II DEVICES—Continued [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems] Source (taxonomical name) Allergen code Allergen product t404 ................. t406 ................. a482 ................ Tree of heaven ........................................................................... Date palm ................................................................................... Ole e 1 ....................................................................................... Ailanthus altissima. Phoenix dactylifera. Olea europaea (Olive Oil). Mites d207 ................ d208 ................ Blo t 5.0101 ................................................................................ Lep d 2.0101 .............................................................................. Blomia tropicalis. Lepidoglyphus destructor. Microorganisms, Molds, Yeast m1 ................... m9 ................... Penicillium chrysogenum ........................................................... (Penicillium notatum) Cladosporium herbarum (Hormodendrum) ................................ Aspergillus fumigatus ................................................................. Mucor racemosus ...................................................................... Candida albicans ....................................................................... Botrytis cinerea .......................................................................... Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes, Helminthosporium interseminatum). Fusarium moniliforme (Fusarium proliferatum) .......................... m10 ................. Stemphylium botryosum ............................................................ m11 m12 m13 m14 ................. ................. ................. ................. Rhizopus nigricans ..................................................................... Aureobasidium pullulans ............................................................ Phoma betae .............................................................................. Epicoccum purpurascens ........................................................... m15 ................. m16 ................. Trichoderma viride ..................................................................... Curvularia lunata ........................................................................ m17 m18 m19 m20 m21 m22 m23 m24 m24 m25 m25 m26 m26 m27 m29 m30 m32 m34 m36 m37 m40 m43 m44 m45 m46 m47 m48 m49 m50 m51 m53 ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. Cladosporium fulvum ................................................................. Fusarium culmorum ................................................................... Aspergillus versicolor ................................................................. Mucor mucedo ........................................................................... Aspergillus clavatus ................................................................... Micropolyspora faeni .................................................................. Thermoactinomyces vulgaris ..................................................... Stachybotrys atra ....................................................................... Paecilomyces spp. ..................................................................... Aspergillus versicolor ................................................................. Penicillium brevicompactum ...................................................... Cladosporium cladosporioides ................................................... Penicillium citrinum .................................................................... Penicillium spp. .......................................................................... Aspergillus repens ..................................................................... Penicillium roqueforti .................................................................. Cladosporium cladosporioides ................................................... Serpula lacrymans ..................................................................... Aspergillus terreus ..................................................................... Trichophyton mentagrophytes ................................................... Aspergillus amstelodami ............................................................ Saccharomyces carlsberg .......................................................... Saccharomyces cerevisiae ........................................................ Hormodendrum hordei ............................................................... Bipolaris spicifera ....................................................................... Aspergillus nidulans ................................................................... Aspergillus oryzae ...................................................................... Fusarium oxysporum ................................................................. Micropolyspora faeni .................................................................. Thermoactinomyces vulgaris ..................................................... Microspora canis ........................................................................ m54 m63 m66 m67 m68 ................. ................. ................. ................. ................. Aspergillus flavus ....................................................................... Helminthosporium intersemin .................................................... Mucor plumbeus ........................................................................ Mycogone ................................................................................... Nigrospora oryzae ...................................................................... mstockstill on DSK30JT082PROD with NOTICES m2 m3 m4 m5 m7 m8 ................... ................... ................... ................... ................... ................... VerDate Sep<11>2014 19:51 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Penicillium chrysogenum (Penicillium notatum). Cladosporium herbarum (Hormodendrum). Aspergillus fumigatus. Mucor racemosus. Candida albicans. Botrytis cinerea. Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes). Fusarium moniliforme (Fusarium proliferatum). Stemphylium herbarum (Stemphylium botryosum). Rhizopus nigricans. Aureobasidium pullulans. Phoma betae. Epicoccum purpurascens (Epicoccum nigrum). Trichoderma viride. Curvularia lunata Curvularia specifera (K923044). Cladosporium fulvum. Fusarium culmorum. Aspergillus versicolor. Mucor mucedo. Aspergillus clavatus. Saccharopolyspora rectivirgula (Micropolyspora faeni). Thermoactinomyces vulgaris. Stachybotrys chartarum (Stachybotrys atra). Paecilomyces spp. Aspergillus versicolor. Penicillium brevicompactum. Cladosporium cladosporioides. Penicillium citrinum. Penicillium spp. Aspergillus repens. Penicillium roqueforti. Cladosporium cladosporioides. Serpula lacrymans. Aspergillus terreus. Trichophyton mentagrophytes. Aspergillus amstelodami. Saccharomyces carlsbergensis. Saccharomyces cerevisiae. Hormodendrum hordei. Bipolaris spicifera. Aspergillus nidulans. Aspergillus oryzae. Fusarium oxysporum. Saccharopolyspora rectivirgula (Micropolyspora faeni). Thermoactinomyces vulgaris. Microsporum canis (Microspora canis). Aspergillus flavus. Helminthosporium intersemin. Mucor plumbeus. Mycogone perniciosa. Nigrospora oryzae. E:\FR\FM\11JYN1.SGM 11JYN1 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices 31995 TABLE 3—CLASS II DEVICES—Continued [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems] Source (taxonomical name) Allergen code Allergen product m69 ................. Rhodotorula ................................................................................ m70 ................. Malassezia furfur (Pityrosporum orbiculare) .............................. m71 ................. m72 ................. m73 ................. Spondylocladium ........................................................................ Epidermophyton ......................................................................... Epicoccum nigrum ..................................................................... m80 ................. m80 ................. m81 ................. m88 ................. m93 ................. m94 ................. m201 ............... Staphylococcal enterotoxin A (Sta a SEA) ................................ Helminthosporium spp. .............................................................. Staphylococcal enterotoxin B (Sta a SEB) ................................ Stemphylium solani .................................................................... Gliocladium fimbriatum .............................................................. Phycomyces blakesleeanus ....................................................... Tilletia tritici (Ustilago nuda, Ustilago tritici) (Barley smut) ........ m202 m203 m204 m205 m207 m208 m209 ............... ............... ............... ............... ............... ............... ............... Acremonium kiliense (Cephalosporium acremonium) ............... Trichosporon pullulans ............................................................... Ulocladium chartarum ................................................................ Trichophyton rubrum .................................................................. Aspergillus niger ........................................................................ Chaetomium globosum .............................................................. Penicillium frequentans .............................................................. m209 ............... m210 ............... m211 ............... m211 ............... m212 ............... m212 ............... m213 ............... m214 ............... m215 ............... m218 ............... a3050 .............. m219 ............... m220 ............... m221 ............... m222 ............... m223 ............... m224 ............... m226 ............... m227 ............... m228 ............... m229 ............... m230 ............... m231 ............... m300 ............... m304 ............... m305 ............... m309 ............... m310 ............... m311 ............... m312 ............... Stachybotrys chartarum ............................................................. Trichophyton mentagrophytes var. goetzii ................................. Trichophyton mentagrophytes var. interdigitale ......................... Oat smut .................................................................................... Micropolyspora faeni .................................................................. Geotrichum candidum ................................................................ Bermuda grass smut .................................................................. Johnson grass smut ................................................................... Corn smut .................................................................................. Asp f 1.0101 ............................................................................... Asp r 1 ....................................................................................... Asp f 2 ........................................................................................ Asp f 3.0101 ............................................................................... Asp f 4 ........................................................................................ Asp f 6.0101 ............................................................................... Staphylococal enterotoxin C (Sta a SEC) ................................. Staphylococcal enterotoxin D (Sta a SED) ............................... Staphylococcal enterotoxin TSST (Sta a TSST) ....................... Malassezia spp. (Pityrosporum spp.) ........................................ Aspergillus flavus.. Alt a 1.0101 ................................................................................ Alt a 6.0101 ................................................................................ Cla h 8.0101 .............................................................................. Eurotium spp. ............................................................................. Aspergillus oryzae ...................................................................... Penicillium brevicompactum ...................................................... Aspergillus terreus ..................................................................... Aspergillus nidulans ................................................................... Aspergillus flavus ....................................................................... Aspergillus clavatus ................................................................... Rhodotorula rubra (Rhodotorula mucilaginosa). Malassezia furfur (Pityrosporum orbiculare). Spondylocladium spp. Epidermophyton floccosum. Epicoccum purpurascens (Epicoccum nigrum). Staphylococcus aureus. Helminthosporium spp. Staphylococcus aureus. Stemphylium solani. Gliocladium fimbriatum. Phycomyces blakesleeanus. Tilletia tritici (Ustilago nuda, Ustilago tritici). Acremonium kiliense (Cephalosporium acremonium). Trichosporon pullulans. Ulocladium chartarum. Trichophyton rubrum. Aspergillus niger. Chaetomium globosum. Penicillium glabrum (Penicillium frequentans). Stachybotrys chartarum (Stachybotrys atra). Trichophyton mentagrophytes var. goetzii. Trichophyton mentagrophytes var. interdigitale. Ustilago avenae. Saccharopolyspora rectivirgula (Micropolyspora faeni). Geotrichum candidum. Ustilago cynodontis. Sphacelotheca cruenta. Ustilago maydis. Aspergillus fumigatus. Aspergillus restrictus. Aspergillus fumigatus. Aspergillus fumigatus. Aspergillus fumigatus. Aspergillus fumigatus. Staphylococus aureus. Staphylococcus aureus. Staphylococcus aureus. Malassezia spp. (Pityrosporum spp.). Alternaria alternata (Alternaria tenuis). Alternaria alternata (Alternaria tenuis). Cladosporium herbarum (Hormodendrum). Eurotium spp. Aspergillus oryzae. Penicillium brevicompactum. Aspergillus terreus. Aspergillus nidulans. Aspergillus flavus. Aspergillus clavatus. Epidermal & Animal Guinea pig epithelium ................................................................ Pigeon droppings ....................................................................... e25 .................. mstockstill on DSK30JT082PROD with NOTICES e6 .................... e7 .................... Chicken serum ........................................................................... e26 e62 e70 e71 .................. .................. .................. .................. Parrot serum .............................................................................. Camel ......................................................................................... Goose feathers .......................................................................... Mouse epithelium ....................................................................... e73 .................. e74 .................. Rat epithelium ............................................................................ Rat urine proteins ...................................................................... VerDate Sep<11>2014 19:51 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 Cavia porcellus. Columba palumbus Columba livia. Gallus domesticus (Gallus gallus domesticus; Gallus spp.). Psittacoidea spp. Camelus dromedaries. Anser anser. Mus musculus (Mus spp.). Rattus norvegicus. Rattus norvegicus Rattus rattus. E:\FR\FM\11JYN1.SGM 11JYN1 31996 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices TABLE 3—CLASS II DEVICES—Continued [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems] Allergen product Source (taxonomical name) e75 .................. Rat serum proteins .................................................................... e76 .................. Mouse serum proteins ............................................................... e77 e78 e79 e80 e81 .................. .................. .................. .................. .................. Budgerigar droppings ................................................................. Budgerigar feathers ................................................................... Budgerigar serum proteins ........................................................ Goat epithelium .......................................................................... Sheep epithelium ....................................................................... e82 .................. Rabbit epithelium ....................................................................... e83 .................. Swine epithelium ........................................................................ e84 .................. Hamster epithelium .................................................................... e85 .................. e86 .................. e87 .................. Chicken feathers ........................................................................ Duck feathers ............................................................................. Rat epithelium, serum proteins, and urine proteins .................. e88 e89 e90 e91 .................. .................. .................. .................. Mouse epithelium, serum proteins, and urine proteins (mouse) Turkey feathers .......................................................................... Budgerigar serum proteins, feathers, and droppings ................ Pigeon serum proteins, feathers, and droppings ...................... e92 .................. e93 .................. e94 .................. a345 ................ e98 .................. e101 ................ a174 ................ e102 ................ e196 ................ e197 ................ e198 ................ e199 ................ e200 ................ e201 ................ e202 ................ e203 ................ e204 ................ e205 ................ e206 ................ e208 ................ e209 ................ e210 ................ e211 ................ Parrot serum proteins, feathers, and droppings ........................ Pigeon serum proteins ............................................................... Fel d 1.0101 ............................................................................... Fel d 1 ........................................................................................ Parrot droppings ........................................................................ Can f 1.0101 .............................................................................. Can f 1 ....................................................................................... Can f 2.0101 .............................................................................. Parakeet feathers ....................................................................... Parakeet droppings .................................................................... Parakeet serum .......................................................................... Canary bird serum ..................................................................... Canary bird droppings ............................................................... Canary bird feathers (Canary feathers) ..................................... Reindeer epithelium ................................................................... Mink epithelium .......................................................................... Bos d 6 ....................................................................................... Horse, serum proteins ............................................................... Rabbit, serum proteins ............................................................... Chinchilla epithelium .................................................................. Gerbil epithelium ........................................................................ Fox epithelium ............................................................................ Rabbit, urine proteins ................................................................. e212 ................ Swine, urine proteins ................................................................. e213 ................ e214 ................ e215 ................ mstockstill on DSK30JT082PROD with NOTICES Allergen code Parrot feathers ........................................................................... Finch feathers ............................................................................ Pigeon feathers .......................................................................... e216 e217 e218 e219 e220 e221 ................ ................ ................ ................ ................ ................ Deer epithelium .......................................................................... Ferret epithelium ........................................................................ Chicken droppings ..................................................................... Chicken, serum proteins ............................................................ Fel d 2, Cat serum albumin ....................................................... Can f 3 ....................................................................................... e222 e225 e226 e227 e228 e230 ................ ................ ................ ................ ................ ................ Swine serum albumin (Sus s PSA) ........................................... Lovebird feathers ....................................................................... Can f 5.0101 .............................................................................. Equ c 1.0101 .............................................................................. Fel d 4.0101 ............................................................................... Equ c 3 ....................................................................................... Rattus norvegicus Rattus rattus. Mus musculus (Mus spp.). Melopsittacus undulatus. Melopsittacus undulatus. Melopsittacus undulatus. Capra hircus. Ovis aries (Ovis spp.). Oryctolagus cuniculus (Oryctolagus spp.). Sus scrofa (Sus scrofa domesticus; Sus spp.). Cricetus cricetus, Mesocricetus auratus, and Phodopus sungorus. Gallus domesticus (Gallus gallus domesticus; Gallus spp.). Anas platyrhynchos. Rattus norvegicus Rattus rattus. Mus musculus (Mus spp.). Meleagris gallopavo. Melopsittacus undulatus. Streptopelia roseogrisea Psittacidae spp. Ara spp. Streptopelia roseogrisea. Felis domesticus. Felis domesticus. Psittacoidea spp. Canis familiaris (Canis domesticus). Canis familiaris (Canis domesticus). Canis familiaris (Canis domesticus). Nymphicus hollandicus. Nymphicus hollandicus. Nymphicus hollandicus. Serinus canarius. Serinus canarius. Serinus canarius. Rangifer tarandus. Mustela spp. Bos domesticus (Bos taurus; Bos spp.). Equus caballus (Equus spp.). Oryctolagus cuniculus (Oryctolagus spp.). Chinchilla laniger. Meriones unguiculatus. Vulpes vulpes. Oryctolagus cuniculus (Oryctolagus spp.). Sus scrofa (Sus scrofa domesticus; Sus spp.). Ara spp. Lonchura domestica. Streptopelia roseogrisea (Streptopelia spp.) Columbia spp. Dama dama. Mustela putorius. Gallus domesticus (Gallus gallus domesticus; Gallus spp.). Gallus domesticus (Gallus gallus domesticus; Gallus spp.). Felis domesticus. Canis familiaris (Canis domesticus) (Dog serum albumin). Sus scrofa (Sus scrofa domesticus; Sus spp.). Psittacoidea agapomis. Canis familiaris. Equus caballus. Felis domesticus. Equus caballus. VerDate Sep<11>2014 19:51 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\11JYN1.SGM 11JYN1 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices 31997 TABLE 3—CLASS II DEVICES—Continued [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems] Source (taxonomical name) Allergen code Allergen product e231 ................ Mus m 1 ..................................................................................... Mus musculus. Food Rice ............................................................................................ Pea (green pea) ......................................................................... White bean ................................................................................. Cayenne pepper ........................................................................ f21 f22 f26 f29 ................... ................... ................... ................... Sugar cane ................................................................................. Raspberry ................................................................................... Pork ............................................................................................ Watermelon ................................................................................ f31 f32 f33 f35 f43 f44 f45 f46 f47 f48 f49 ................... ................... ................... ................... ................... ................... ................... ................... ................... ................... ................... Carrot ......................................................................................... Oyster mushroom ...................................................................... Orange ....................................................................................... Potato ......................................................................................... Mother’s milk .............................................................................. Strawberry .................................................................................. Yeast, baker’s ............................................................................ Pepper, Red ............................................................................... Garlic .......................................................................................... Onion .......................................................................................... Apple .......................................................................................... f51 f52 f54 f55 f56 f57 f58 f59 f63 f67 f81 f82 f83 f86 f87 f88 f90 f92 f93 f94 f97 mstockstill on DSK30JT082PROD with NOTICES f9 ..................... f12 ................... f15 ................... f19 ................... ................... ................... ................... ................... ................... ................... ................... ................... ................... ................... ................... ................... ................... ................... ................... ................... ................... ................... ................... ................... ................... Bamboo shoot ............................................................................ Cacao/chocolate ........................................................................ Sweet potato .............................................................................. Common millet ........................................................................... Foxtail millet ............................................................................... Japanese millet .......................................................................... Pacific squid ............................................................................... Octopus ...................................................................................... Kefir ............................................................................................ Parmesan cheese ...................................................................... Cheese, cheddar type ................................................................ Cheese, mold type ..................................................................... Chicken ...................................................................................... Parsley ....................................................................................... Melon ......................................................................................... Mutton (lamb) ............................................................................. Malt ............................................................................................ Banana ....................................................................................... Cacao ......................................................................................... Pear ............................................................................................ Yam ............................................................................................ f97 ................... f98 ................... f102 ................. f105 ................. f109 ................. f110 ................. f118 ................. f119 ................. f120 ................. f121 ................. f122 ................. f127 ................. f131 ................. f136 ................. f139 ................. f140 ................. f141 ................. f152 ................. f155 ................. f157 ................. f158 ................. f160 ................. Chamomile tea ........................................................................... Gliadin ........................................................................................ Cantaloupe ................................................................................. Chocolate ................................................................................... Cottonseed ................................................................................. Giant radish ................................................................................ Zucchini ...................................................................................... Radish ........................................................................................ Venison ...................................................................................... Pinto bean .................................................................................. Cheese, American ..................................................................... Black-eyed pea .......................................................................... Black Olive ................................................................................. Red beet .................................................................................... Goat’s Cheese ........................................................................... Bran ............................................................................................ Corn (vegetables) ...................................................................... Green bell pepper ...................................................................... Brewer’s yeast ........................................................................... Duck ........................................................................................... Goose ......................................................................................... Camembert cheese .................................................................... VerDate Sep<11>2014 19:51 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 Oryza sativa. Pisum sativum. Phaseolus vulgaris. Capsicum frutescens (Capsicum annum). Saccharum officinarum. Rubus idaeus. Sus scrofa (Sus scrofa domesticus; Sus spp.). Citrullus lanatus (Citrullus vulgaris). Daucus carota. Pleurotus ostreatus. Citrus sinensis. Solanum tuberosum. Homo sapiens. Fragaria vesca (Fragaria spp.). Saccharomyces cerevisiae. Capsicum annuum. Allium sativum. Allium cepa. Malus x domestica (Malus spp.). Phyllostachys pubescens. Theobroma cacao. Ipomoea batatas. Panicum miliaceum. Setaria italica. Echinochloa crus-galli. Todarodes pacificus. Octopus vulgaris (Octopus spp.). NA. NA. NA. NA. Gallus domesticus (Gallus gallus domesticus; Gallus spp.). Petroselinum crispum. Cucumis melo Cucumis melo + Citrullus lanatus. Ovis aries (Ovis spp.). Hordeum vulgare. Musa spp. Theobroma cacao. Pyrus communis (Pyrus spp.). Dioscorea spp. Dioscorea opposita. Matricaria chamomilla. Triticum aestivum (Triticum spp.). Cucumis melo var. cantalupensis. Theobroma cacao. Gossypium hirsutum. Raphanus sativus. Cucurbita pepo. Raphanus sativus. Capreolus capeolus. Phaseolus vulgaris. NA. Vigna unguiculata. Olea europaea. Beta vulgaris var. conditiva. Capra aegagrus. NA. Zea mays. Capsicum annuum. Saccharomyces carlsbergensis. Anas domesticus. Anser anser. NA. E:\FR\FM\11JYN1.SGM 11JYN1 31998 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices TABLE 3—CLASS II DEVICES—Continued [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems] Source (taxonomical name) Allergen product f162 ................. f163 ................. f65 ................... f166 ................. f170 ................. f174 ................. f177 ................. f179 ................. f182 ................. f198 ................. f199 ................. f208 ................. f209 ................. f210 ................. f211 ................. f212 ................. Nectarine .................................................................................... Kohlrabi ...................................................................................... Perch. Leek ........................................................................................... Cheese (Switzerland) (Swiss cheese) ....................................... Fig .............................................................................................. Cranberry ................................................................................... Raisin ......................................................................................... Lima bean .................................................................................. Flaxseed (bruised grain) ............................................................ Untreated native milk ................................................................. Lemon ........................................................................................ Grapefruit ................................................................................... Pineapple ................................................................................... Blackberry .................................................................................. Mushroom (champignon) ........................................................... f213 ................. Rabbit ......................................................................................... f214 f215 f216 f217 f218 f219 f219 f220 f221 f222 f223 f225 f225 f226 f227 f229 f231 ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. Spinach ...................................................................................... Lettuce ....................................................................................... Cabbage ..................................................................................... Brussels sprouts ........................................................................ Paprika, sweet pepper ............................................................... Fennel seed ............................................................................... Sage ........................................................................................... Cinnamon ................................................................................... Coffee ......................................................................................... Tea ............................................................................................. Green olive ................................................................................. Summer squash, pumpkin ......................................................... Pumpkin ..................................................................................... Pumpkin seed ............................................................................ Sugar-beet seed ........................................................................ Safflower Seed ........................................................................... Milk, boiled ................................................................................. f234 f237 f241 f242 f244 f246 f247 f248 f254 f255 ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. Vanilla ........................................................................................ Apricot ........................................................................................ Gouda cheese ............................................................................ Cherry ........................................................................................ Cucumber ................................................................................... Guar, guar gum .......................................................................... Honey ......................................................................................... Rosemary ................................................................................... Plaice ......................................................................................... Plum ........................................................................................... f258 ................. f259 ................. Squid .......................................................................................... Grape ......................................................................................... f260 f261 f262 f263 mstockstill on DSK30JT082PROD with NOTICES Allergen code ................. ................. ................. ................. Broccoli ...................................................................................... Asparagus .................................................................................. Aubergine, eggplant ................................................................... Green pepper ............................................................................. f264 f265 f265 f266 f267 f268 f269 f270 f271 f272 f273 f274 f275 f276 ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. Eel .............................................................................................. Caraway ..................................................................................... Cumin ......................................................................................... Mace .......................................................................................... Cardamon .................................................................................. Clove .......................................................................................... Basil ........................................................................................... Ginger ........................................................................................ Anise .......................................................................................... Tarragon ..................................................................................... Thyme ........................................................................................ Marjoram .................................................................................... Lovage ....................................................................................... Fennel, fresh .............................................................................. VerDate Sep<11>2014 19:51 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 Prunus persica var. nucipersica. Brassica oleracea var. gongylodes. Allium porrum. NA. Ficus carica. Vaccinium macrocarpon. Vitis spp. Phaseolus lunatus. Linum usitatissimum. Bos domesticus (Bos taurus; Bos spp.). Citrus limon. Citrus paradisi. Ananas comosus. Rubus fruticosus. Agaricus hortensis (Agaricus spp.). Oryctolagus cuniculus (Oryctolagus spp.). Spinacia oleracea. Lactuca sativa. Brassica oleracea var. capitata. Brassica oleracea var. gem. Capsicum annuum. Foeniculum vulgare. Salvia officinalis. Cinnamomum spp. Coffea spp. Camellia sinensis. Olea europaea. Cucurbita pepo. Cucurbita maxima. Cucurbita pepo. Beta vulgaris. Carthamus tinctorius. Bos domesticus (Bos taurus; Bos spp.). Vanilla planifolia. Prunus armeniaca. NA. Prunus avium. Cucumis sativus. Cyamopsis tetragonoloba. NA. Rosmarinus officinalis. Pleuronectes platessa. Prunus domestica Prunus americana. Loligo spp. Vitis vinifera (Vitis spp.). Brassica oleracea var. italica (Brassica oleracea var. cultivar). Asparagus officinalis. Solanum melongena. Piper nigrum Capsicum annuum. Anguilla anguilla. Carum carvi. Cuminum cyminum. Myristica fragrans. Elettaria cardamomum. Syzygium aromaticum. Ocimum basilicum. Zingiber officinale. Pimpinella anisum. Artemisia dracunculus. Thymus vulgaris. Origanum majorana. Levisticum officinale. Foeniculum vulgare. E:\FR\FM\11JYN1.SGM 11JYN1 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices TABLE 3—CLASS II DEVICES—Continued [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems] Allergen code Source (taxonomical name) Allergen product mstockstill on DSK30JT082PROD with NOTICES f277 f278 f279 f280 f281 f282 f283 f284 f285 f286 f287 f288 f289 f291 f292 f293 f294 f295 f296 f297 f298 f299 f300 f301 f302 f305 f306 f307 f308 f310 f311 f315 f316 f317 f318 f319 f320 f321 f322 f324 f325 f328 f329 f330 f331 f332 f333 f336 f336 f337 f337 f338 f339 f339 f341 ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. Dill .............................................................................................. Bay leaf ...................................................................................... Chili pepper ................................................................................ Black pepper .............................................................................. Curry (Santa Maria) ................................................................... Nutmeg ....................................................................................... Oregano ..................................................................................... Turkey meat ............................................................................... Elk/moose meat ......................................................................... Mare’s milk ................................................................................. Red kidney bean ........................................................................ Blueberry .................................................................................... Date ............................................................................................ Cauliflower ................................................................................. Guava ......................................................................................... Papaya ....................................................................................... Passion fruit, Maracuja .............................................................. Carambola .................................................................................. Carob ......................................................................................... Gum arabic ................................................................................ Tragacanth ................................................................................. Sweet chestnut (chestnut) ......................................................... Pinto bean .................................................................................. Persimmon (kaki fruit, sharon) ................................................... Mandarin (tangerine, clementine, satsumas) ............................ Fenugreek .................................................................................. Lime ........................................................................................... Hake ........................................................................................... Sardine (pilchard) ....................................................................... Blue vetch .................................................................................. Megrim ....................................................................................... Green bean ................................................................................ Rape seed .................................................................................. Coriander ................................................................................... Jack fruit ..................................................................................... Beetroot ...................................................................................... Crayfish ...................................................................................... Horse meat ................................................................................ Red currant ................................................................................ Hop (fruit cone) .......................................................................... Saffron ........................................................................................ Fig .............................................................................................. Watermelon ................................................................................ Rose hip ..................................................................................... Saffron ........................................................................................ Mint ............................................................................................ Linseed ....................................................................................... Jujube ......................................................................................... Wine vinegar .............................................................................. Sole ............................................................................................ English sole ................................................................................ Wine, white ................................................................................ Allspice ....................................................................................... Wine, red .................................................................................... Cranberry ................................................................................... f342 f343 f344 f346 f347 f348 f349 f358 f360 f368 f374 f375 f377 f379 ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. ................. Olive (black, fresh) ..................................................................... Raspberry ................................................................................... Sage ........................................................................................... Chives ........................................................................................ Quinoa ........................................................................................ Litchi ........................................................................................... Chum salmon roe ...................................................................... Artichoke .................................................................................... Yogurt ......................................................................................... Black bass .................................................................................. Karaya gum ................................................................................ Horseradish ................................................................................ Maple syrup ............................................................................... Okra ........................................................................................... VerDate Sep<11>2014 19:51 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 Anethum graveolens. Laurus nobilis. Capsicum frutescens. Piper nigrum. NA. Myristica fragrans. Origanum vulgare. Meleagris gallopavo. Alces spp. Equus caballus (Equus spp.). Phaseolus vulgaris. Vaccinium myrtillus (Vaccinium spp.). Phoenix dactylifera. Brassica oleracea var. botrytis. Psidium guajava. Carica papaya. Passiflora edulis (Passiflora spp.). Averrhoa carambola. Ceratonia siliqua. Acacia senegal (Acacia spp.). Astragalus spp. Castanea sativa. Phaseolus spp. Diospyros kaki. Citrus reticulata. Trigonella foenum-graecum. Citrus aurantifolia. Merluccius merluccius. Sardina pilchardus. Lathyrus sativus. Lepidorhombus whiffiagonis. Phaseolus vulgaris. Brassica napus. Coriandrum sativum. Artocarpus heterophyllus. Beta vulgaris. Astacus astacus. Equus caballus (Equus spp.). Ribes sylvestre. Humulus lupulus. Colchicum autumnale. Ficus carica. Citrullus lanatus. Rosa spp. Crocus sativus. Mentha piperita. Linum usitatissimum. Ziziphus jujuba. Vitis vinifera (Vitis spp.). Solea solea. Parophrys vetulus. Vitis vinifera (Vitis spp.). Pimenta dioica. Vitis vinifera (Vitis spp.). Vaccinium oxycoccus Vaccinium macrocarpon. Olea europaea. Rubus idaeus. Salvia officinalis. Allium schoenoprasum. Chenopodium quinoa. Litchi chinensis. Oncorhynchus keta. Cynara scolymus. NA. Micropterus dolomieu (Micropterus dolomieui). Sterculia urens. Armoracia rusticana. NA. Abelmoschus esculentus. E:\FR\FM\11JYN1.SGM 11JYN1 31999 32000 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices TABLE 3—CLASS II DEVICES—Continued [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems] Allergen code f382 f401 f402 f403 f405 f406 Source (taxonomical name) Allergen product ................. ................. ................. ................. ................. ................. Beet, sugar ................................................................................. Loquat ........................................................................................ Fig .............................................................................................. Brewer’s yeast ........................................................................... Mint ............................................................................................ Arugula ....................................................................................... Beta vulgaris var. altissima. Eriobotrya japonica. Ficus carica. Saccharomyces cerevisiae. Mentha spp. Eruca vesicaria. House Dust h1 .................... h2 .................... h6 .................... Greer Labs., Inc. ........................................................................ Hollister-Stier Labs. .................................................................... Japan ......................................................................................... NA. NA. NA. Venoms & Insects i7 ..................... i8 ..................... Midge ......................................................................................... Moth ........................................................................................... i47 i49 i51 i54 i71 ................... ................... ................... ................... ................... Water flea ................................................................................... Deer fly ....................................................................................... Black ant .................................................................................... Flea mix (dog/cat), common flea ............................................... Mosquito ..................................................................................... i72 ................... i73 ................... Green nimitti ............................................................................... Blood worm ................................................................................ i75 ................... i76 ................... i77 ................... i78 ................... i80 ................... i201 ................. i202 ................. i203 ................. i204 ................. i205 ................. i208 ................. a45 .................. i209 ................. a670 ................ i210 ................. i211 ................. i213 ................. i214 ................. i215 ................. i216 ................. i217 ................. i220 ................. i221 ................. i222 ................. i223 ................. a46 .................. European hornet ........................................................................ Berlin beetle ............................................................................... European paper wasp ................................................................ Fly .............................................................................................. Bumblebee ................................................................................. Horse bot fly ............................................................................... Grain weevil ............................................................................... Mediterranean flour moth ........................................................... Horse fly ..................................................................................... Bumblebee ................................................................................. Api m 1.0101 .............................................................................. Api m 1 ....................................................................................... Ves v 5.0101 .............................................................................. Ves v 5 ....................................................................................... Pol d 5.0101 ............................................................................... Ves v 1.0101 .............................................................................. Api m 4 ....................................................................................... Api m 2 ....................................................................................... Api m 3 ....................................................................................... Api m 5 ....................................................................................... Api m 10 ..................................................................................... Bla g 1.0101 ............................................................................... Bla g 2.0101 ............................................................................... Bla g 5.0101 ............................................................................... Bla g 7 ........................................................................................ Api m 2 ....................................................................................... Chironomus yoshimatsui. Bombyx mori Heterocera spp. Daphnia spp. Chrysops spp. Camponotus pennsylvanicus. Ctenocephalides spp. Aedes communis Aedes spp. and Culex spp. Cladotanytarsus lewisi. Chironomus thummi Chironomusri parius Chironomus spp. Vespa crabro. Trogoderma angustum. Polistes dominulus. Musca domestica. Bombus pennsylvanicus. Gasterophilus intestinalis. Sitophilus granarius. Ephestia kuehniella (Anagasta kuehniella). Tabanus spp. Bombus terrestris. Apis mellifera. Apis mellifera. Vespula vulgaris. Vespula vulgaris. Polistes dominulus. Vespula vulgaris. Apis mellifera. Apis mellifera. Apis mellifera. Apis mellifera. Apis mellifera. Blattella germanica. Blattella germanica. Blattella germanica. Blattella germanica Apis mellifera. mstockstill on DSK30JT082PROD with NOTICES Miscellaneous o1 .................... o3 .................... o70 .................. o71 .................. o72 .................. o72 .................. o73 .................. o74 .................. o201 ................ o202 ................ o203 ................ o207 ................ o211 ................ VerDate Sep<11>2014 Cotton, crude fibers ................................................................... Cotton (treated) .......................................................................... Seminal fluid .............................................................................. Staphylococcus aureus .............................................................. Pichia pastoris crude extract customer specific ........................ Sperm-sediment ......................................................................... Pichia pastoris crude extr. vector customer specific ................. Pichia pastoris with vector customer specific ............................ Tobacco leaf, tobacco dust ........................................................ Artemia salina, fish feed ............................................................ Tetramin, fish feed ..................................................................... Daphnia, fish feed ...................................................................... Mealworm ................................................................................... 19:51 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 Gossypium spp. Gossypium spp. Homo sapiens. Staphylococcus aureus. Pichia pastoris. Homo sapiens. Pichia pastoris. Pichia pastoris. Nicotiana tabacum. Artemia salina. NA. Daphnia spp. Tenebrio molitor. E:\FR\FM\11JYN1.SGM 11JYN1 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices 32001 TABLE 3—CLASS II DEVICES—Continued [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems] Source (taxonomical name) Allergen code Allergen product o212 ................ o213 ................ o214 ................ o72 .................. o73 .................. Streptavidin ................................................................................ MBP (maltose binding protein) .................................................. CCD; MUXF3 from bromelain .................................................... Enterotoxin A (Sta a SEA) ......................................................... Enterotoxin B (Sta a SEB) ......................................................... Streptomyces avidini. Escherichia coli. Ananas comosus. Staphylococcus aureus. Staphylococcus aureus. Parasites p1 .................... p2 .................... p3 .................... p4 .................... p5 .................... p10 .................. p11 .................. Ascaris ....................................................................................... Echinococcus ............................................................................. Schistosoma ............................................................................... Anisakis (Herring Worm) ............................................................ Toxocara canis ........................................................................... Ani s 3.0101 ............................................................................... Ani s 1 ........................................................................................ Ascaris suum. Echinococcus granulosus. Schistosoma mansoni. Anisakis simplex (Anisakis spp.). Toxocara canis. Anisakis simplex (Anisakis spp.). Anisakis simplex (Anisakis spp.). mstockstill on DSK30JT082PROD with NOTICES Occupational k4 .................... k5 .................... k7 .................... k8 .................... k12 .................. k14 .................. k20 .................. k21 .................. k23 .................. k33 .................. k70 .................. k71 .................. k72 .................. k73 .................. k74 .................. k75 .................. k76 .................. k77 .................. k78 .................. k79 .................. k80 .................. k81 .................. k83 .................. k84 .................. k85 .................. k86 .................. k87 .................. k89 .................. k99 .................. k201 ................ k202 ................ k204 ................ k205 ................ k206 ................ k208 ................ k209 ................ k210 ................ k211 ................ k212 ................ k213 ................ k213 ................ k214 ................ k225 ................ k226 ................ k301 ................ k501 ................ k502 ................ k503 ................ k504 ................ VerDate Sep<11>2014 Threshing dust ........................................................................... Flax ............................................................................................ Hay Dust .................................................................................... Hop (hops) ................................................................................. Grain mill dust ............................................................................ Kapok ......................................................................................... Sheep’s wool (treated) (wool) .................................................... Sheep’s wool (Untreated) .......................................................... Straw Dust ................................................................................. Oak ............................................................................................. Green coffee bean ..................................................................... Castor bean ............................................................................... Ispaghula .................................................................................... Silk waste ................................................................................... Silk ............................................................................................. Isocyanate TDI (Toluene diisocyanate) ..................................... Isocyanate MDI (Diphenylmethane diisocyanate) ..................... Isocyanate HDI (Hexamethylen diisocyanate) ........................... Ethylene oxide ........................................................................... Phthalic anhydride ..................................................................... Formaldehyde/Formalin ............................................................. Ficus ........................................................................................... Cotton seed ................................................................................ Sunflower seed .......................................................................... Chloramin T ............................................................................... Trimellitic anhydride, TMA ......................................................... Asp o 21, alpha-amylase ........................................................... Orris root .................................................................................... HSA (Human Serum Albumin) (Hom s HSA) ............................ Car p 1, Papain .......................................................................... Ana c 2, Bromelain .................................................................... Maxatase .................................................................................... Alcalase ...................................................................................... Savinase, Protease 1 (Bac l Subtilisin) ..................................... Gal d 4, Lysozyme ..................................................................... Hexahydrophtalic anhydrid ........................................................ Maleic anhydride ........................................................................ Methyltetrahydrophtalic anhydrid ............................................... Abachi wood dust ...................................................................... Pepsin (Sus s Pepsin) ............................................................... TCPA .......................................................................................... Bougainvillea .............................................................................. Horse radish peroxidase (Arm r HRP) ...................................... Ascorbate oxidase (Cuc p ascorbate oxidase) .......................... Flour dust ................................................................................... Savinase customer specific ....................................................... Lipolase customer specific ......................................................... Termamyl customer specific ...................................................... Clazinase customer specific ...................................................... 19:51 Jul 10, 2017 Jkt 241001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 NA. NA. NA. Humulus lupulus. NA. NA. Ovis aries (Ovis spp.). Ovis aries (Ovis spp.). NA. NA. Coffea spp. Ricinus communis. Plantago psyllium/Plantago ovata. NA. Bombyx mori. NA. NA. NA. NA. NA. NA. Ficus benjamina (Ficus spp.). Gossypium hirsutum. Helianthus annuus. NA. NA. Aspergillus oryzae. Iris florentina. Homo sapiens. Carica papaya. Ananas comosus. Bacillus licheniformis. Bacillus spp. Bacillus spp. Gallus domesticus (Gallus gallus domesticus; Gallus spp.). NA. NA. NA. Triplochiton scleroxylon. Sus scrofa (Sus scrofa domesticus; Sus spp.). NA. Bougainvillea spp. Armoracia rusticana. Cucurbita pepo. Triticum spp. Proprietary knowledge of customer. Proprietary knowledge of customer. Proprietary knowledge of customer. Proprietary knowledge of customer. E:\FR\FM\11JYN1.SGM 11JYN1 32002 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices V. Reference The following reference is on display in the Dockets Management Staff (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https:// www.regulations.gov. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. FDA Guidance, ‘‘Procedures for Class II Device Exemptions From Premarket Notification, Guidance for Industry and CDRH Staff,’’ February 19, 1998, available at https://www.fda.gov/ downloads/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/UCM080199.pdf. Dated: July 5, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–14453 Filed 7–10–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2016–E–0627 and FDA– 2016–E–0629] Determination of Regulatory Review Period for Purposes of Patent Extension; Intercept Blood System for Platelets AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Intercept Blood System for Platelets and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device. SUMMARY: Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by September 11, 2017. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for mstockstill on DSK30JT082PROD with NOTICES DATES: VerDate Sep<11>2014 18:01 Jul 10, 2017 Jkt 241001 extension acted with due diligence during the regulatory review period by January 8, 2018. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 11, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 11, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 Instructions: All submissions received must include the Docket Nos. FDA– 2016–E–0627 and FDA–2016–E–0629 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; INTERCEPT BLOOD SYSTEM FOR PLATELETS.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, E:\FR\FM\11JYN1.SGM 11JYN1

