Authorization of Emergency Use of Certain In Vitro Diagnostic Devices; Availability, 20441-20480 [2010-8605]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 75, Number 74 (Monday, April 19, 2010)]
[Notices]
[Pages 20441-20480]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-8605]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0277]


Authorization of Emergency Use of Certain In Vitro Diagnostic 
Devices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of 10 Emergency Use Authorizations (EUAs) (the Authorizations) 
several of which were amended after initial issuance, for certain in 
vitro diagnostic devices. FDA also is announcing an amendment to the 
EUA for the Centers for Disease Control and Prevention (CDC) Swine 
Influenza Virus Real-time RT-PCR Detection Panel authorized on April 
27, 2009. FDA is issuing the Authorizations and amendments thereto 
under the Federal Food, Drug, and Cosmetic Act (the act). The 
Authorizations contain, among other things, conditions on the emergency 
use of the authorized in vitro diagnostics. The Authorizations follow

[[Page 20442]]

the determination by the Acting Secretary of the U.S. Department of 
Health and Human Services, Charles E. Johnson (the Acting Secretary), 
that a public health emergency exists involving Swine Influenza A (now 
known as 2009 H1N1 Influenza A, or 2009 H1N1 flu) that affects, or has 
the significant potential to affect, national security. On the basis of 
such determination, the Acting Secretary declared an emergency 
justifying the authorization of the emergency use of certain in vitro 
diagnostics, accompanied by emergency use information subject to the 
terms of any authorization issued under the Federal Food, Drug, and 
Cosmetic Act (the act). The Authorizations, which include explanations 
of the reasons for their issuance or reissuance, are reprinted in this 
document.

DATES:  See the SUPPLEMENTARY INFORMATION section of this document for 
effective dates of the Authorizations.

ADDRESSES: Submit written requests for single copies of the EUAs to the 
Office of Counterterrorism and Emerging Threats (HF-29), Food and Drug 
Administration, 5600 Fishers Lane, rm. 14C-26, Rockville, MD 20857. 
Send one self-addressed adhesive label to assist that office in 
processing your request or include a fax number to which the 
Authorization(s) may be sent. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the Authorizations.

FOR FURTHER INFORMATION CONTACT: RADM Boris Lushniak, Office of 
Counterterrorism and Emerging Threats (HF-29), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4067.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the act (21 U.S.C. 360bbb-3), as amended by the 
Project BioShield Act of 2004 (Public Law 108-276), allows FDA to 
strengthen the public health protections against biological, chemical, 
nuclear, and radiological agents. Among other things, section 564 of 
the act allows FDA to authorize the use of an unapproved medical 
product or an unapproved use of an approved medical product during a 
public health emergency that affects, or has a significant potential to 
affect, national security, and that involves biological, chemical, 
radiological, or nuclear agent or agents, or a specified disease or 
condition that may be attributable to such agent or agents. With this 
EUA authority, FDA can help assure that medical countermeasures may be 
used in an emergency to diagnose, treat, or prevent serious or life-
threatening diseases or conditions caused by such agents, when there 
are no adequate, approved, and available alternatives.
    Section 564(b)(1) of the act provides that, before an EUA may be 
issued, the Secretary must declare an emergency justifying the 
authorization based on one of the following grounds:
    (1) a determination by the Secretary of Homeland Security that 
there is a domestic emergency, or a significant potential for a 
domestic emergency, involving a heightened risk of attack with a 
specified biological, chemical, radiological, or nuclear agent or 
agents;
    (2) a determination by the Secretary of Defense that there is a 
military emergency, or a significant potential for a military 
emergency, involving a heightened risk to United States military forces 
of attack with a specified biological, chemical, radiological, or 
nuclear agent or agents; or
    (3) a determination by the Secretary of a public health emergency 
under section 319 of the Public Health Service Act (PHS Act) (42 U.S.C. 
247d) that affects, or has a significant potential to affect, national 
security, and that involves a specified biological, chemical, 
radiological, or nuclear agent or agents, or a specified disease or 
condition that may be attributable to such agent or agents.
    Once the Secretary has declared an emergency justifying an 
authorization under section 564 of the act, FDA may authorize the 
emergency use of a drug, device, or biological product if the agency 
concludes that the statutory criteria are satisfied. Under section 
564(h)(1) of the act, FDA is required to publish in the Federal 
Register a notice of each authorization, and each termination or 
revocation of an authorization, and an explanation of the reasons for 
the action. Section 564 of the act permits FDA to authorize the 
introduction into interstate commerce of a drug, device, or biological 
product intended for use in a declared emergency. Products appropriate 
for emergency use may include products and uses that are not approved, 
cleared, or licensed under sections 505, 510(k), and 515 of the act (21 
U.S.C. 355, 360(k), and 360e, respectively) or section 351 of the PHS 
Act (42 U.S.C. 262). FDA may issue an EUA only if, after consultation 
with the National Institutes of Health (NIH) and the CDC (to the extent 
feasible and appropriate given the circumstances of the emergency), 
FDA\1\ concludes:
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    \1\ The Secretary has delegated his authority to issue an EUA 
under section 564 of the act to the Commissioner of Food and Drugs.
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    (1) that an agent specified in a declaration of emergency can cause 
a serious or life-threatening disease or condition;
    (2) that, based on the totality of scientific evidence available to 
FDA, including data from adequate and well-controlled clinical trials, 
if available, it is reasonable to believe that:
     the product may be effective in diagnosing, treating, or 
preventing--
    [cir] such disease or condition; or
    [cir] a serious or life-threatening disease or condition caused by 
a product authorized under section 564 of the act, approved or cleared 
under the act, or licensed under Section 351 of the PHS Act, for 
diagnosing, treating, or preventing such a disease or condition caused 
by such an agent; and
     the known and potential benefits of the product, when used 
to diagnose, prevent, or treat such disease or condition, outweigh the 
known and potential risks of the product;
    [cir] that there is no adequate, approved, and available 
alternative to the product for diagnosing, preventing, or treating such 
disease or condition; and
    [cir] that such other criteria as the Secretary may by regulation 
prescribe are satisfied.
    No other criteria of issuance have been prescribed by regulation 
under Section 564(c)(4) of the act. Because the statute is self-
executing, FDA does not require regulations or guidance to implement 
the EUA authority. However, FDA published guidance in July 2007 
entitled ``Emergency Use Authorization of Medical Products'' to provide 
more information for stakeholders and the public about the EUA 
authority and the agency's process for the consideration of EUA 
requests.