Agencies

[Federal Register Volume 82, Number 131 (Tuesday, July 11, 2017)]
[Notices]
[Pages 31976-32002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14453]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1129]

Medical Devices; Exemptions From Premarket Notification: Class II
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a list of class II devices that the Agency has determined based on
established factors to no longer require premarket notification to
provide reasonable assurance of safety and effectiveness, subject to
certain limitations. FDA is publishing this notice of that
determination in accordance with procedures established by the 21st
Century Cures Act. This notice represents FDA's final determination
with respect to the list of class II devices proposed in a March 14,
2017, Federal Register document. The exemptions in this notice will
decrease regulatory burdens on the medical device industry and will
eliminate private costs and expenditures required to comply with
certain Federal regulations.

FOR FURTHER INFORMATION CONTACT: Bryce Bennett, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, email:
Gregory.Bennett@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of March 14, 2017 (82 FR 13609), FDA issued
a notice proposing to exempt a list of class II devices from the
premarket notification requirements under section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)), subject
to certain limitations. This notice was issued in accordance with the
21st Century Cures Act (Pub. L. 114-255), which was signed into law on
December 13, 2016. Section 3054 of that statute amended section 510(m)
of the FD&C Act. As amended, section 510(m)(1)(A) of the FD&C Act
provides that, within 90 days after enactment of the 21st Century Cures
Act and at least once every 5 years thereafter, FDA must publish in the
Federal Register a notice containing a list of each type of class II
device that FDA determines no longer requires a report under section
510(k) of the FD&C Act (generally referred to as a premarket
notification or ``510(k)'') to provide reasonable assurance of safety
and effectiveness. Within 210 days of enactment of the 21st Century
Cures Act, FDA must publish in the Federal Register a list representing
its final determination regarding the list of devices proposed in the
March 14, 2017, notice. Section 510(m)(3) of the FD&C Act provides that
upon the date that this final list is published in the Federal
Register, a 510(k) will no longer be required for the listed devices
and the applicable classification regulation for these devices shall be
deemed amended to incorporate such exemption. Interested persons were
given until May 15, 2017, to comment on the proposed list of class II
devices. After reviewing these comments and considering whether the
proposed list should be modified, FDA is now identifying its final
determination as to which of those devices are now exempt from
premarket notification requirements, subject to certain limitations, as
indicated in tables 1 to 3 of this notice.
In a future action, FDA intends to amend the codified language for
each listed device's classification regulation to reflect this final
determination. Persons with pending 510(k) submissions for devices that
are now exempt from premarket notification, subject to the limitations
on exemptions, should withdraw their submissions.
These exemptions will decrease regulatory burdens on the medical
device industry and will eliminate private costs and expenditures
required to comply with Federal regulation. Specifically, regulated
industry will no longer have to invest time and resources in premarket
notifications, including preparation of documents and data for
submission to FDA, payment of user fees associated with 510(k)
submissions, and responding to questions and requests for additional
information from FDA during 510(k) review.

II. Criteria for Exemption

There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
January 21, 1998, Federal Register notice (63 FR 3142) and subsequently
in the guidance the Agency issued on February 19, 1998, entitled
``Procedures for Class II Device Exemptions from Premarket
Notification, Guidance for Industry and CDRH Staff'' (``Class II 510(k)
Exemption Guidance'') (Ref. 1).

[[Page 31977]]

III. Limitations on Exemptions

FDA believes that the types of class II devices listed in this
notice should be exempt from the premarket notification requirements
found under section 510(k) of the FD&C Act. However, an exemption from
the requirement of premarket notification does not mean that the device
is exempt from any other statutory or regulatory requirements, unless
such exemption is explicitly provided by order or regulation. FDA's
determination that premarket notification is unnecessary to provide a
reasonable assurance of safety and effectiveness for devices listed in
this document is based, in part, on the assurance of safety and
effectiveness that other regulatory controls, such as current good
manufacturing practice requirements, provide.
In addition to being subject to the general limitations to the
exemptions found in Title 21 of the Code of Federal Regulations (CFR)
sections 862.9 to 892.9 (Sec. Sec. 862.9 to 892.9), when Agency
assessment determines that the factors laid out in the Class II 510(k)
Exemption Guidance (Ref. 1) do not weigh in favor of exemption for all
devices in a particular group, FDA may partially limit the exemption
from premarket notification requirements to specific devices within a
listed device type. In such situations where a partial exemption
limitation has been identified, FDA has determined that premarket
notification is necessary to provide a reasonable assurance of safety
and effectiveness for these devices. Partial exemption limitations can
be found in table 2 of this notice. FDA has assigned new product codes
to the device types that are now exempt subject to the partial
limitations in order to ensure that these devices can be separated from
devices that do not fall within the partial exemption limitation under
the existing product code (i.e., exempt and non-exempt devices within a
device type will have distinct product codes). If table 2 indicates
that a partial exemption limitation does apply to a device, then
affected device manufacturers should review their registration and
listing information to assess if they should list their device using
the original classification product code, which requires premarket
notification, or the new classification product code for the subset of
that device type that is now 510(k) exempt (subject to the general
limitations to the exemptions found in Sec. Sec. 862.9 to 892.9). In
table 2, for example, FDA is listing the exemption of the tympanometer
but limits the exemption to such devices that are in compliance with
FDA-recognized consensus standard ANSI S3.39. Tympanometers that comply
with this partial exemption limitation and the corresponding general
limitations in Sec. 874.9 are now exempt from the 510(k) requirements
and should be identified under new product code ``PTP'' in subsequent
registration and listing submissions. However, tympanometers not in
compliance with each of these exemption limitations remain subject to
the 510(k) requirements and will retain product code ``NAS.'' We
recommend that device manufacturers document in their records any
changes in the product code of their device with appropriate
justification.