II. EUA Request for Certain In Vitro Diagnostic Products

    On April 26, 2009, under section 564(b)(1)(C) of the act, the 
Acting Secretary determined that a public health emergency exists 
involving Swine Influenza A (now known as 2009 H1N1 Influenza A, or 
2009 H1N1 flu) that affects, or has the significant potential to 
affect, national security. The determination has been renewed. On April 
26, 2009, under section 564(b) of the act, and on the basis of such 
determination, the Acting Secretary declared an emergency justifying 
the authorization of certain in vitro diagnostics for detection of 
Swine Influenza A (2009 H1N1 flu), accompanied by emergency use 
information subject to the terms of any authorization issued under 
section

[[Page 20443]]

564(a) of the act. Notice of the determination and the declaration of 
the Acting Secretary was published in the Federal Register on August 4, 
2009 (74 FR 38628).
    (1) On July 23, 2009, in response to a request from Focus 
Diagnostics, Inc., FDA issued an EUA for the Focus Diagnostics 
Influenza A H1N1 (2009) Real-Time RT-PCR IVD device with certain 
written information, including fact sheets for healthcare providers and 
patients and adequate directions for use, which are authorized under 
the EUA. In response to requests from Focus Diagnostics, Inc., FDA 
amended the Authorization letter and reissued the Authorization letter 
in its entirety two times. On August 14, 2009, FDA amended the 
Authorization letter to authorize certain changes to the authorized 
labeling and permit future changes to the authorized labeling with 
written permission from FDA. On December 18, 2009, FDA amended the 
Authorization letter to authorize use of additional upper respiratory 
tract samples and lower respiratory tract specimens, and for other 
reasons. The Authorization letter, as amended and reissued on December 
18, 2009, which includes an explanation for its reissuance, is 
reprinted in this document. Because the December 2009 amendment 
incorporated both the July 2009 Authorization letter and the August 
2009 amendment to the Authorization letter in their entirety, the 
original July 2009 Authorization letter and the August 2009 amendment 
to the Authorization letter are not reprinted in this document.
    (2) On August 24, 2009, in response to a request from the 
Department of Defense (DOD), FDA issued an EUA for the CDC Swine 
Influenza Virus Real-time rRT-PCR Detection Panel on JBAIDS with 
certain written information, including fact sheets for healthcare 
providers and patients and adequate directions for use, which are 
authorized under the EUA. On December 18, 2009, in response to a 
request from DOD, FDA amended the Authorization letter to authorize use 
of additional upper respiratory tract samples and lower respiratory 
tract specimens, and for other reasons, and reissued the Authorization 
letter in its entirety. The Authorization letter, as amended and 
reissued on December 18, 2009, which includes an explanation for its 
reissuance, is reprinted in this document. The original August 2009 
Authorization letter is not reprinted in this document.
    (3) On October 9, 2009, in response to a request from Diatherix 
Laboratories, Inc., FDA issued an EUA for the Diatherix H1N1-09 
Influenza Test with certain written information, including fact sheets 
for healthcare providers and patients and adequate directions for use, 
which are authorized under the EUA. The Authorization letter, which 
includes an explanation for its issuance, is reprinted in this 
document.
    (4) On October 16, 2009, in response to a request from Focus 
Diagnostics, Inc., FDA issued an EUA for the Focus Diagnostics Simplexa 
Influenza A H1N1 (2009) with certain written information, including 
fact sheets for healthcare providers and patients and adequate 
directions for use, which are authorized under the EUA. On December 18, 
2009, in response to a request from Focus Diagnostics, Inc., FDA 
amended the Authorization letter to authorize use of additional upper 
respiratory tract samples and lower respiratory tract specimens, and 
for other reasons, and reissued the Authorization letter in its 
entirety. The Authorization letter, as amended and reissued on December 
18, 2009, which includes an explanation for its reissuance, is 
reprinted in this document. The original October 2009 Authorization 
letter is not reprinted in this document.
    (5) On October 27, 2009, in response to a request from Prodesse, 
Inc., FDA issued an EUA for the Prodesse ProFlu-ST Influenza A 
Subtyping Assay with certain written information, including fact sheets 
for healthcare providers and patients and adequate directions for use, 
which are authorized under the EUA. The Authorization letter, which 
includes an explanation for its issuance, is reprinted in this 
document.
    (6) On November 13, 2009, in response to a request from Epoch 
BioSciences, FDA issued an EUA for the ELITech Molecular Diagnostics 
2009-H1N1 Influenza A Virus Real Time RT-PCR test with certain written 
information, including fact sheets for healthcare providers and 
patients and adequate directions for use, which are authorized under 
the EUA. The Authorization letter, which includes an explanation for 
its issuance, is reprinted in this document.
    (7) On November 13, 2009, in response to a request from Roche 
Diagnostics GmbH, FDA issued an EUA for the Roche RealTime ready 
Influenza A/H1N1 Detection Set with certain written information, 
including fact sheets for healthcare providers and patients and 
adequate directions for use, which are authorized under the EUA. The 
Authorization letter, which includes an explanation for its issuance, 
is reprinted in this document.
    (8) On December 9, 2009, in response to a request from DxNA, LLC, 
FDA issued an EUA for the GeneSTAT 2009 A/H1N1 Influenza Test with 
certain written information, including fact sheets for healthcare 
providers and patients and adequate directions for use, which are 
authorized under the EUA. The Authorization letter, which includes an 
explanation for its issuance, is reprinted in this document.
    (9) On December 16, 2009, in response to a request from TessArae, 
LLC, FDA issued an EUA for the TessArray Resequencing Influenza A 
Microarray Detection Panel with certain written information, including 
fact sheets for healthcare providers and patients and adequate 
directions for use, which are authorized under the EUA. The 
Authorization letter, which includes an explanation for its issuance, 
is reprinted in this document.
    (10) On April 27, 2009, in response to a request from CDC, FDA 
issued an EUA for the CDC Swine Influenza Virus Real-time rRT-PCR 
Detection Panel. On May 2, 2009, in response to a request from CDC, FDA 
amended the Authorization letter to authorize the use of different 
sample types and reagents, and on August 4, 2009, notice of the initial 
Authorization and the amended Authorization was published in the 
Federal Register (74 FR 38636, August 4, 2009). On December 18, 2009, 
in response to a request from CDC, FDA amended the Authorization letter 
again to authorize the use of an additional upper respiratory tract 
specimen and use of lower respiratory tract specimens, to remove the 
word ``presumptive'' from the Intended Use, to allow the use of the CDC 
Swine Influenza Virus Real-time rRT-PCR Detection Panel as a stand 
alone test, and for other reasons. FDA reissued the Authorization 
letter in its entirety. The Authorization letter, as amended and 
reissued on December 18, 2009, which includes an explanation for its 
reissuance, is reprinted in this document.
    (11) On December 24, 2009, in response to a request from Cepheid, 
FDA issued an EUA for the Cepheid Xpert Flu A Panel with certain 
written information, including fact sheets for healthcare providers and 
patients and adequate directions for use, which are authorized under 
the EUA. The Authorization letter, which includes an explanation for 
its issuance, is reprinted in this document.

III. Effective Dates of the Authorizations

    The Authorizations are effective as follows:
    (1) The Authorization for Focus Diagnostics Influenza A H1N1 (2009)

[[Page 20444]]

Real-Time RT-PCR IVD device is effective as of July 23, 2009;
    (2) The Authorization for CDC Swine Influenza Virus Real-time rRT-
PCR Detection Panel on the Joint Biological Agent Identification and 
Diagnostic System Instrument (CDC Swine Influenza Virus Real-time rRT-
PCR Detection Panel JBAIDS) is effective as of August 24, 2009;
    (3) The Authorization for Diatherix H1N1-09 Influenza Test is 
effective as of October 9, 2009;
    (4) The Authorization for Focus Diagnostics Simplexa Influenza A 
H1N1 (2009) is effective as of October 16, 2009;
    (5) The Authorization for Prodesse ProFlu-ST Influenza A Subtyping 
Assay is effective as of October 27, 2009;
    (6) The Authorization for ELITech Molecular Diagnostics 2009-H1N1 
Influenza A virus Real-Time RT-PCR test by Associated Regional and 
University Pathologists Laboratories is effective as of November 13, 
2009;
    (7) The Authorization for Roche RealTime ready Influenza A/H1N1 
Detection Set is effective as of November 13, 2009;
    (8) The Authorization for GeneSTAT 2009 A/H1N1 Influenza Test is 
effective as of December 9, 2009;
    (9) The Authorization for TessArray Resequencing Influenza A 
Microarray Detection Panel is effective as of December 16, 2009;
    (10) The amendment to the EUA for the CDC Swine Influenza Virus 
Real-time rRT-PCR Detection Panel is effective as of December 18, 2009; 
and
    (11) The Authorization for Cepheid Xpert Flu A Panel is effective 
as of December 24, 2009.

IV. Electronic Access

    An electronic version of this document and the full text of the 
Authorizations are available on the Internet at https://www.regulations.gov.

V. The Authorizations

    Having concluded that the criteria for issuance of the 
Authorizations, one as amended, under section 564(c) of the act are 
met, FDA has authorized the emergency use of certain in vitro 
diagnostic devices.
    (1) The Authorization for Focus Diagnostics Influenza A H1N1 (2009) 
Real-Time RT-PCR IVD device issued on July 23, 2009, as amended and 
reissued in its entirety on December 18, 2009, follows and provides an 
explanation of the reasons for its issuance, as required by section 
564(h)(1) of the act:

 John G. R. Hurrell, Ph.D.
 Vice President and General Manager
 Focus Diagnostics, Inc.
 11331 Valley View Street
 Cypress, CA 90630
 
 
 Dear Dr. Hurrell:
 
 On July 23, 2009 FDA issued a letter authorizing the emergency use of the Focus Diagnostics Influenza A H1N1 (2009) Real-Time RT-PCR (Flu A H1N1 (2009) rRT-PCR ) for the diagnosis of 2009
 H1N1 influenza virus infection, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. Sec.  360bbb-3) by laboratories certified under the Clinical
 Laboratory Improvement Amendments of 1988, 42 U.S.C. Sec.  263a, to perform high complexity tests (CLIA High Complexity Laboratories). On November 20, 2009, Focus submitted a request for an
 amendment to the Emergency Use Authorization. In response to that request, the letter authorizing emergency use of the Flu A H1N1 (2009) rRT-PCR is being reissued in its entirety with the
 amendments incorporated.\1\
 
 On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. Sec.  360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is
 a public health emergency under 42 U.S.C. Sec.  247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical,
 radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents - in this case, 2009 H1N1 influenza virus.\2\ Pursuant to
 section 564(b) of the Act (21 U.S.C. Sec.  360bbb-3(b)), and on the basis of such determination, the Secretary of HHS then declared an emergency justifying the authorization of the emergency
 use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. Sec.  360bbb-3(a).
 
 Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. Sec.  360bbb-3(c)) are met, I am authorizing the emergency use of the Flu A
 H1N1 (2009) rRT-PCR for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection, subject to the terms of this authorization.
 
 I. Criteria for Issuance of Authorization
 
 I have concluded that the emergency use of the Flu A H1N1 (2009) rRT-PCR for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory
 infection meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:
 
    (1) The 2009 H1N1 influenza virus can cause influenza, a serious or life threatening disease or condition to humans infected by this virus;
 
    (2) Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the Flu A H1N1 (2009) rRT-PCR may be effective for the diagnosis of 2009 H1N1 influenza
     virus infection, and that the known and potential benefits of the Flu A H1N1 (2009) rRT-PCR, when used in the diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and
     potential risks of such product; and
 
    (3) There is no adequate, approved, and available alternative to the emergency use of the Flu A H1N1 (2009) rRT-PCR for the diagnosis of 2009 H1N1 influenza virus infection.\3\
 
 II. Scope of Authorization
 

[[Page 20445]]

 
 I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the authorized Flu A H1N1 (2009) rRT-PCR for the diagnosis of 2009
 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.
 
 The Authorized Flu A H1N1 (2009) rRT-PCR:
 
 The Focus Diagnostics Influenza A H1N1 (2009) Real Time RT-PCR test is a real-time RT-PCR assay that utilizes fluorogenic hydrolysis (Taqman[reg]) probes for use on the ABI 7500 Real-Time PCR
 instrument for the in vitro qualitative detection of 2009 H1N1 influenza viral RNA in upper respiratory tract specimens (such as nasopharyngeal swabs (NPS), nasal swabs (NS), throat swabs
 (TS), nasal aspirates (NA), nasal washes (NW), and dual nasopharyngeal/throat swabs (NPS/TS)), and lower respiratory tract specimens (such as broncheoalveolar lavage (BAL), bronchial aspirate
 (BA); bronchial wash (BW); endotracheal aspirate (EA); endotracheal wash (EW); tracheal aspirate (TA), and lung tissue) from patients with signs and symptoms of respiratory infection. The
 assay is composed of two principal steps: (1) extraction of RNA from patient specimens, (2) one-step reverse transcription and PCR amplification with human influenza A virus and the 2009 H1N1
 influenza virus-specific primers and real-time detection with influenza A and 2009 H1N1 influenza virus-specific probes.
 
 The Flu A H1N1 (2009) rRT-PCR includes the following primer and probe sets:
     FLU A detects a well-conserved region of the matrix gene from influenza A viruses in both human influenza A virus and 2009 H1N1 influenza virus.
     SWINE 1 and SWINE 2 specifically detect two separate regions of the 2009 H1N1 influenza virus strain's HA gene. The SWINE 1 and SWINE 2 reactions are not multiplexed and are
     performed in parallel in separate wells.
 
 The Flu A H1N1 (2009) rRT-PCR also includes control materials:
     Internal Positive Amplification Control (IPC): Exogenous IPC Reagent available separately from Applied Biosystems (Catalog No. 4308323). An internal positive control is included
     to confirm the absence of PCR inhibition.
     External Positive Control: Swine influenza virus stock (ATCC VR-897) diluted at 1:800.
     External Negative Control: Nuclease free water.
 
 The above described Flu A H1N1 (2009) rRT-PCR test, when labeled consistently with the labeling authorized by FDA, entitled Influenza A H1N1 (2009) Real-Time RT-PCR Package Insert, (see https://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm), as may be revised with written permission of FDA, is authorized to be distributed to and used by CLIA High Complexity
 Laboratories under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.
 
 The above described Flu A H1N1 (2009) rRT-PCR test is authorized to be accompanied by the following information pertaining to the emergency use, which is authorized to be made available to
 healthcare providers and patients:
 
     Fact Sheet For Healthcare Providers: Interpreting Focus Diagnostics Influenza A H1N1 (2009) Real-Time RT-PCR Test Results
     Fact Sheet For Patients: Understanding The Focus Diagnostics Influenza A H1N1 (2009) Real-Time RT-PCR Test Results
 
 As described in section IV below, Focus Diagnostics and CLIA High Complexity Laboratories are also authorized to make available additional information relating to the emergency use of the
 authorized Flu A H1N1 (2009) rRT-PCR that is consistent with, and does not exceed, the terms of this letter of authorization.
 
 I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized Flu A H1N1 (2009) rRT-PCR in the specified
 population, when used for diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such a product.
 
 I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized Flu A H1N1
 (2009) rRT-PCR may be effective in the diagnosis of 2009 H1N1 influenza virus infection pursuant to section 564(c)(2)(A) of the Act. The FDA has reviewed the scientific information available
 including the information supporting the conclusions described in Section I above, and concludes that the authorized Flu A H1N1 (2009) rRT-PCR when used to diagnose 2009 H1N1 influenza virus
 infection in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.
 
 The emergency use of the authorized Flu A H1N1 (2009) rRT-PCR under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of
 authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS's determination under section 564(b)(1)(C) described above and
 the Secretary of HHS's corresponding declaration under section 564(b)(1), the Flu A H1N1 (2009) rRT-PCR described above is authorized to diagnose 2009 H1N1 influenza virus infection in
 individuals with signs and symptoms of respiratory infection.
 