IV. List of Class II Devices

In table 1, FDA is identifying the following list of class II
devices that no longer require premarket notification under section
510(k) of the FD&C Act, subject to the general limitations to the
exemptions found in Sec. Sec. 862.9 to 892.9:

Table 1--Class II Devices
------------------------------------------------------------------------
21 CFR section Device type Product code
------------------------------------------------------------------------
862.1020.................. Acid Phosphatase, CJN
Nitrophenylphosphate.
862.1020.................. Acid Phosphatase, Thymol CJR
Blue Monophosphate.
862.1020.................. Acid Phosphatase, CJX
Disodium Phenylphosphate.
862.1020.................. Acid Phosphatase, CKB
Naphthyl Phosphate.
862.1020.................. Acid Phosphatase, CKE
Thymolphthale
Inmonophosphate.
862.1020.................. Acid Phosphatase, Beta CKH
Glycerophosphate.
862.1020.................. Acid Phosphatase JFH
(Prostatic), Tartrate
Inhibited.
862.1090.................. Radioassay, Angiotensin KQN
Converting Enzyme.
862.1100.................. Vanillin Pyruvate, AST/ CIF
SGOT.
862.1100.................. Diazo, AST/SGOT.......... CIQ
862.1100.................. Hydrazone Colorimetry, CIS
AST/SGOT.
862.1100.................. NADH Oxidation/NAD CIT
Reduction, AST/SGOT.
862.1150.................. Calibrator, Primary...... JIS
862.1150.................. Calibrator, Secondary.... JIT
862.1150.................. Calibrator, Surrogate.... JIW
862.1150.................. Calibrator, Multi-Analyte JIX
Mixture.
862.1345.................. Drink, Glucose Tolerance. MRV
862.1350.................. Continuous Glucose PJT
Monitor Secondary
Display.
862.1445.................. Chromatographic CEX
Separation, Lactate
Dehydrogenase Isoenzymes.
862.1445.................. Electrophoretic, Lactate CFE
Dehydrogenase Isoenzymes.
862.1445.................. Differential Rate Kinetic JGF
Method, Lactate
Dehydrogenase Isoenzymes.
862.1509.................. System, Test, Urinary LPT
Methylmalonic Acid.
862.1685.................. Radioimmunoassay, CEE
Thyroxine-Binding
Globulin.
862.1700.................. Radioimmunoassay, Total CDX
Thyroxine.
862.1700.................. Enzyme Immunoassay, Non- KLI
Radiolabeled, Total
Thyroxine.
862.2265.................. High Throughput DNA PFF
Sequence Analyzer.
862.2570.................. Instrumentation For NSU
Clinical Multiplex Test
Systems.
862.2570.................. Real Time Nucleic Acid OOI
Amplification System.
862.2570.................. Mass Spectrometer For OTA
Clinical Multiplex Test
Systems.
862.2570.................. Micro Total Analysis OUE
Instrument System.
862.2570.................. Complete Gene Expression OVA
Profiling Accessory
Reagents.
862.2570.................. DNA Genetic Analyzer..... PCA
862.2570.................. Data Acquisition Software PQQ
862.3200.................. Calibrators, Drug Mixture DKB
862.3200.................. Calibrators, Drug DLJ
Specific.

[[Page 31978]]

862.3200.................. Calibrators, Ethyl DNN
Alcohol.
864.5400.................. Fibrometer............... GIE
864.5400.................. Timer, Coagulation....... JBT
864.5425.................. Control, Plasma, Abnormal GGC
864.5425.................. Plasma, Coagulation GGN
Control.
864.5425.................. Plasma, Control, Normal.. GIZ
864.6550.................. Control, Fecal Occult OSL
Blood.
864.6650.................. Study, Platelet Adhesive. JBZ
864.7275.................. Test, Euglobulin Lysis... JBO
864.7300.................. Fibrin Monomer JBN
Paracoagulation.
864.7340.................. Fibrinogen Standard...... GFX
864.7340.................. Plasma, Fibrinogen GIL
Control.
864.7375.................. Glutathione, Red-Cell.... GII
864.7375.................. Fluorescence, Visual JMH
Observation (Qual.,
U.V.), Glutathione
Reductase.
864.7375.................. Assay, Glutathione KQF
Reductase.
864.7415.................. Control, Hemoglobin, JCM
Abnormal.
864.7455.................. Stain, Fetal Hemoglobin.. GHQ
864.7500.................. Acid Hematin............. GGF
864.7720.................. Test, Prothrombin GGQ
Consumption.
864.7735.................. Prothrombin-Proconvertin JPF
and Thrombotest.
864.8150.................. Calibrator for Cell KRX
Indices.
864.8165.................. Calibrator for Hemoglobin KRZ
and Hematocrit
Measurement.
864.8175.................. Calibrator for Platelet KRY
Counting.
864.8185.................. Calibrator for Red-Cell KSA
and White-Cell Counting.
864.8625.................. Standards and Controls, GFS
Hemoglobin, Normal and
Abnormal.
864.8625.................. Control, White-Cell...... GGL
864.8625.................. Control, Hemoglobin...... GGM
864.8625.................. Control, Platelet........ GJP
864.8625.................. Control, Red-Cell........ GJR
864.8625.................. Control, Hematocrit...... GLK
864.8625.................. Mixture, Control, White- GLQ
Cell and Red-Cell
Indices.
864.8625.................. Control, Cell Counter, JCN
Normal and Abnormal.
864.8625.................. Mixture, Hematology JPK
Quality Control.
864.8625.................. Material, Quality NRF
Control, Semen Analysis.
864.8625.................. Control Material, Blood NRS
Circulating Epithelial
Cancer Cell.
864.9400.................. Solution, Stabilized KSK
Enzyme.
866.3395.................. Norovirus Serological OUC
Reagents.
866.5210.................. Immunochemical, CHN
Ceruloplasmin.
866.5210.................. Ceruloplasmin, Rhodamine, DCT
Antigen, Antiserum,
Control.
866.5210.................. Ceruloplasmin, FITC, DCY
Antigen, Antiserum,
Control.
866.5210.................. Ceruloplasmin, Antigen, DDB
Antiserum, Control.
866.5210.................. P-Phenyl-Enediamine/EDTA JFQ
(Spectrophotometric),
Ceruloplasmin.
866.5210.................. Indirect Copper Assay, JFR
Ceruloplasmin.
866.5470.................. Hemoglobin, Chain DAM
Specific, Antigen,
Antiserum, Control.
866.5620.................. Alpha-2-Macroglobulin, DDT
Rhodamine, Antigen,
Antiserum, Control.
866.5620.................. Alpha-2-Macroglobulin, DDY
FITC, Antigen,
Antiserum, Control.
866.5620.................. Alpha-2-Macroglobulin, DEB
Antigen, Antiserum,
Control.
866.5630.................. System, Test, Beta-2- JZG
Microglobulin
Immunological.
866.5910.................. Quality Control Material, NZB
Genetics, DNA.
868.1040.................. Algesimeter, Powered..... BSI
868.1400.................. Legging, Compression, Non- LLK
Inflatable.
868.2500.................. Monitor, Oxygen, KLK
Cutaneous, For Infant
Not Under Gas Anesthesia.
868.2500.................. Monitor, Oxygen, LPP
Cutaneous, For Uses
Other Than For Infant
Not Under Gas Anesthesia.
868.2550.................. Pneumotachometer......... JAX
868.5180.................. Bed, Rocking, Breathing CCO
Assist.
868.6250.................. Compressor, Air, Portable BTI
870.1390.................. Trocar................... DRC
870.1875.................. Lung Sound Monitor....... OCR
870.2675.................. Oscillometer............. DRZ
870.4280.................. Filter, Prebypass, KRJ
Cardiopulmonary Bypass.
870.4290.................. Adaptor, Stopcock, DTL
Manifold, Fitting,
Cardiopulmonary Bypass.
870.4340.................. Monitor and/or Control, DTW
Level Sensing,
Cardiopulmonary Bypass.
870.4420.................. Sucker, Cardiotomy DTS
Return, Cardiopulmonary
Bypass.
870.4430.................. Suction Control, DWD
Intracardiac,
Cardiopulmonary Bypass.
872.1720.................. Tester, Pulp............. EAT
872.3260.................. External Cleaning PME
Solution.
872.3300.................. Coating, Denture EBE
Hydrophilic, Resin.
872.3540.................. Pad, Denture, Over The EHR
Counter.
872.3540.................. Cushion, Denture, Over EHS
The Counter.
872.3560.................. Reliner, Denture, Over EBP
The Counter.
872.3590.................. Denture, Plastic, Tooth.. ELM

[[Page 31979]]

872.3600.................. Denture Preformed EKO
(Partially Prefabricated
Denture).
872.3890.................. Splint, Endodontic ELS
Stabilizing.
872.5550.................. Ring, Teething, Fluid- KKO
Filled.
872.6770.................. Syringe, Cartridge....... EJI
874.1120.................. Generator, Electronic ETS
Noise (for Audiometric
Testing).
874.1325.................. Electroglottograph....... KLX
874.3310.................. Calibrator, Hearing Aid/ ETW
Earphone and Analysis
Systems.
874.3320.................. Hearing Aid, Group and EPF
Auditory Trainer.
874.3320.................. Device, Assistive LZI
Listening.
874.3330.................. Hearing Aid, Master...... KHL
874.3430.................. Mold, Middle-Ear......... ETC
874.3730.................. Device, Voice MCK
Amplification.
876.1500.................. Light Source, FCQ
Incandescent, Diagnostic.
876.1500.................. Light Source, FCR
Photographic, Fiberoptic.
876.1500.................. Light Source, Fiberoptic, FCW
Routine.
876.1500.................. Carrier, Sponge, FGS
Endoscopic.
876.1500.................. Light Source, Endoscope, GCT
Xenon Arc.
876.1500.................. Transformer, Endoscope... GCW
876.1500.................. LED Light Source......... NTN
876.1500.................. Endoscopic Guide Wire, OCY
Gastroenterology-Urology.
876.4020.................. Light, Catheter, FCS
Fiberoptic, Glass,
Ureteral.
876.4270.................. Rod, Colostomy........... EZP
876.4400.................. Ligator, Hemorrhoidal.... FHN
876.4400.................. Ligator, Esophageal...... MND
876.4500.................. Lithotriptor, Biliary LQC
Mechanical.
876.4770.................. Urethrotome.............. EZO
876.5010.................. Bag, Bile Collecting..... EXF
876.5025.................. Vibrator for Climax PIA
Control of Premature
Ejaculation.
876.5365.................. Dilator, Esophageal EZM
(Metal Olive) Gastro-
Urology.
876.5365.................. Bougie, Esophageal, and FAT
Gastrointestinal, Gastro-
Urology.
876.5365.................. Dilator, Esophageal...... KNQ
876.5520.................. Dilator, Urethral........ KOE
876.5665.................. Disinfectant, Subsystem, NIH
Water Purification.
876.5820.................. Set, Dialyzer Holder..... FKI
876.5895.................. Irrigator, Ostomy........ EXD
876.5980.................. Catheter, Retention, FGD
Barium Enema With Bag.
876.5980.................. Gastrostomy Tube Holder.. PLI
878.4370.................. Drape, Surgical, ENT..... ERY
878.4370.................. Drape, Pure Latex Sheet, EYX
With Self-Retaining
Finger Cot.
878.4370.................. Drape, Urological, EYY
Disposable.
878.4370.................. Pad, Kelly............... FNW
878.4370.................. Drape, Patient, HMT
Ophthalmic.
878.4370.................. Drape, Microscope, HMW
Ophthalmic.
878.4370.................. Ring (Wound Protector), KGW
Drape Retention,
Internal.
878.4580.................. Lamp, Operating-Room..... FQP
878.4580.................. Light, Surgical, FSQ
Instrument.
878.4580.................. Light, Surgical, Floor FSS
Standing.
878.4580.................. Light, Surgical, FSW
Endoscopic.
878.4580.................. Light, Surgical, FSX
Connector.
878.4580.................. Light, Surgical, Ceiling FSY
Mounted.
878.4580.................. Light, Surgical, Carrier. FSZ
878.4580.................. Light, Surgical, FTA
Accessories.
878.4580.................. Lamp, Surgical........... FTD
878.4580.................. Illuminator, Remote...... FTG
878.4580.................. Lamp, Surgical, GBC
Incandescent.
878.5070.................. Apparatus, Air Handling, FZG
Bench.
878.5070.................. Apparatus, Air Handling, FZH
Room.
878.5070.................. Apparatus, Air Handling, FZI
Enclosure.
880.5580.................. Locator, Acupuncture BWJ
Point.
880.5580.................. Needle, Acupuncture, MQX
Single Use.
880.5780.................. Stocking, Medical Support DWL
(to Prevent Pooling of
Blood in Legs).
882.1020.................. Analyzer, Rigidity....... GZM
882.1540.................. Device, Galvanic Skin GZO
Response Measurement.
882.1560.................. Device, Skin Potential HCJ
Measurement.
882.1855.................. Encephalogram Telemetry GYE
System.
882.5895.................. Vibratory Counter- OVP
Stimulation.
884.2990.................. Sheet, Recording, Breast NHM
Examination.
884.3200.................. Drain, Cervical.......... HFL
884.4400.................. Forceps, Obstetrical..... HDA
884.4530.................. Clamp, Umbilical......... HFW
884.4530.................. Speculum, Vaginal, HIB
Nonmetal.

[[Page 31980]]

884.4530.................. Speculum, Vaginal, HIC
Nonmetal, Fiberoptic.
884.4530.................. Clamp and Cutter, NBZ
Umbilical.
884.4900.................. Table, Obstetrical, AC- HDD
Powered (and
Accessories).
884.4900.................. Table, Obstetrical, HHP
Manual (and Accessories).
884.4900.................. Table, Obstetric (and KNC
Accessories).
884.5200.................. Hemorrhoid Prevention OOA
Pressure Wedge.
884.5390.................. Heater, Perineal, Direct HGZ
Contact.
884.5390.................. Heater, Perineal, HHA
Radiant, Non-Contact.
884.5390.................. Heater, Perineal......... KND
884.5400.................. Cup, Menstrual........... HHE
884.5425.................. Pad, Menstrual, Scented.. HHL
884.6150.................. Micromanipulators and MQJ
Microinjectors, Assisted
Reproduction.
886.1120.................. Photorefractor........... MMF
886.1120.................. Camera, Ophthalmic, PJZ
General-Use.
886.1250.................. Euthyscope, AC-Powered... HMK
886.1570.................. Ophthalmoscope, AC- HLI
Powered.
886.1570.................. Ophthalmoscope, Battery- HLJ
Powered.
886.1570.................. Ophthalmoscopes, MSG
Replacement Batteries,
Hand-Held.
886.1780.................. Retinoscope, AC-Powered.. HKL
886.1945.................. Transilluminator, AC- HJM
Powered.
886.4150.................. Tubing, Replacement, MSR
Phacofragmentation Unit.
886.4250.................. Unit, Electrolysis, AC- HRO
Powered, Ophthalmic.
886.4335.................. Headlight, Fiberoptic FCT
Focusing.
886.4335.................. Light, Headband, Surgical FSR
886.4335.................. Headlamp, Operating, AC- HPQ
Powered.
886.4400.................. Locator, Metal, HPM
Electronic.
886.4440.................. Magnet, AC-Powered....... HPO
886.4790.................. Sponge, Ophthalmic....... HOZ
886.4790.................. Eye Tray................. OJK
888.1240.................. Dynamometer, AC-Powered.. LBB
888.4580.................. Instrument, Surgical, JDX
Sonic and Accessory/
Attachment.
888.4580.................. System, Cement Removal LZV
Extraction.
890.1450.................. Hammer, Reflex, Powered.. IKO
890.5100.................. Bath, Hydro-Massage...... ILJ
890.5100.................. Bath, Sitz, Powered...... ILM
890.5110.................. Bath, Paraffin........... IMC
890.5250.................. Cabinet, Moist Steam..... IMB
890.5360.................. Exerciser, Measuring..... ISD
890.5500.................. Lamp, Infrared, ILY
Therapeutic Heating.
890.5575.................. Device, Warning, IRN
Overload, External Limb,
Powered.
892.1000.................. MRI Disposable Kit....... OIM
892.1560.................. Biopsy Needle Guide Kit.. OIJ
892.1610.................. Aperature, Radiographic.. IZS
892.1610.................. Cone, Radiographic....... IZT
892.1610.................. Collimator, Automatic, IZW
Radiographic.
892.1610.................. Collimator, Manual, IZX
Radiographic.
892.1610.................. Device, Beam Limiting, X- KPW
Ray, Diagnostic.
892.1650.................. Arthrogram Tray.......... OII
892.1650.................. Radiology Dental Tray.... OIK
892.1670.................. Device, Spot-Film........ IXL
892.1680.................. Radiographic Contrast OIO
Tray.
892.1680.................. Radiology Diagnostic Kit. OIP
892.1730.................. Discography Kit.......... OIL
892.1820.................. Chair, HBK
Pneumocephalographic.
892.1850.................. Cassette, Radiographic IXA
Film.
892.1860.................. Changer, Radiographic KPX
Film/Cassette.
892.1870.................. Programmer, Changer, Film/ IZP
Cassette, Radiographic.
892.1900.................. Controller, Temperature, EGT
Radiographic.
892.1900.................. Dryer, Film, Radiographic EGW
892.1900.................. Processor, Radiographic- EGY
Film, Automatic, Dental.
892.1900.................. Processor, Radiographic- IXW
Film, Automatic.
892.1900.................. Processor, Cine Film..... IXX
892.2030.................. Digitizer, Image, LMA
Radiological.
892.2030.................. Digitizer, Images, NFH
Ophthalmic.
892.2040.................. Camera, Multi Format, LMC
Radiological.
892.2040.................. Device, Hardcopy, Images, NFI
Ophthalmic.
892.5730.................. Prostate Seeding Kit..... OIN
------------------------------------------------------------------------

[[Page 31981]]

In table 2, FDA is identifying a list of class II devices that no
longer require premarket notification under section 510(k) of the FD&C
Act, subject to the general limitations to the exemptions found in
Sec. Sec. 862.9 to 892.9, as well as the indicated partial exemption
limitations. Devices listed in table 2 are now exempt, but only if they
are in concurrent compliance with both the partial exemption limitation
specified in table 2 and its corresponding general limitation found in
the .9 section of Parts 862 to 892 of Title 21 of the CFR.

Table 2--Class II Devices
----------------------------------------------------------------------------------------------------------------
Exempt product Former product Partial exemption
21 CFR Section Device type code code (non-exempt) limitation
----------------------------------------------------------------------------------------------------------------
862.3100....................... Enzyme PUX.............. DKZ.............. Exemption is limited
Immunoassay, to test systems
Amphetamine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3100....................... Radioimmunoassay, PUX.............. DJP.............. Exemption is limited
Amphetamine. to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3100....................... Thin Layer PUX.............. DIT.............. Exemption is limited
Chromatography, to test systems
Amphetamine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3100....................... Gas PUX.............. DOD.............. Exemption is limited
Chromatography, to test systems
Amphetamine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3100....................... Liquid PUX.............. DNI.............. Exemption is limited
Chromatography, to test systems
Amphetamine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3100....................... Free Radical PUX.............. DJL.............. Exemption is limited
Assay, to test systems
Amphetamine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3150....................... Enzyme PUY.............. DIS.............. Exemption is limited
Immunoassay, to test systems
Barbiturate. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)

[[Page 31982]]

862.3150....................... Radioimmunoassay, PUY.............. DKN.............. Exemption is limited
Barbiturate. to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3150....................... Thin Layer PUY.............. DKX.............. Exemption is limited
Chromatography, to test systems
Barbiturate. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3150....................... Mercury PUY.............. DJN.............. Exemption is limited
Dithiazone, to test systems
Colorimetry, intended for
Barbiturate. employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3150....................... Hemagglutination PUY.............. DLX.............. Exemption is limited
Inhibition, to test systems
Barbiturate. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3150....................... Gas Liquid PUY.............. DMF.............. Exemption is limited
Chromatography, to test systems
Barbiturate. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3150....................... High Pressure PUY.............. KZY.............. Exemption is limited
Liquid to test systems
Chromatography, intended for
Barbiturate. employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3170....................... Enzyme PUZ.............. JXM.............. Exemption is limited
Immunoassay, to test systems
Benzodiazepine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3170....................... High Pressure PUZ.............. LAA.............. Exemption is limited
Liquid to test systems
Chromatography, intended for
Benzodiazepine. employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)

[[Page 31983]]

862.3170....................... Test, PUZ.............. NFV.............. Exemption is limited
Benzodiazepine, to test systems
Over The Counter. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3170....................... Gas PUZ.............. KZZ.............. Exemption is limited
Chromatography, to test systems
Benzodiazepine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3170....................... Thin Layer PUZ.............. LAB.............. Exemption is limited
Chromatography, to test systems
Benzodiazepine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3250....................... Enzyme PVA.............. DIO.............. Exemption is limited
Immunoassay, to test systems
Cocaine and intended for
Cocaine employment and
Metabolites. insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3250....................... Radioimmunoassay, PVA.............. KLN.............. Exemption is limited
Cocaine to test systems
Metabolite. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3250....................... Enzyme PVA.............. JXO.............. Exemption is limited
Immunoassay, to test systems
Cocaine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3250....................... Hemagglutination, PVA.............. DLN.............. Exemption is limited
Cocaine to test systems
Metabolites intended for
(Benzoylecgonine employment and
). insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3250....................... Thin Layer PVA.............. DMN.............. Exemption is limited
Chromatography, to test systems
Cocaine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)

[[Page 31984]]

862.3250....................... Free Radical PVA.............. DIR.............. Exemption is limited
Assay, Cocaine. to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3250....................... Gas PVA.............. DIN.............. Exemption is limited
Chromatography, to test systems
Cocaine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3250....................... Thin Layer PVA.............. DOM.............. Exemption is limited
Chromatography, to test systems
Benzoylecgonine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3250....................... High Pressure PVA.............. LAC.............. Exemption is limited
Liquid to test systems
Chromatography, intended for
Cocaine and employment and
Cocaine insurance testing
Metabolites. that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3270....................... High Pressure PVB.............. LAE.............. Exemption is limited
Liquid to test systems
Chromatography, intended for
Codeine. employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3270....................... Thin Layer PVB.............. DLD.............. Exemption is limited
Chromatography, to test systems
Codeine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3270....................... Gas PVB.............. LAD.............. Exemption is limited
Chromatography, to test systems
Codeine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3580....................... Radioimmunoassay, PVC.............. DLB.............. Exemption is limited
LSD (125-I). to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)

[[Page 31985]]

862.3580....................... Free Radical PVC.............. DOL.............. Exemption is limited
Assay, LSD. to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3610....................... Gas PVD.............. LAF.............. Exemption is limited
Chromatography, to test systems
Methamphetamine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3610....................... Thin Layer PVD.............. DJC.............. Exemption is limited
Chromatography, to test systems
Methamphetamine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3610....................... High Pressure PVD.............. LAG.............. Exemption is limited
Liquid to test systems
Chromatography, intended for
Methamphetamine. employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3610....................... Test, PVD.............. NGG.............. Exemption is limited
Methamphetamine, to test systems
Over The Counter. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3620....................... Enzyme PVE.............. DJR.............. Exemption is limited
Immunoassay, to test systems
Methadone. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3620....................... Hemagglutination PVE.............. DIW.............. Exemption is limited
Inhibition, to test systems
Methadone. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3620....................... Gas PVE.............. DMB.............. Exemption is limited
Chromatography, to test systems
Methadone. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)

[[Page 31986]]

862.3620....................... Thin Layer PVE.............. DKR.............. Exemption is limited
Chromatography, to test systems
Methadone. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3620....................... Liquid PVE.............. DNT.............. Exemption is limited
Chromatography, to test systems
Methadone. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3620....................... Free Radical PVE.............. DPP.............. Exemption is limited
Assay, Methadone. to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3630....................... Radioimmunoassay, PVF.............. KXS.............. Exemption is limited
Methaqualone. to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3640....................... Thin Layer PVG.............. DNK.............. Exemption is limited
Chromatography, to test systems
Morphine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3640....................... Radioimmunoassay, PVG.............. DOE.............. Exemption is limited
Morphine (123- to test systems
I), Goat intended for
Antibody employment and
Ammonium Sulfate insurance testing
Sep.. that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3640....................... Fluorometry, PVG.............. DJJ.............. Exemption is limited
Morphine. to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3640....................... Liquid PVG.............. DPK.............. Exemption is limited
Chromatography, to test systems
Morphine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)

[[Page 31987]]

862.3640....................... Gas PVG.............. DMY.............. Exemption is limited
Chromatography, to test systems
Morphine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3640....................... Hemagglutination PVG.............. DLR.............. Exemption is limited
Inhibition, to test systems
Morphine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3640....................... Free Radical PVG.............. DOK.............. Exemption is limited
Assay, Morphine. to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3640....................... Radioimmunoassay, PVG.............. DIQ.............. Exemption is limited
Morphine (3-H), to test systems
Goat Antibody intended for
Ammonium Sulfate employment and
Sep.. insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3640....................... Radioimmunoassay, PVG.............. DNA.............. Exemption is limited
Morphine- to test systems
Barbiturate (125- intended for
I), Goat employment and
Antibody. insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3650....................... Enzyme PVH.............. DJG.............. Exemption is limited
Immunoassay, to test systems
Opiates. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3650....................... Gas PVH.............. DJF.............. Exemption is limited
Chromatography, to test systems
Opiates. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3650....................... Hemagglutination, PVH.............. DLT.............. Exemption is limited
Opiates. to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)

[[Page 31988]]

862.3650....................... Thin Layer PVH.............. LAI.............. Exemption is limited
Chromatography, to test systems
Opiates. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3650....................... Free Radical PVH.............. DKT.............. Exemption is limited
Assay, Opiates. to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3650....................... High Pressure PVH.............. LAH.............. Exemption is limited
Liquid to test systems
Chromatography, intended for
Opiates. employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3700....................... Enzyme PVI.............. JXN.............. Exemption is limited
Immunoassay, to test systems
Propoxyphene. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3700....................... Thin Layer PVI.............. DPN.............. Exemption is limited
Chromatography, to test systems
Propoxyphene. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3700....................... Gas PVI.............. LAJ.............. Exemption is limited
Chromatography, to test systems
Propoxyphene. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3700....................... High Pressure PVI.............. LAK.............. Exemption is limited
Liquid to test systems
Chromatography, intended for
Propoxyphene. employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3870....................... Enzyme PVJ.............. LDJ.............. Exemption is limited
Immunoassay, to test systems
Cannabinoids. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)

[[Page 31989]]

862.3870....................... Reagents, Test, PVJ.............. DKE.............. Exemption is limited
Tetrahydrocannab to test systems
inol. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3870....................... Radioimmunoassay, PVJ.............. LAT.............. Exemption is limited
Cannabinoid(S). to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3910....................... High Pressure PVK.............. LFI.............. Exemption is limited
Liquid to test systems
Chromatography, intended for
Tricyclic employment and
Antidepressant insurance testing
Drugs. that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3910....................... U.V. PVK.............. LFH.............. Exemption is limited
Spectrometry, to test systems
Tricyclic intended for
Antidepressant employment and
Drugs. insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3910....................... Thin Layer PVK.............. MLK.............. Exemption is limited
Chromatography, to test systems
Tricyclic intended for
Antidepressant employment and
Drugs. insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
866.5750....................... System, Test, PUW.............. DHB.............. Exemption is limited
Radioallergosorb to devices classified
ent (RAST) under 21 CFR 866.5750
Immunological. that are intended to
detect any of the
allergens included in
table 3 of this
document.
868.2385....................... Analyzer, PUG.............. MRQ.............. Exemption is limited
Nitrogen Dioxide. to standalone
nitrogen dioxide
analyzers and not
those that are
components of nitric
oxide delivery
systems intended to
monitor nitrogen
dioxide levels during
inhaled nitric oxide
therapy.
870.1330....................... Wire, Guide, PTL.............. DQX.............. Exemption is limited
Catheter. to accessory torque
devices that are
manually operated,
non-patient
contacting, and
intended to
manipulate non-
cerebral vascular
guide wires.
870.1650....................... Syringe, Balloon PTM.............. MAV.............. Exemption is limited
Inflation. to non-patient
contacting balloon
inflation syringes
intended only to
inflate/deflate
balloon catheters and
monitor pressure
within the balloon.
870.2770....................... Analyzer, Body PUH.............. MNW.............. Exemption is limited
Composition. to body composition
analyzers which are
not intended to
diagnose or treat any
medical condition.
870.4400....................... Reservoir, Blood, PTN.............. DTN.............. Exemption is limited
Cardiopulmonary to cardiopulmonary
Bypass. bypass blood
reservoirs that do
not contain defoamers
or blood filters.
874.1090....................... Tester, Auditory PTO.............. ETY.............. Exemption is limited
Impedance. to auditory impedance
testers that are in
compliance with FDA-
recognized consensus
standard ANSI S3.39.
874.1090....................... Tympanometer..... PTP.............. NAS.............. Exemption is limited
to tympanometers that
are in compliance
with FDA-recognized
consensus standard
ANSI S3.39.
876.1500....................... Endoscopic PTQ.............. FCC.............. Exemption is limited
Magnetic to endoscopic
Retriever. magnetic retrievers
intended for single
use.
876.1500....................... Scissors For PTR.............. KGD.............. Exemption is limited
Cystoscope. to sterile scissors
for cystoscope
intended for single
use.

[[Page 31990]]

876.1500....................... Endoscopic PTS.............. OCZ.............. Exemption is limited
Grasping/Cutting to disposable, non-
Instrument, Non- powered endoscopic
Powered. grasping/cutting
instruments intended
for single use.
876.5010....................... Catheter, PTT.............. GCA.............. Exemption is limited
Biliary, to surgical biliary
Surgical. catheters that do not
include a balloon
component.
876.5630....................... Catheter, PTU.............. FJS.............. Exemption is limited
Peritoneal, Long- to non-patient
Term Indwelling. contacting catheter
finger grips intended
for single use.
876.5630....................... Catheter, PTV.............. FKO.............. Exemption is limited
Peritoneal to non-patient
Dialysis, Single contacting catheter
Use. finger grips intended
for single use.
876.5630....................... System, PTW.............. FKX.............. Exemption is limited
Peritoneal, to continuous
Automatic ambulatory peritoneal
Delivery. dialysis (CAPD) belts
and catheter stands
that do not include
weigh scales.
878.4370....................... Drape, Surgical.. PUI.............. KKX.............. Exemption is limited
to surgical drapes
that do not include
an antimicrobial
agent.
878.4495....................... Suture, PTX.............. GAQ.............. Exemption is limited
Nonabsorbable, to steel monofilament
Steel, sutures that are
Monofilament And uncoated and do not
Multifilament, incorporate barbs.
Sterile.
882.1470....................... Computerized PTY.............. PKQ.............. Exemption is limited
Cognitive to computerized
Assessment Aid. cognitive assessment
aids that are not
intended for
diagnostic assessment
of specific diseases
or conditions and
rely on inputs from
visual cues, auditory
cues, and/or
functional use of the
hand.
884.1630....................... Colposcope (and PTZ.............. HEX.............. Exemption is limited
Colpomicroscope). to standard
colposcopes (and
colpomicroscopes)
that use only a white
light source, do not
use filters other
than a green filter,
do not include image
analysis software,
and are not
smartphone-based.
884.4530....................... Tenaculum, PUA.............. HDC.............. Exemption is limited
Uterine. to sterile uterine
tenaculum devices
that do not use
suction and are
intended for single
use.
884.6120....................... Accessory, PUB.............. MQG.............. Exemption is limited
Assisted to simple embryo
Reproduction. incubators with
temperature, gas, and
humidity control
only; syringe pumps;
collection tube
warmers; dish/plate/
microscope stage
warmers; and
controlled-rate
cryopreservation
freezers.
884.6130....................... Microtools, PUC.............. MQH.............. Exemption is limited
Assisted to assisted
Reproduction reproduction
(Pipettes). microtools (pipettes)
manufactured from
glass.
884.6160....................... Labware, Assisted PUD.............. MQK.............. Exemption is limited
Reproduction. to dishes and plates
that are intended for
general assisted
reproduction
technology
procedures.
886.1850....................... Biomicroscope, PUE.............. HJO.............. Exemption is limited
Slit-Lamp, AC- to slit-lamp, AC-
Powered. powered
biomicroscopes
intended only for the
visual examination of
the anterior segment
of the eye, are
classified as Group 1
per FDA-recognized
consensus standard
ANSI Z80.36, do not
provide any
quantitative output,
and are not intended
for screening or
automated diagnostic
indications.
886.3320....................... Ocular Peg....... PUF.............. MQU.............. Exemption is limited
to ocular pegs
supplied sterile.
----------------------------------------------------------------------------------------------------------------

In table 2, FDA included devices classified under Sec. 866.5750
(Radioallergosorbent (RAST) immunological test system). FDA does not
believe that all devices classified under this regulation meet the
exemption criteria from premarket notification requirements. The
devices listed in table 3 are also classified under Sec. 866.5750, but
this subset no longer requires premarket notification under section
510(k) of the FD&C Act, subject to the general limitations to the
exemptions found in Sec. 866.9. While the non-exempt devices
classified under Sec. 866.5750 will retain product code ``DHB'', these
devices listed in table 3 are reassigned product code ``PUW.''