 This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.
 
 III. Waiver of Certain Requirements
 
 I am waiving the following requirements for the Flu A H1N1 (2009) rRT-PCR during the duration of this emergency use authorization:
 
     Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling,
     storage, and distribution of the Flu A H1N1 (2009) rRT-PCR.
 

[[Page 20446]]

 
     Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21
     CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information
     required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).
 
 IV. Conditions of Authorization
 
 Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
 
 Focus Diagnostics
 
  A. Focus Diagnostics will distribute the Flu A H1N1 (2009) rRT-PCR with the authorized labeling, as may be revised with written permission of FDA, only to CLIA High Complexity Laboratories.
 
  B. Focus Diagnostics will provide to the CLIA High Complexity Laboratories the authorized Flu A H1N1 (2009) rRT-PCR Fact Sheet for Healthcare Providers and the authorized Flu A H1N1 (2009)
   rRT-PCR Fact Sheet for Patients.
 
  C. Focus Diagnostics will make available on its website the authorized Flu A H1N1 (2009) rRT-PCR Fact Sheet for Healthcare Providers and the authorized Flu A H1N1 (2009) rRT-PCR Fact Sheet
   for Patients.
 
  D. Focus Diagnostics will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.
 
  E. All advertising and promotional descriptive printed matter relating to the use of the authorized Flu A H1N1 (2009) rRT-PCR shall be consistent with the Fact Sheets and authorized
   labeling, as well as the terms set forth in this EUA and other requirements set forth in the Act and FDA regulations.
 
  F. All advertising and promotional descriptive printed matter relating to the use of the Flu A H1N1 (2009) rRT-PCR shall clearly and conspicuously state that:
 
     This test has not been FDA cleared or approved;
 
     This test has been authorized by FDA under an Emergency Use Authorization;
 
     This test has been authorized only for the detection of 2009 H1N1 influenza virus and not for any other viruses or pathogens;
 
     This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. Sec.  360bbb-3(b)(1); and
 
     The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.
 
  G. No advertising or promotional descriptive printed matter relating to the use of the authorized Flu A H1N1 (2009) rRT-PCR may represent or suggest that this test is safe or effective for
   the diagnosis of 2009 H1N1 influenza virus.
 
  H. Focus Diagnostics will ensure CLIA High Complexity Laboratories using the authorized Flu A H1N1 (2009) rRT-PCR have a process in place for reporting test results to healthcare providers
   and federal, state and/or local public health authorities, as appropriate.
 
  I. Focus Diagnostics will track adverse events and report to FDA as required under 21 CFR part 803.
 
  J. Through a process of inventory control, Focus Diagnostics will maintain records of device usage.
 
  K. Focus Diagnostics will collect information on the performance of the assay, and report to FDA any suspected occurrence of false positive or false negative results of which Focus
   Diagnostics becomes aware.
 
 CLIA High Complexity Laboratories
 
  L. CLIA High Complexity Laboratories will include with reports of the results of the Flu A H1N1 (2009) rRT-PCR the authorized Fact Sheet for Healthcare Providers and the authorized Fact
   Sheet for Patients.
 
  M. CLIA High Complexity Laboratories will perform the assay on an Applied Biosystems 7500 Fast Dx Real-time PCR instrument or the RUO marketed Applied Biosystems 7500 Real-time PCR
   instrument.
 
  N. CLIA High Complexity Laboratories will have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as
   appropriate.
 
  O. CLIA High Complexity Laboratories will collect information on the performance of the assay, and report to Focus Diagnostics any suspected occurrence of false positive or false negative
   results of which CLIA High Complexity Laboratories become aware.
 
 Focus Diagnostics and CLIA High Complexity Laboratories
 
  P. Focus Diagnostics is authorized to make available additional information relating to the emergency use of the authorized Flu A H1N1 (2009) rRT-PCR that is consistent with, and does not
   exceed, the terms of this letter of authorization.
 

[[Page 20447]]

 
  Q. Only Focus Diagnostics may request changes to the authorized Fact Sheet for Healthcare Providers or the authorized Flu A H1N1 (2009) rRT-PCR Fact Sheet for Patients. Such requests will be
   made by contacting FDA concerning FDA review and approval.
 
  R. Focus Diagnostics will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon request.
 
 The emergency use of the authorized Flu A H1N1 (2009) rRT-PCR as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.
 
 V. Duration of Authorization
 
 This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.
 
                   Margaret A. Hamburg, M.D.
                   Commissioner of Food and Drugs
 
 
 \1\ The amendments to the July 23, 2009 letter authorize use of additional upper respiratory tract samples, such as nasal swabs (NS), throat swabs (TS), nasal aspirates (NA), nasal washes
  (NW), and dual nasopharyngeal / throat swabs (NPS/TS), and lower respiratory tract specimens, such as broncheoalveolar lavage (BAL), bronchial aspirate (BA), bronchial wash (BW),
  endotracheal aspirate (EA), endotracheal wash (EW), tracheal aspirate (TA), and lung tissue. There are also corrections to the waiver section and minor wording changes made to be consistent
  with more recently issued Emergency Use Authorizations for in vitro diagnostic devices.
\2\ Memorandum, Determination Pursuant to Sec.   564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009).
\3\ No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.