Table 3--Class II Devices
[Sec. 866.5750--Radioallergosorbent (RAST) Immunological Test Systems]
------------------------------------------------------------------------
Source (taxonomical
Allergen code Allergen product name)
------------------------------------------------------------------------
Grass Pollens
------------------------------------------------------------------------
g1.................... Sweet vernal grass..... Anthoxanthum odoratum.
g3.................... Cocksfoot grass, Dactylis glomerata.
Orchard grass.
g4.................... Meadow fescue.......... Festuca elatior.
g5.................... Rye-grass (perennial Lolium perenne.
rye grass).
g7.................... Common reed (common Phragmites communis.
reed grass).
g8.................... Meadow grass, Kentucky Poa pratensis.
blue (June grass).

[[Page 31991]]

g9.................... Redtop, Bentgrass...... Agrostis stolonifera
Agrostis gigantea
(Agrostis alba).
g11................... Brome grass............ Bromus inermis.
g12................... Cultivated rye Secale cereale.
(cultivated rye grass).
g13................... Velvet grass........... Holcus lanatus.
g14................... Cultivated oat Avena sativa.
(cultivated oat grass).
g15................... Cultivated wheat Triticum aestivum
(cultivated wheat (Triticum spp.).
grass).
g16................... Meadow foxtail (meadow Alopecurus pratensis.
foxtail grass).
g17................... Bahia grass............ Paspalum notatum.
g24................... Wheat grass, Western... Agropyron smithii
(Elymus smithii).
g30................... Bluegrass, annual...... Poa annua.
g70................... Wild rye grass......... Elymus triticoides
Elymus condensatus.
g71................... Canary grass........... Phalaris arundinacea.
g201.................. Barley, cultivated..... Hordeum vulgare.
g202.................. Maize, corn (cultivated Zea mays.
corn).
g203.................. Salt grass............. Distichlis spicata.
g204.................. False oat-grass........ Arrhenatherum elatius.
g216.................. Cyn d 1................ Cynodon dactylon.
g701.................. Phl p 1.0102, Phl p Phleum pratense.
5.0101.
g702.................. Phl p 7.0101........... Phleum pratense.
g703.................. Phl p 12.0101.......... Phleum pratense.
------------------------------------------------------------------------
Weed Pollens
------------------------------------------------------------------------
w2.................... Western ragweed........ Ambrosia psilostachya.
w4.................... False ragweed.......... Ambrosia acanthicarpa
(Franseria
acanthicarpa).
w5.................... Wormwood............... Artemisia absinthium
Artemisia annua.
w6.................... Mugwort................ Artemisia vulgaris.
w7.................... Marguerite, ox-eye Chrysanthemum
daisy. leucanthemum.
w8.................... Dandelion.............. Taraxacum vulgare
Taraxacum officinale.
w9.................... Plantain (English), Plantago lanceolata.
Ribwort.
w10................... Goosefoot, lamb's Chenopodium album.
quarters.
w11................... Saltwort (prickly), Salsola kali
Russian thistle. (Salsola pestifer).
w12................... Goldenrod.............. Solidago virgaurea
(Solidago spp.)
w13................... Cocklebur, common...... Xanthium commune.
w14................... Common pigweed (rough Amaranthus retroflexus.
pigweed).
w15................... Scale, Lenscale........ Atriplex lentiformis.
w16................... Rough marsh elder...... Iva ciliate
Iva annua.
w17................... Firebush (Kochia)...... Kochia scoparia.
w18................... Sheep sorrel........... Rumex acetosella.
w19................... Wall pellitory......... Parietaria officinalis.
w20................... Nettle (Common stinging Urtica dioica.
nettle).
w21................... Wall pellitory......... Parietaria judaica.
w22................... Japanese hop (careless Humulus japonicas
weed). (Humulus scandens).
w23................... Yellow dock, Yellow Rumex crispus.
dockweed.
w24................... Spiny pigweed.......... Amaranthus spinosus.
w27................... Carnation.............. Dianthus spp.
w28................... Rose................... Rosa rugosa.
w33................... Clover................. Trifolium pratense.
w35................... Mexican tea............ Chenopodium
ambrosioides.
w36................... Rabbit bush............ Ambrosia deltoidea
(Franseria deltoides).
w37................... Salt bush, annual...... Atriplex wrightii.
w39................... Water hemp, Western.... Amaranthus rudis
(Acnida tamariscina).
w41................... Burrobrush............. Hymenoclea salsola.
w42................... Poverty weed...........
w43................... Common sagebrush....... Artemisia tridentata.
w45................... Alfalfa................ Medicago sativa.
w46................... Dog fennel............. Eupatorium
capillifolium.

[[Page 31992]]

w53................... Geranium............... Geranium spp.
w67................... Groundsel bush......... Baccharis halimifolia.
w69................... Iodine bush............ Allenrolfea
occidentalis.
w70................... Ragweed, slender....... Ambrosia confertiflora.
w75................... Wing scale (wingscale). Atriplex canescens.
w82................... Careless weed.......... Amaranthus palmeri
Amaranthus hybridus.
w90................... Japanese hop........... Humulus japonicas
(Humulus scandens).
w203.................. Rape (rape pollen)..... Brassica napus.
w204.................. Sunflower.............. Helianthus annuus.
w206.................. Camomile............... Matricaria chamomilla.
w207.................. Lupin.................. Lupinus spp.
w210.................. Sugar-beet............. Beta vulgaris.
w211.................. Par j 2.0101........... Parietaria judaica.
w231.................. Art v 1................ Artemisia vulgaris
(Mugwort).
w232.................. Sal k 1................ Salsola kali.
w233.................. Art v 3................ Artemisa vulgaris (LTP,
Mugwort).
w234.................. Pla l 1................ Plantago lanceolata.
w235.................. Che a 1.0101........... Chenopodium album.
w236.................. Mer a 1.0101........... Mercurialis annua.
a753.................. Art v 1................ Artemisia vulgaris
(Mugwort weed).
------------------------------------------------------------------------
Tree Pollens
------------------------------------------------------------------------
t1.................... Box-elder (Maple)...... Acer negundo.
Acer saccharum.
t2.................... Gray alder, speckled Alnus incana.
alder (alder).
t4.................... Hazel, hazelnut........ Corylus avellana.
Corylus americana.
t5.................... American beech (beech). Fagus grandifolia.
(Fagus americana).
t6.................... Mountain juniper, Juniperus ashei
Mountain cedar. (Juniperus sabinoides).
t8.................... Elm.................... Ulmus americana.
t9.................... Olive.................. Olea europaea.
t10................... Walnut................. Juglans californica
Juglans nigra.
t11................... Maple leaf sycamore, Platanus acerifolia.
London plane, Plane
tree.
t61................... Sycamore............... Platanus occidentalis.
t12................... Willow................. Salix caprea
Salix nigra.
t14................... Cottonwood (Eastern Populus deltoides.
Cottonwood/Black
Cottonwood).
t15................... White ash.............. Fraxinus americana.
t16................... White pine............. Pinus strobus.
t18................... Eucalyptus, gum-tree... Eucalyptus globulus.
(Eucalyptus spp.).
t19/t26............... Acacia................. Acacia longifolia
(Acacia spp.).
t20................... Mesquite............... Prosopis glandulosa/
Prosopis juliflora.
t21................... Melaleuca, cajeput tree Melaleuca quinquenervia
(Melaleuca
leucadendron).
t22................... Pecan, hickory......... Carya illinoinensis
(Carya pecan).
t23................... Italian/Mediterranean/ Cupressus sempervirens.
funeral cypress.
t24................... Japanese cypress....... Chamaecyparis obtusa
(Chamaecyparis spp.).
t25................... Ash.................... Fraxinus excelsior.
t27................... Maple, red............. Acer rubrum.
t29................... Acacia................. Acacia spp.
t30................... Birch, white........... Betula populifolia.
t32................... Willow, black.......... Salix nigra.
t33................... Ash, Arizona........... Fraxinus velutina.
t35................... Cedar, salt............ Tamarix gallica.
t37................... Bald cypress (white Taxodium distichum.
bald cypress).
t38................... Elm, Chinese/Siberian.. Ulmus pumila.
t40................... Hazelnut tree.......... Corylus americana.
t41................... White hickory.......... Carya alba
(Carya tomentosa).
t42................... Oak, red............... Quercus rubra.
t43................... Loblolly pine.......... Pinus taeda.
t44................... Hackberry.............. Celtis occidentalis.

[[Page 31993]]

t45................... Cedar elm.............. Ulmus crassifolia.
t47................... Juniper, one seed...... Juniperus monosperma.
t48................... Pine, lodgepole........ Pinus contorta.
t49................... Pine, ponderosa........ Pinus ponderosa.
t50................... Beech, European........ Fagus sylvatica.
t51................... Tree of Heaven......... Ailanthus altissima.
t52................... Western white pine..... Pinus monticola.
t54................... Russian olive.......... Elaeagnus angustifolia.
t55................... Scotch broom........... Cytisus scoparius.
t56................... Bayberry............... Myrica cerifera.
t57................... Red cedar.............. Juniperus virginiana.
t60................... Western juniper........ Juniperus occidentalis.
t61................... Sycamore............... Platanus occidentalis.
t70................... Mulberry (white Morus alba.
mulberry).
t71................... Red mulberry........... Morus rubra.
t72................... Queen palm............. Arecastrum
romanzoffiamon.
t73................... Australian pine........ Casuarina
equisetifolia.
t77................... Oak mix (red, white, Quercus spp.
black).
t80................... Japanese cypress....... Chamaecyparis obtusa.
t81................... Japanese alder......... Alnus japonica.
t83................... Mango tree............. Mangifera indica.
t90................... Walnut, black.......... Juglans nigra.
t96................... Poplar, white (poplar). Populus alba.
t103/................. Virginia live oak (live Quercus virginiana.
t218.................. oak).
t105.................. Pepper tree............ Schinus molle.
t110.................. Orange tree............ Citrus sinensis.
t201.................. Spruce, Norway spruce.. Picea abies (Picea
excelsa).
t202.................. Alder, smooth.......... Alnus incana spp.
Rugosa
(Alnus rugosa).
t203.................. Horse chestnut......... Aesculus hippocastanum.
t205.................. Elder.................. Sambucus nigra.
t206.................. Chestnut............... Castanea sativa.
t207.................. Douglas fir............ Pseudotsuga menziesii
(Pseudotsuga
taxifolia).
t208.................. Linden................. Tilia cordata.
t209.................. Horn beam.............. Carpinus betulus.
t210.................. Privet................. Ligustrum vulgare.
t211.................. Sweet gum.............. Liquidambar
styraciflua.
t212.................. Cedar.................. Libocedrus decurrens.
t213.................. Pine................... Pinus radiata.
t214.................. Date palm.............. Phoenix canariensis.
t215.................. Lilac.................. Syringa vulgaris.
t217.................. Pepper tree............ Schinus molle.
t217.................. Red alder.............. Alnus rubra.
t218.................. Virginia live oak...... Quercus virginiana.
t218.................. Bayberry (bayberry/ Myrica gale.
sweet gale).
t219.................. Palo verde............. Cercidium floridum.
t219.................. Red cedar.............. Juniperus virginiana.
t220.................. Bet v 4................ Betula verrucosa
(Birch).
t221.................. Bet v 2.0101, Bet v 4.. Betula verrucosa
(Birch).
t222.................. Cypress (Arizona Cupressus arizonica.
cypress).
t223.................. Oil palm............... Elaeis guineensis.
t224.................. Ole e 1................ Olea europaea.
t225.................. Bet v 6................ Betula verrucosa
(Birch).
t226.................. Cup a 1................ Cupressus arizonica.
t227.................. Ole e 7................ Olea Europaea.
t228.................. Aspen, quaking......... Populus tremuloides.
t229.................. Eastern hemlock........ Tsuga canadensis.
t230.................. Redwood (sequoia)...... Sequoia sempervirens.
t232.................. Pussy willow........... Salix discolor.
t240.................. Ole e 9.0101........... Olea Europaea.
t241.................. Pla a 1.0101........... Platanus acerifolia.
t242.................. Pla a 2................ Platanus acerifolia.
t243.................. Pla a 3.0101........... Platanus acerifolia.
t244.................. Cor a 1.0103........... Corylus avellana.
t245.................. Aln g 1.0101........... Alnus glutinosa.
t246.................. Cry j 1................ Cryptomeria japonica.
t280.................. Locust tree............ Robinia pseudoacacia.
t401.................. Brazilian peppertree... Schinus
terebinthifolius.
t402.................. Mastic tree............ Pistacia lentiscus.

[[Page 31994]]

t404.................. Tree of heaven......... Ailanthus altissima.
t406.................. Date palm.............. Phoenix dactylifera.
a482.................. Ole e 1................ Olea europaea (Olive
Oil).
------------------------------------------------------------------------
Mites
------------------------------------------------------------------------
d207.................. Blo t 5.0101........... Blomia tropicalis.
d208.................. Lep d 2.0101........... Lepidoglyphus
destructor.
------------------------------------------------------------------------
Microorganisms, Molds, Yeast
------------------------------------------------------------------------
m1.................... Penicillium chrysogenum Penicillium chrysogenum
(Penicillium notatum).. (Penicillium notatum).
m2.................... Cladosporium herbarum Cladosporium herbarum
(Hormodendrum). (Hormodendrum).
m3.................... Aspergillus fumigatus.. Aspergillus fumigatus.
m4.................... Mucor racemosus........ Mucor racemosus.
m5.................... Candida albicans....... Candida albicans.
m7.................... Botrytis cinerea....... Botrytis cinerea.
m8.................... Drechslera halodes Drechslera halodes
(Setomelanomma (Setomelanomma
rostrata, rostrata,
Helminthosporium Helminthosporium
halodes, halodes).
Helminthosporium
interseminatum).
m9.................... Fusarium moniliforme Fusarium moniliforme
(Fusarium (Fusarium
proliferatum). proliferatum).
m10................... Stemphylium botryosum.. Stemphylium herbarum
(Stemphylium
botryosum).
m11................... Rhizopus nigricans..... Rhizopus nigricans.
m12................... Aureobasidium pullulans Aureobasidium
pullulans.
m13................... Phoma betae............ Phoma betae.
m14................... Epicoccum purpurascens. Epicoccum purpurascens
(Epicoccum nigrum).
m15................... Trichoderma viride..... Trichoderma viride.
m16................... Curvularia lunata...... Curvularia lunata
Curvularia specifera
(K923044).
m17................... Cladosporium fulvum.... Cladosporium fulvum.
m18................... Fusarium culmorum...... Fusarium culmorum.
m19................... Aspergillus versicolor. Aspergillus versicolor.
m20................... Mucor mucedo........... Mucor mucedo.
m21................... Aspergillus clavatus... Aspergillus clavatus.
m22................... Micropolyspora faeni... Saccharopolyspora
rectivirgula
(Micropolyspora
faeni).
m23................... Thermoactinomyces Thermoactinomyces
vulgaris. vulgaris.
m24................... Stachybotrys atra...... Stachybotrys chartarum
(Stachybotrys atra).
m24................... Paecilomyces spp....... Paecilomyces spp.
m25................... Aspergillus versicolor. Aspergillus versicolor.
m25................... Penicillium Penicillium
brevicompactum. brevicompactum.
m26................... Cladosporium Cladosporium
cladosporioides. cladosporioides.
m26................... Penicillium citrinum... Penicillium citrinum.
m27................... Penicillium spp........ Penicillium spp.
m29................... Aspergillus repens..... Aspergillus repens.
m30................... Penicillium roqueforti. Penicillium roqueforti.
m32................... Cladosporium Cladosporium
cladosporioides. cladosporioides.
m34................... Serpula lacrymans...... Serpula lacrymans.
m36................... Aspergillus terreus.... Aspergillus terreus.
m37................... Trichophyton Trichophyton
mentagrophytes. mentagrophytes.
m40................... Aspergillus amstelodami Aspergillus
amstelodami.
m43................... Saccharomyces carlsberg Saccharomyces
carlsbergensis.
m44................... Saccharomyces Saccharomyces
cerevisiae. cerevisiae.
m45................... Hormodendrum hordei.... Hormodendrum hordei.
m46................... Bipolaris spicifera.... Bipolaris spicifera.
m47................... Aspergillus nidulans... Aspergillus nidulans.
m48................... Aspergillus oryzae..... Aspergillus oryzae.
m49................... Fusarium oxysporum..... Fusarium oxysporum.
m50................... Micropolyspora faeni... Saccharopolyspora
rectivirgula
(Micropolyspora
faeni).
m51................... Thermoactinomyces Thermoactinomyces
vulgaris. vulgaris.
m53................... Microspora canis....... Microsporum canis
(Microspora canis).
m54................... Aspergillus flavus..... Aspergillus flavus.
m63................... Helminthosporium Helminthosporium
intersemin. intersemin.
m66................... Mucor plumbeus......... Mucor plumbeus.
m67................... Mycogone............... Mycogone perniciosa.
m68................... Nigrospora oryzae...... Nigrospora oryzae.

[[Page 31995]]

m69................... Rhodotorula............ Rhodotorula rubra
(Rhodotorula
mucilaginosa).
m70................... Malassezia furfur Malassezia furfur
(Pityrosporum (Pityrosporum
orbiculare). orbiculare).
m71................... Spondylocladium........ Spondylocladium spp.
m72................... Epidermophyton......... Epidermophyton
floccosum.
m73................... Epicoccum nigrum....... Epicoccum purpurascens
(Epicoccum nigrum).
m80................... Staphylococcal Staphylococcus aureus.
enterotoxin A (Sta a
SEA).
m80................... Helminthosporium spp... Helminthosporium spp.
m81................... Staphylococcal Staphylococcus aureus.
enterotoxin B (Sta a
SEB).
m88................... Stemphylium solani..... Stemphylium solani.
m93................... Gliocladium fimbriatum. Gliocladium fimbriatum.
m94................... Phycomyces Phycomyces
blakesleeanus. blakesleeanus.
m201.................. Tilletia tritici Tilletia tritici
(Ustilago nuda, (Ustilago nuda,
Ustilago tritici) Ustilago tritici).
(Barley smut).
m202.................. Acremonium kiliense Acremonium kiliense
(Cephalosporium (Cephalosporium
acremonium). acremonium).
m203.................. Trichosporon pullulans. Trichosporon pullulans.
m204.................. Ulocladium chartarum... Ulocladium chartarum.
m205.................. Trichophyton rubrum.... Trichophyton rubrum.
m207.................. Aspergillus niger...... Aspergillus niger.
m208.................. Chaetomium globosum.... Chaetomium globosum.
m209.................. Penicillium frequentans Penicillium glabrum
(Penicillium
frequentans).
m209.................. Stachybotrys chartarum. Stachybotrys chartarum
(Stachybotrys atra).
m210.................. Trichophyton Trichophyton
mentagrophytes var. mentagrophytes var.
goetzii. goetzii.
m211.................. Trichophyton Trichophyton
mentagrophytes var. mentagrophytes var.
interdigitale. interdigitale.
m211.................. Oat smut............... Ustilago avenae.
m212.................. Micropolyspora faeni... Saccharopolyspora
rectivirgula
(Micropolyspora
faeni).
m212.................. Geotrichum candidum.... Geotrichum candidum.
m213.................. Bermuda grass smut..... Ustilago cynodontis.
m214.................. Johnson grass smut..... Sphacelotheca cruenta.
m215.................. Corn smut.............. Ustilago maydis.
m218.................. Asp f 1.0101........... Aspergillus fumigatus.
a3050................. Asp r 1................ Aspergillus restrictus.
m219.................. Asp f 2................ Aspergillus fumigatus.
m220.................. Asp f 3.0101........... Aspergillus fumigatus.
m221.................. Asp f 4................ Aspergillus fumigatus.
m222.................. Asp f 6.0101........... Aspergillus fumigatus.
m223.................. Staphylococal Staphylococus aureus.
enterotoxin C (Sta a
SEC).
m224.................. Staphylococcal Staphylococcus aureus.
enterotoxin D (Sta a
SED).
m226.................. Staphylococcal Staphylococcus aureus.
enterotoxin TSST (Sta
a TSST).
m227.................. Malassezia spp. Malassezia spp.
(Pityrosporum spp.). (Pityrosporum spp.).
m228.................. Aspergillus flavus.....
m229.................. Alt a 1.0101........... Alternaria alternata
(Alternaria tenuis).
m230.................. Alt a 6.0101........... Alternaria alternata
(Alternaria tenuis).
m231.................. Cla h 8.0101........... Cladosporium herbarum
(Hormodendrum).
m300.................. Eurotium spp........... Eurotium spp.
m304.................. Aspergillus oryzae..... Aspergillus oryzae.
m305.................. Penicillium Penicillium
brevicompactum. brevicompactum.
m309.................. Aspergillus terreus.... Aspergillus terreus.
m310.................. Aspergillus nidulans... Aspergillus nidulans.
m311.................. Aspergillus flavus..... Aspergillus flavus.
m312.................. Aspergillus clavatus... Aspergillus clavatus.
------------------------------------------------------------------------
Epidermal & Animal
------------------------------------------------------------------------
e6.................... Guinea pig epithelium.. Cavia porcellus.
e7.................... Pigeon droppings....... Columba palumbus
Columba livia.
e25................... Chicken serum.......... Gallus domesticus
(Gallus gallus
domesticus; Gallus
spp.).
e26................... Parrot serum........... Psittacoidea spp.
e62................... Camel.................. Camelus dromedaries.
e70................... Goose feathers......... Anser anser.
e71................... Mouse epithelium....... Mus musculus
(Mus spp.).
e73................... Rat epithelium......... Rattus norvegicus.
e74................... Rat urine proteins..... Rattus norvegicus
Rattus rattus.

[[Page 31996]]

e75................... Rat serum proteins..... Rattus norvegicus
Rattus rattus.
e76................... Mouse serum proteins... Mus musculus
(Mus spp.).
e77................... Budgerigar droppings... Melopsittacus
undulatus.
e78................... Budgerigar feathers.... Melopsittacus
undulatus.
e79................... Budgerigar serum Melopsittacus
proteins. undulatus.
e80................... Goat epithelium........ Capra hircus.
e81................... Sheep epithelium....... Ovis aries
(Ovis spp.).
e82................... Rabbit epithelium...... Oryctolagus cuniculus
(Oryctolagus spp.).
e83................... Swine epithelium....... Sus scrofa
(Sus scrofa domesticus;
Sus spp.).
e84................... Hamster epithelium..... Cricetus cricetus,
Mesocricetus auratus,
and Phodopus sungorus.
e85................... Chicken feathers....... Gallus domesticus
(Gallus gallus
domesticus; Gallus
spp.).
e86................... Duck feathers.......... Anas platyrhynchos.
e87................... Rat epithelium, serum Rattus norvegicus
proteins, and urine Rattus rattus.
proteins.
e88................... Mouse epithelium, serum Mus musculus (Mus
proteins, and urine spp.).
proteins (mouse).
e89................... Turkey feathers........ Meleagris gallopavo.
e90................... Budgerigar serum Melopsittacus
proteins, feathers, undulatus.
and droppings.
e91................... Pigeon serum proteins, Streptopelia
feathers, and roseogrisea
droppings. Psittacidae spp.
e92................... Parrot serum proteins, Ara spp.
feathers, and
droppings.
e93................... Pigeon serum proteins.. Streptopelia
roseogrisea.
e94................... Fel d 1.0101........... Felis domesticus.
a345.................. Fel d 1................ Felis domesticus.
e98................... Parrot droppings....... Psittacoidea spp.
e101.................. Can f 1.0101........... Canis familiaris (Canis
domesticus).
a174.................. Can f 1................ Canis familiaris (Canis
domesticus).
e102.................. Can f 2.0101........... Canis familiaris (Canis
domesticus).
e196.................. Parakeet feathers...... Nymphicus hollandicus.
e197.................. Parakeet droppings..... Nymphicus hollandicus.
e198.................. Parakeet serum......... Nymphicus hollandicus.
e199.................. Canary bird serum...... Serinus canarius.
e200.................. Canary bird droppings.. Serinus canarius.
e201.................. Canary bird feathers Serinus canarius.
(Canary feathers).
e202.................. Reindeer epithelium.... Rangifer tarandus.
e203.................. Mink epithelium........ Mustela spp.
e204.................. Bos d 6................ Bos domesticus (Bos
taurus; Bos spp.).
e205.................. Horse, serum proteins.. Equus caballus (Equus
spp.).
e206.................. Rabbit, serum proteins. Oryctolagus cuniculus
(Oryctolagus spp.).
e208.................. Chinchilla epithelium.. Chinchilla laniger.
e209.................. Gerbil epithelium...... Meriones unguiculatus.
e210.................. Fox epithelium......... Vulpes vulpes.
e211.................. Rabbit, urine proteins. Oryctolagus cuniculus
(Oryctolagus spp.).
e212.................. Swine, urine proteins.. Sus scrofa
(Sus scrofa domesticus;
Sus spp.).
e213.................. Parrot feathers........ Ara spp.
e214.................. Finch feathers......... Lonchura domestica.
e215.................. Pigeon feathers........ Streptopelia
roseogrisea
(Streptopelia spp.)
Columbia spp.
e216.................. Deer epithelium........ Dama dama.
e217.................. Ferret epithelium...... Mustela putorius.
e218.................. Chicken droppings...... Gallus domesticus
(Gallus gallus
domesticus; Gallus
spp.).
e219.................. Chicken, serum proteins Gallus domesticus
(Gallus gallus
domesticus; Gallus
spp.).
e220.................. Fel d 2, Cat serum Felis domesticus.
albumin.
e221.................. Can f 3................ Canis familiaris (Canis
domesticus)
(Dog serum albumin).
e222.................. Swine serum albumin Sus scrofa (Sus scrofa
(Sus s PSA). domesticus; Sus spp.).
e225.................. Lovebird feathers...... Psittacoidea agapomis.
e226.................. Can f 5.0101........... Canis familiaris.
e227.................. Equ c 1.0101........... Equus caballus.
e228.................. Fel d 4.0101........... Felis domesticus.
e230.................. Equ c 3................ Equus caballus.

[[Page 31997]]

e231.................. Mus m 1................ Mus musculus.
------------------------------------------------------------------------
Food
------------------------------------------------------------------------
f9.................... Rice................... Oryza sativa.
f12................... Pea (green pea)........ Pisum sativum.
f15................... White bean............. Phaseolus vulgaris.
f19................... Cayenne pepper......... Capsicum frutescens
(Capsicum annum).
f21................... Sugar cane............. Saccharum officinarum.
f22................... Raspberry.............. Rubus idaeus.
f26................... Pork................... Sus scrofa (Sus scrofa
domesticus; Sus spp.).
f29................... Watermelon............. Citrullus lanatus
(Citrullus vulgaris).
f31................... Carrot................. Daucus carota.
f32................... Oyster mushroom........ Pleurotus ostreatus.
f33................... Orange................. Citrus sinensis.
f35................... Potato................. Solanum tuberosum.
f43................... Mother's milk.......... Homo sapiens.
f44................... Strawberry............. Fragaria vesca
(Fragaria spp.).
f45................... Yeast, baker's......... Saccharomyces
cerevisiae.
f46................... Pepper, Red............ Capsicum annuum.
f47................... Garlic................. Allium sativum.
f48................... Onion.................. Allium cepa.
f49................... Apple.................. Malus x domestica
(Malus spp.).
f51................... Bamboo shoot........... Phyllostachys
pubescens.
f52................... Cacao/chocolate........ Theobroma cacao.
f54................... Sweet potato........... Ipomoea batatas.
f55................... Common millet.......... Panicum miliaceum.
f56................... Foxtail millet......... Setaria italica.
f57................... Japanese millet........ Echinochloa crus-galli.
f58................... Pacific squid.......... Todarodes pacificus.
f59................... Octopus................ Octopus vulgaris
(Octopus spp.).
f63................... Kefir.................. NA.
f67................... Parmesan cheese........ NA.
f81................... Cheese, cheddar type... NA.
f82................... Cheese, mold type...... NA.
f83................... Chicken................ Gallus domesticus
(Gallus gallus
domesticus; Gallus
spp.).
f86................... Parsley................ Petroselinum crispum.
f87................... Melon.................. Cucumis melo Cucumis
melo + Citrullus
lanatus.
f88................... Mutton (lamb).......... Ovis aries (Ovis spp.).
f90................... Malt................... Hordeum vulgare.
f92................... Banana................. Musa spp.
f93................... Cacao.................. Theobroma cacao.
f94................... Pear................... Pyrus communis (Pyrus
spp.).
f97................... Yam.................... Dioscorea spp.
Dioscorea opposita.
f97................... Chamomile tea.......... Matricaria chamomilla.
f98................... Gliadin................ Triticum aestivum
(Triticum spp.).
f102.................. Cantaloupe............. Cucumis melo var.
cantalupensis.
f105.................. Chocolate.............. Theobroma cacao.
f109.................. Cottonseed............. Gossypium hirsutum.
f110.................. Giant radish........... Raphanus sativus.
f118.................. Zucchini............... Cucurbita pepo.
f119.................. Radish................. Raphanus sativus.
f120.................. Venison................ Capreolus capeolus.
f121.................. Pinto bean............. Phaseolus vulgaris.
f122.................. Cheese, American....... NA.
f127.................. Black-eyed pea......... Vigna unguiculata.
f131.................. Black Olive............ Olea europaea.
f136.................. Red beet............... Beta vulgaris var.
conditiva.
f139.................. Goat's Cheese.......... Capra aegagrus.
f140.................. Bran................... NA.
f141.................. Corn (vegetables)...... Zea mays.
f152.................. Green bell pepper...... Capsicum annuum.
f155.................. Brewer's yeast......... Saccharomyces
carlsbergensis.
f157.................. Duck................... Anas domesticus.
f158.................. Goose.................. Anser anser.
f160.................. Camembert cheese....... NA.