    (2) The Authorization for the CDC Swine Influenza Virus Real-time 
rRT-PCR Detection Panel on JBAIDS issued on August 24, 2009, as amended 
and reissued in its entirety on December 18, 2009, follows and provides 
an explanation of the reasons for its issuance, as required by section 
564(h)(1) of the act:

 Robert E. Miller, Ph.D., RAC
 Director
 United States Army Medical Material Development Activity
 1430 Veterans Drive
 Ft. Detrick, Maryland 21702-9232
 
 Dear Dr. Miller:
 
 On August 24, 2009, FDA issued a letter authorizing the emergency use of the CDC swH1N1 (swine) Influenza Virus Real-time RT-PCR Detection Panel on the Joint Biological Agent Identification
 and Diagnostic System (JBAIDS)\1\ Instrument (rRT-PCR Swine Flu Panel on JBAIDS) for the diagnosis of 2009 H1N1 influenza virus infection, pursuant to section 564 of the Federal Food, Drug,
 and Cosmetic Act (the Act) (21 U.S.C. Sec.   360bbb-3) by qualified Department of Defense (DoD) laboratories that are equipped with the JBAIDS instruments. On November 16, 2009, the Office of
 the Surgeon General, Department of the Army submitted a request for an amendment to the Emergency Use Authorization. In response to that request, the letter authorizing emergency use of the
 rRT-PCR Swine Flu Panel on JBAIDS is being reissued in its entirety with the amendments, as requested by the Office of the Surgeon General, Department of the Army, incorporated.\2\
 
 On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. Sec.   360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there
 is a public health emergency under 42 U.S.C. Sec.   247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical,
 radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents - in this case, 2009 H1N1 influenza virus.\3\ Pursuant to
 section 564(b) of the Act (21 U.S.C. Sec.  360bbb-3(b)), and on the basis of such determination, the Secretary of HHS then declared an emergency justifying the authorization of the emergency
 use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. Sec.  360bbb-3(a).
 
 Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. Sec.  360bbb-3(c)) are met, I am authorizing the emergency use of the rRT-PCR
 Swine Flu Panel on JBAIDS (as described in the scope section of this letter (Section II)) for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of
 respiratory infection, subject to the terms of this authorization.
 
 I. Criteria for Issuance of Authorization
 
 I have concluded that the emergency use of the rRT-PCR Swine Flu Panel on JBAIDS for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory
 infection meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:
 
    (1) The 2009 H1N1 influenza virus can cause influenza, a serious or life threatening disease or condition to humans infected by this virus;
 
    (2) Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the rRT-PCR Swine Flu Panel on JBAIDS may be effective for the diagnosis of 2009 H1N1
     influenza virus infection, and that the known and potential benefits of the rRT-PCR Swine Flu Panel on JBAIDS, when used in the diagnosis of 2009 H1N1 influenza virus infection, outweigh
     the known and potential risks of such products; and

[[Page 20448]]

 
 
    (3) There is no adequate, approved, and available alternative to the emergency use of the rRT-PCR Swine Flu Panel on JBAIDS for the diagnosis of 2009 H1N1 influenza virus infection.\4\
 
 II. Scope of Authorization
 
 I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the authorized rRT-PCR Swine Flu Panel on JBAIDS for the diagnosis of
 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.
 
 The authorized rRT-PCR Swine Flu Panel on JBAIDS:
 
 rRT-PCR Swine Flu Panel on JBAIDS is a panel of oligonucleotide primers and dual-labeled hydrolysis (Taqman[reg]) probes for use in the real-time RT-PCR assay on the Joint Biological Agent
 Identification and Diagnostic System (JBAIDS) instrument for the in vitro qualitative detection of 2009 H1N1 influenza viral RNA in upper respiratory tract specimens, such as nasopharyngeal
 swabs (NPS), nasal swabs (NS), throat swabs (TS), nasal aspirates (NA), nasal washes (NW), and dual nasopharyngeal / throat swabs (NPS/TS), and lower respiratory tract specimens (LRTS), such
 as broncheoalveolar lavage (BAL), bronchial aspirate (BA), bronchial wash (BW), endotracheal aspirate (EA), endotracheal wash (EW), tracheal aspirate (TA), and lung tissue, from patients with
 signs and symptoms of respiratory infection and in viral culture.
 
 The rRT-PCR Swine Flu Panel on JBAIDS includes the following primer and probe sets:
     InfA detects universal influenza A strains
     swInfA specifically detects swine influenza A strains (NP gene)
     swH1 is specific for swine influenza A, subtype H1 (HA gene)
 
 The rRT-PCR Swine Flu Panel on JBAIDS also includes control materials:
     RNase P (RP) detects human RNase P and is used as a positive control with human clinical specimens to indicate that adequate isolation of nucleic acid resulted from the extraction
     of the clinical specimen.
     Swine Influenza Panel Real-Time RT-PCR Positive Control (SIPC) is a positive control designed to react with all the primer and probe sets including RNase P.
 
 The rRT-PCR Swine Flu Panel on JBAIDS requires the following hardware and software:
     JBAIDS Instrument is a real-time polymerase chain reaction (PCR) instrument developed as part of a biothreat detection system for the Department of Defense (DoD). It comes with a
     ruggedized laptop computer loaded with specific, user-friendly system software.
     JBAIDS Influenza Specific Macro is a compact disc (CD) provided by the JBAIDS Training Facility that contains the Influenza specific macro with Operating Instructions.
 
 The rRT-PCR Swine Flu Panel on JBAIDS requires the use of the following nucleic acid extraction kit:
     Qiagen QIAamp Viral RNA Mini kit and protocol
 
 The above described rRT-PCR Swine Flu Panel on JBAIDS, when labeled consistently with the labeling authorized by FDA, entitled CDC swH1N1 (swine) Influenza Virus Real-time RT-PCR Detection
 Panel (rRT-PCR Swine Flu Panel) on JBAIDS (see https://www.fda.gov/medicaldevices/Safety/emergencysituations/ucm161496.htm), as may be revised with written permission of FDA, is authorized to
 be distributed to and used by qualified Department of Defense (DoD) laboratories\5\ that are equipped with the JBAIDS instruments under this EUA, despite the fact that it does not meet
 certain requirements otherwise required by federal law.
 
 The above described rRT-PCR Swine Flu Panel on JBAIDS is authorized to be accompanied by the following information pertaining to the emergency use, which is authorized to be made available to
 healthcare providers and patients:
 
     Fact Sheet For Healthcare Providers: Interpreting Test Results Obtained with the CDC swH1N1 (swine) Influenza Virus Real-time RT-PCR Detection Panel on the Joint Biological Agent
     Identification and Diagnostic System (JBAIDS) Instrument
     Fact Sheet For Patients: Understanding Test Results Obtained with the CDC swH1N1 (swine) Influenza Virus Real-time RT-PCR Detection Panel on the Joint Biological Agent
     Identification and Diagnostic System (JBAIDS) Instrument
 
 As described in section IV below, DoD and JBAIDS are also authorized to make available additional information relating to the emergency use of the authorized rRT-PCR Swine Flu Panel on JBAIDS
 that is consistent with, and does not exceed, the terms of this letter of authorization.
 
 I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized rRT-PCR Swine Flu Panel on JBAIDS in the
 specified population, when used for diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such a product.
 
 I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized rRT-PCR Swine
 Flu Panel on JBAIDS may be effective in the diagnosis of 2009 H1N1 influenza virus infection pursuant to section 564(c)(2)(A) of the Act. FDA has reviewed the scientific information available
 including the information supporting the conclusions described in Section I above, and concludes that the authorized rRT-PCR Swine Flu Panel on JBAIDS, when used to diagnose 2009 H1N1
 influenza virus infection in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.
 
 The emergency use of the authorized rRT-PCR Swine Flu Panel on JBAIDS under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the
 conditions of authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS's determination under section 564(b)(1)(C)
 described above and the Secretary of HHS's corresponding declaration under section 564(b)(1), the rRT-PCR Swine Flu Panel on JBAIDS described above is authorized to diagnose 2009 H1N1
 influenza virus infection in individuals with signs and symptoms of respiratory infection.

[[Page 20449]]

 
 
 This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.
 
 III. Waiver of Certain Requirements
 
 I am waiving the following requirements for the rRT-PCR Swine Flu Panel on JBAIDS during the duration of this emergency use authorization:
 
     Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling,
     storage, and distribution of the rRT-PCR Swine Flu Panel on JBAIDS
 
     Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21
     CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information
     required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).
 
 IV. Conditions of Authorization
 
 Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
 
 DoD/ Joint Project Management Office (JPMO), Chemical Biological Medical Systems (CBMS)
 
  A. DoD/JPMO,CBMS will distribute the rRT-PCR Swine Flu Panel on JBAIDS with the authorized labeling, as may be revised with written permission of FDA, only to qualified DoD laboratories that
   are equipped with the JBAIDS instruments.
 
  B. DoD/JPMO,CBMS will provide to the qualified DoD laboratories the authorized rRT-PCR Swine Flu Panel on JBAIDS Fact Sheets for Healthcare Providers, and the authorized rRT-PCR Swine Flu
   Panel on JBAIDS Fact Sheets for Patients.
 
  C. DoD/JPMO,CBMS will make available on its website the authorized rRT-PCR Swine Flu Panel on JBAIDS Fact Sheets for Healthcare Providers, and the authorized rRT-PCR Swine Flu Panel on
   JBAIDS Fact Sheets for Patients.
 
  D. DoD/JPMO,CBMS will ensure that the state and/or local public health authority(ies) are informed of this EUA, including the terms and conditions herein.
 
  E. DoD/JPMO,CBMS will ensure that qualified DoD laboratories using the authorized rRT-PCR Swine Flu Panel on BAIDS have a process in place for reporting test results to health care providers
   and federal, state and/or local public health authorities, as appropriate.
 
  F. DoD/JPMO,CBMS will track adverse events and report to FDA as required under 21 CFT part 803..
 
  G. Through a process of inventory control, DoD/JPMO,CBMS will maintain records of device usage.
 
  H. DoD/JPMO,CBMS will collect information on the performance of the assay, to include the incidence of false positive and negative results.
 
 Qualified DoD Laboratories
 
  I. Qualified DoD laboratories will include with reports of the results of the rRT-PCR Swine Flu Panel on JBAIDS, the authorized Fact Sheets for Healthcare Providers and the authorized Fact
   Sheet for Patients.
 
  J. Qualified DoD laboratories will perform the assay on a JBAIDS instrument.
 
  K. Qualified DoD laboratories will have a process in place for reporting test results to health care providers and federal, state and/or local public health authorities, as appropriate.
 
  L. Qualified DoD laboratories will collect information on the performance of the assay, and report to DoD/JPMO,CBMS any suspected occurrence of false positive or false negative results of
   which Qualified DoD laboratories become aware.
 
 DoD/ Joint Project Management Office (JPMO), Chemical Biological Medical Systems (CBMS) and Qualified DoD Laboratories
 
  M. DoD/JPMO,CBMS is authorized to make available additional information relating to the emergency use of the authorized rRT-PCR Swine Flu Panel on JBAIDS that is consistent with, and does
   not exceed, the terms of this letter of authorization.
 
  N. Only DoD/JPMO,CBMS may request changes to the authorized rRT-PCR Swine Flu Panel on JBAIDS Fact Sheet for Healthcare Providers or the authorized rRT-PCR Swine Flu Panel on JBAIDS Fact
   Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and approval.
 
  O. DoD/JPMO,CBMS and the qualified DoD laboratories will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for
   inspection upon request.
 
 The emergency use of the authorized rRT-PCR Swine Flu Panel on JBAIDS as described in this letter of authorization must comply with the conditions above and all other terms of this
 authorization.
 