[[Page 31998]]

f162.................. Nectarine.............. Prunus persica var.
nucipersica.
f163.................. Kohlrabi............... Brassica oleracea var.
gongylodes.
f65................... Perch..................
f166.................. Leek................... Allium porrum.
f170.................. Cheese (Switzerland) NA.
(Swiss cheese).
f174.................. Fig.................... Ficus carica.
f177.................. Cranberry.............. Vaccinium macrocarpon.
f179.................. Raisin................. Vitis spp.
f182.................. Lima bean.............. Phaseolus lunatus.
f198.................. Flaxseed (bruised Linum usitatissimum.
grain).
f199.................. Untreated native milk.. Bos domesticus (Bos
taurus; Bos spp.).
f208.................. Lemon.................. Citrus limon.
f209.................. Grapefruit............. Citrus paradisi.
f210.................. Pineapple.............. Ananas comosus.
f211.................. Blackberry............. Rubus fruticosus.
f212.................. Mushroom (champignon).. Agaricus hortensis
(Agaricus spp.).
f213.................. Rabbit................. Oryctolagus cuniculus
(Oryctolagus spp.).
f214.................. Spinach................ Spinacia oleracea.
f215.................. Lettuce................ Lactuca sativa.
f216.................. Cabbage................ Brassica oleracea var.
capitata.
f217.................. Brussels sprouts....... Brassica oleracea var.
gem.
f218.................. Paprika, sweet pepper.. Capsicum annuum.
f219.................. Fennel seed............ Foeniculum vulgare.
f219.................. Sage................... Salvia officinalis.
f220.................. Cinnamon............... Cinnamomum spp.
f221.................. Coffee................. Coffea spp.
f222.................. Tea.................... Camellia sinensis.
f223.................. Green olive............ Olea europaea.
f225.................. Summer squash, pumpkin. Cucurbita pepo.
f225.................. Pumpkin................ Cucurbita maxima.
f226.................. Pumpkin seed........... Cucurbita pepo.
f227.................. Sugar-beet seed........ Beta vulgaris.
f229.................. Safflower Seed......... Carthamus tinctorius.
f231.................. Milk, boiled........... Bos domesticus
(Bos taurus; Bos spp.).
f234.................. Vanilla................ Vanilla planifolia.
f237.................. Apricot................ Prunus armeniaca.
f241.................. Gouda cheese........... NA.
f242.................. Cherry................. Prunus avium.
f244.................. Cucumber............... Cucumis sativus.
f246.................. Guar, guar gum......... Cyamopsis
tetragonoloba.
f247.................. Honey.................. NA.
f248.................. Rosemary............... Rosmarinus officinalis.
f254.................. Plaice................. Pleuronectes platessa.
f255.................. Plum................... Prunus domestica
Prunus americana.
f258.................. Squid.................. Loligo spp.
f259.................. Grape.................. Vitis vinifera
(Vitis spp.).
f260.................. Broccoli............... Brassica oleracea var.
italica (Brassica
oleracea var.
cultivar).
f261.................. Asparagus.............. Asparagus officinalis.
f262.................. Aubergine, eggplant.... Solanum melongena.
f263.................. Green pepper........... Piper nigrum
Capsicum annuum.
f264.................. Eel.................... Anguilla anguilla.
f265.................. Caraway................ Carum carvi.
f265.................. Cumin.................. Cuminum cyminum.
f266.................. Mace................... Myristica fragrans.
f267.................. Cardamon............... Elettaria cardamomum.
f268.................. Clove.................. Syzygium aromaticum.
f269.................. Basil.................. Ocimum basilicum.
f270.................. Ginger................. Zingiber officinale.
f271.................. Anise.................. Pimpinella anisum.
f272.................. Tarragon............... Artemisia dracunculus.
f273.................. Thyme.................. Thymus vulgaris.
f274.................. Marjoram............... Origanum majorana.
f275.................. Lovage................. Levisticum officinale.
f276.................. Fennel, fresh.......... Foeniculum vulgare.

[[Page 31999]]

f277.................. Dill................... Anethum graveolens.
f278.................. Bay leaf............... Laurus nobilis.
f279.................. Chili pepper........... Capsicum frutescens.
f280.................. Black pepper........... Piper nigrum.
f281.................. Curry (Santa Maria).... NA.
f282.................. Nutmeg................. Myristica fragrans.
f283.................. Oregano................ Origanum vulgare.
f284.................. Turkey meat............ Meleagris gallopavo.
f285.................. Elk/moose meat......... Alces spp.
f286.................. Mare's milk............ Equus caballus (Equus
spp.).
f287.................. Red kidney bean........ Phaseolus vulgaris.
f288.................. Blueberry.............. Vaccinium myrtillus
(Vaccinium spp.).
f289.................. Date................... Phoenix dactylifera.
f291.................. Cauliflower............ Brassica oleracea var.
botrytis.
f292.................. Guava.................. Psidium guajava.
f293.................. Papaya................. Carica papaya.
f294.................. Passion fruit, Maracuja Passiflora edulis
(Passiflora spp.).
f295.................. Carambola.............. Averrhoa carambola.
f296.................. Carob.................. Ceratonia siliqua.
f297.................. Gum arabic............. Acacia senegal (Acacia
spp.).
f298.................. Tragacanth............. Astragalus spp.
f299.................. Sweet chestnut Castanea sativa.
(chestnut).
f300.................. Pinto bean............. Phaseolus spp.
f301.................. Persimmon (kaki fruit, Diospyros kaki.
sharon).
f302.................. Mandarin (tangerine, Citrus reticulata.
clementine, satsumas).
f305.................. Fenugreek.............. Trigonella foenum-
graecum.
f306.................. Lime................... Citrus aurantifolia.
f307.................. Hake................... Merluccius merluccius.
f308.................. Sardine (pilchard)..... Sardina pilchardus.
f310.................. Blue vetch............. Lathyrus sativus.
f311.................. Megrim................. Lepidorhombus
whiffiagonis.
f315.................. Green bean............. Phaseolus vulgaris.
f316.................. Rape seed.............. Brassica napus.
f317.................. Coriander.............. Coriandrum sativum.
f318.................. Jack fruit............. Artocarpus
heterophyllus.
f319.................. Beetroot............... Beta vulgaris.
f320.................. Crayfish............... Astacus astacus.
f321.................. Horse meat............. Equus caballus (Equus
spp.).
f322.................. Red currant............ Ribes sylvestre.
f324.................. Hop (fruit cone)....... Humulus lupulus.
f325.................. Saffron................ Colchicum autumnale.
f328.................. Fig.................... Ficus carica.
f329.................. Watermelon............. Citrullus lanatus.
f330.................. Rose hip............... Rosa spp.
f331.................. Saffron................ Crocus sativus.
f332.................. Mint................... Mentha piperita.
f333.................. Linseed................ Linum usitatissimum.
f336.................. Jujube................. Ziziphus jujuba.
f336.................. Wine vinegar........... Vitis vinifera (Vitis
spp.).
f337.................. Sole................... Solea solea.
f337.................. English sole........... Parophrys vetulus.
f338.................. Wine, white............ Vitis vinifera (Vitis
spp.).
f339.................. Allspice............... Pimenta dioica.
f339.................. Wine, red.............. Vitis vinifera (Vitis
spp.).
f341.................. Cranberry.............. Vaccinium oxycoccus
Vaccinium macrocarpon.
f342.................. Olive (black, fresh)... Olea europaea.
f343.................. Raspberry.............. Rubus idaeus.
f344.................. Sage................... Salvia officinalis.
f346.................. Chives................. Allium schoenoprasum.
f347.................. Quinoa................. Chenopodium quinoa.
f348.................. Litchi................. Litchi chinensis.
f349.................. Chum salmon roe........ Oncorhynchus keta.
f358.................. Artichoke.............. Cynara scolymus.
f360.................. Yogurt................. NA.
f368.................. Black bass............. Micropterus dolomieu
(Micropterus
dolomieui).
f374.................. Karaya gum............. Sterculia urens.
f375.................. Horseradish............ Armoracia rusticana.
f377.................. Maple syrup............ NA.
f379.................. Okra................... Abelmoschus esculentus.

[[Page 32000]]

f382.................. Beet, sugar............ Beta vulgaris var.
altissima.
f401.................. Loquat................. Eriobotrya japonica.
f402.................. Fig.................... Ficus carica.
f403.................. Brewer's yeast......... Saccharomyces
cerevisiae.
f405.................. Mint................... Mentha spp.
f406.................. Arugula................ Eruca vesicaria.
------------------------------------------------------------------------
House Dust
------------------------------------------------------------------------
h1.................... Greer Labs., Inc....... NA.
h2.................... Hollister-Stier Labs... NA.
h6.................... Japan.................. NA.
------------------------------------------------------------------------
Venoms & Insects
------------------------------------------------------------------------
i7.................... Midge.................. Chironomus yoshimatsui.
i8.................... Moth................... Bombyx mori
Heterocera spp.
i47................... Water flea............. Daphnia spp.
i49................... Deer fly............... Chrysops spp.
i51................... Black ant.............. Camponotus
pennsylvanicus.
i54................... Flea mix (dog/cat), Ctenocephalides spp.
common flea.
i71................... Mosquito............... Aedes communis
Aedes spp. and Culex
spp.
i72................... Green nimitti.......... Cladotanytarsus lewisi.
i73................... Blood worm............. Chironomus thummi
Chironomusri parius
Chironomus spp.
i75................... European hornet........ Vespa crabro.
i76................... Berlin beetle.......... Trogoderma angustum.
i77................... European paper wasp.... Polistes dominulus.
i78................... Fly.................... Musca domestica.
i80................... Bumblebee.............. Bombus pennsylvanicus.
i201.................. Horse bot fly.......... Gasterophilus
intestinalis.
i202.................. Grain weevil........... Sitophilus granarius.
i203.................. Mediterranean flour Ephestia kuehniella
moth. (Anagasta kuehniella).
i204.................. Horse fly.............. Tabanus spp.
i205.................. Bumblebee.............. Bombus terrestris.
i208.................. Api m 1.0101........... Apis mellifera.
a45................... Api m 1................ Apis mellifera.
i209.................. Ves v 5.0101........... Vespula vulgaris.
a670.................. Ves v 5................ Vespula vulgaris.
i210.................. Pol d 5.0101........... Polistes dominulus.
i211.................. Ves v 1.0101........... Vespula vulgaris.
i213.................. Api m 4................ Apis mellifera.
i214.................. Api m 2................ Apis mellifera.
i215.................. Api m 3................ Apis mellifera.
i216.................. Api m 5................ Apis mellifera.
i217.................. Api m 10............... Apis mellifera.
i220.................. Bla g 1.0101........... Blattella germanica.
i221.................. Bla g 2.0101........... Blattella germanica.
i222.................. Bla g 5.0101........... Blattella germanica.
i223.................. Bla g 7................ Blattella germanica
a46................... Api m 2................ Apis mellifera.
------------------------------------------------------------------------
Miscellaneous
------------------------------------------------------------------------
o1.................... Cotton, crude fibers... Gossypium spp.
o3.................... Cotton (treated)....... Gossypium spp.
o70................... Seminal fluid.......... Homo sapiens.
o71................... Staphylococcus aureus.. Staphylococcus aureus.
o72................... Pichia pastoris crude Pichia pastoris.
extract customer
specific.
o72................... Sperm-sediment......... Homo sapiens.
o73................... Pichia pastoris crude Pichia pastoris.
extr. vector customer
specific.
o74................... Pichia pastoris with Pichia pastoris.
vector customer
specific.
o201.................. Tobacco leaf, tobacco Nicotiana tabacum.
dust.
o202.................. Artemia salina, fish Artemia salina.
feed.
o203.................. Tetramin, fish feed.... NA.
o207.................. Daphnia, fish feed..... Daphnia spp.
o211.................. Mealworm............... Tenebrio molitor.

[[Page 32001]]

o212.................. Streptavidin........... Streptomyces avidini.
o213.................. MBP (maltose binding Escherichia coli.
protein).
o214.................. CCD; MUXF3 from Ananas comosus.
bromelain.
o72................... Enterotoxin A (Sta a Staphylococcus aureus.
SEA).
o73................... Enterotoxin B (Sta a Staphylococcus aureus.
SEB).
------------------------------------------------------------------------
Parasites
------------------------------------------------------------------------
p1.................... Ascaris................ Ascaris suum.
p2.................... Echinococcus........... Echinococcus
granulosus.
p3.................... Schistosoma............ Schistosoma mansoni.
p4.................... Anisakis (Herring Worm) Anisakis simplex
(Anisakis spp.).
p5.................... Toxocara canis......... Toxocara canis.
p10................... Ani s 3.0101........... Anisakis simplex
(Anisakis spp.).
p11................... Ani s 1................ Anisakis simplex
(Anisakis spp.).
------------------------------------------------------------------------
Occupational
------------------------------------------------------------------------
k4.................... Threshing dust......... NA.
k5.................... Flax................... NA.
k7.................... Hay Dust............... NA.
k8.................... Hop (hops)............. Humulus lupulus.
k12................... Grain mill dust........ NA.
k14................... Kapok.................. NA.
k20................... Sheep's wool (treated) Ovis aries (Ovis spp.).
(wool).
k21................... Sheep's wool Ovis aries (Ovis spp.).
(Untreated).
k23................... Straw Dust............. NA.
k33................... Oak.................... NA.
k70................... Green coffee bean...... Coffea spp.
k71................... Castor bean............ Ricinus communis.
k72................... Ispaghula.............. Plantago psyllium/
Plantago ovata.
k73................... Silk waste............. NA.
k74................... Silk................... Bombyx mori.
k75................... Isocyanate TDI (Toluene NA.
diisocyanate).
k76................... Isocyanate MDI NA.
(Diphenylmethane
diisocyanate).
k77................... Isocyanate HDI NA.
(Hexamethylen
diisocyanate).
k78................... Ethylene oxide......... NA.
k79................... Phthalic anhydride..... NA.
k80................... Formaldehyde/Formalin.. NA.
k81................... Ficus.................. Ficus benjamina (Ficus
spp.).
k83................... Cotton seed............ Gossypium hirsutum.
k84................... Sunflower seed......... Helianthus annuus.
k85................... Chloramin T............ NA.
k86................... Trimellitic anhydride, NA.
TMA.
k87................... Asp o 21, alpha-amylase Aspergillus oryzae.
k89................... Orris root............. Iris florentina.
k99................... HSA (Human Serum Homo sapiens.
Albumin) (Hom s HSA).
k201.................. Car p 1, Papain........ Carica papaya.
k202.................. Ana c 2, Bromelain..... Ananas comosus.
k204.................. Maxatase............... Bacillus licheniformis.
k205.................. Alcalase............... Bacillus spp.
k206.................. Savinase, Protease 1 Bacillus spp.
(Bac l Subtilisin).
k208.................. Gal d 4, Lysozyme...... Gallus domesticus
(Gallus gallus
domesticus; Gallus
spp.).
k209.................. Hexahydrophtalic NA.
anhydrid.
k210.................. Maleic anhydride....... NA.
k211.................. Methyltetrahydrophtalic NA.
anhydrid.
k212.................. Abachi wood dust....... Triplochiton
scleroxylon.
k213.................. Pepsin (Sus s Pepsin).. Sus scrofa (Sus scrofa
domesticus; Sus spp.).
k213.................. TCPA................... NA.
k214.................. Bougainvillea.......... Bougainvillea spp.
k225.................. Horse radish peroxidase Armoracia rusticana.
(Arm r HRP).
k226.................. Ascorbate oxidase (Cuc Cucurbita pepo.
p ascorbate oxidase).
k301.................. Flour dust............. Triticum spp.
k501.................. Savinase customer Proprietary knowledge
specific. of customer.
k502.................. Lipolase customer Proprietary knowledge
specific. of customer.
k503.................. Termamyl customer Proprietary knowledge
specific. of customer.
k504.................. Clazinase customer Proprietary knowledge
specific. of customer.
------------------------------------------------------------------------

[[Page 32002]]

V. Reference

The following reference is on display in the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the Web site address, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. FDA Guidance, ``Procedures for Class II Device Exemptions From
Premarket Notification, Guidance for Industry and CDRH Staff,''
February 19, 1998, available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf.

Dated: July 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14453 Filed 7-10-17; 8:45 am]
BILLING CODE 4164-01-P

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