[[Page 20450]]

 
 V. Duration of Authorization
 
 This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.
 
                   Margaret A. Hamburg, M.D.
                   Commissioner of Food and Drugs
 
 
 \1\ For ease of reference, this letter will use the term the ``rRT-PCR Swine Flu Panel on JBAIDS.''
\2\ The amendments to the August 24, 2009 letter authorize use of additional upper respiratory tract samples, such as nasal swabs (NS), throat swabs (TS), nasal aspirates (NA), nasal washes
  (NW), and dual nasopharyngeal / throat swabs (NPS/TS), and lower respiratory tract specimens, such as broncheoalveolar lavage (BAL), bronchial aspirate (BA), bronchial wash (BW),
  endotracheal aspirate (EA), endotracheal wash (EW), tracheal aspirate (TA), and lung tissue. There are also corrections to the waiver section, an additional condition for DoD Laboratories,
  and minor wording changes made to be consistent with more recently issued Emergency Use Authorizations for in vitro diagnostic devices.
\3\ Memorandum, Determination Pursuant to Sec.   564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009).
\4\ No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
\5\ All users, analysts, and any person reporting diagnostic results from use of this device should be trained to perform and interpret the results from this procedure by JBAIDS instructors or
  designees prior to use. Use of this device is limited to qualified Department of Defense (DoD) laboratories equipped with the JBAIDS instruments. See ``Conditions of Authorization'' below.

    (3) The Authorization for Diatherix H1N1-09 Influenza Test issued 
on October 9, 2009, follows and provides an explanation of the reasons 
for its issuance, as required by section 564(h)(1) of the act:

 Dennis L. Grimaud
 Chairman and Chief Executive Officer
 DIATHERIX Laboratories, Inc.
 601 Genome Way, Suite 4208
 Huntsville, AL 35806
 
 Dear Mr.Grimaud:
 
 This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of the DIATHERIX H1N1-09 Influenza Test for
 the diagnosis of 2009 H1N1 influenza virus infection, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. Sec.  360bbb-3), by DIATHERIX Laboratories,
 Inc., a CLIA High Complexity Laboratory certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. Sec.  263a, to perform high complexity tests.
 
 On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. Sec.  360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is
 a public health emergency under 42 U.S.C. Sec.  247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical,
 radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents - in this case, 2009 H1N1 influenza virus.\1\ Pursuant to
 section 564(b) of the Act (21 U.S.C. Sec.  360bbb-3(b)), and on the basis of such determination, the Secretary of HHS then declared an emergency justifying the authorization of the emergency
 use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. Sec.  360bbb-3(a).
 
 Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. Sec.  360bbb-3(c)) are met, I am authorizing the emergency use of the
 DIATHERIX H1N1-09 Influenza Test (as described in the scope section of this letter (Section II)) for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and
 symptoms of respiratory infection, subject to the terms of this authorization.
 
 I. Criteria for Issuance of Authorization
 
 I have concluded that the emergency use of the DIATHERIX H1N1-09 Influenza Test for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory
 infection meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:
 
    1. The recently isolated 2009 H1N1 influenza virus can cause influenza, a serious or life threatening disease or condition to humans infected by this virus.
 
    2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the DIATHERIX H1N1-09 Influenza Test may be effective for the diagnosis of 2009 H1N1
     influenza virus infection, and that the known and potential benefits of the DIATHERIX H1N1-09 Influenza Test, when used in the diagnosis of 2009 H1N1 influenza virus infection, outweigh
     the known and potential risks of such product; and
 
    3. There is no adequate, approved, and available alternative to the emergency use of the DIATHERIX H1N1-09 Influenza Test for the diagnosis of 2009 H1N1 influenza virus infection.\2\
 
 Therefore, I have concluded that the emergency use of the DIATHERIX H1N1-09 Influenza Test for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of
 respiratory infection meets the above criteria for issuance of an authorization.
 
 II. Scope of Authorization
 

[[Page 20451]]

 
 I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the authorized DIATHERIX H1N1-09 Influenza Test for the diagnosis of
 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.
 
 The Authorized DIATHERIX H1N1-09 Influenza Test:
 
 The DIATHERIX H1N1-09 Influenza Test is a multiplexed molecular diagnostic assay that performs target enriched multiplex PCR nucleic acid amplification on the ABI 9700 thermocycler followed
 by probe hybridization and subsequent detection on the Qiagen Luminex LiquiChip 100 platform for the in vitro qualitative detection of 2009 H1N1 influenza viral RNA in nasopharyngeal swabs,
 nasal swabs, throat swabs, nasal aspirates, and nasopharyngeal aspirates specimens from patients with signs and symptoms of respiratory infection.
 
 The DIATHERIX H1N1-09 Influenza Test includes the following primer and probe sets:
 
     H1 (H109C): a total of 4 primers designed for nested PCR to detect the presence of the hemagglutinin gene specifically found in the 2009 H1N1 influenza A virus.
 
     N1 (N109B): a total of 4 primers designed for nested PCR to detect the presence of the neuraminidase gene specifically found in the 2009 H1N1 influenza A virus.
 
     Probes: each amplicon is hybridized to complementary capture probes (H109C De and N109B De, respectively), which are covalently coupled to color coded beads detectable by the
     Luminex technology.
 
 The DIATHERIX H1N1-09 Influenza Test also includes the following control materials:
 
     ABM, extraction positive control: Acinetobacter baumannii, ATCC strain 19606, will be used as a culture stock diluted and subjected to extraction as an additional sample during
     each batch of patient specimen extractions to demonstrate the effectiveness of the extraction method (rule out false negatives due to extraction failure and false positives due to
     carryover contamination).
 
     PCR Blank, negative control: A water blank will be run as an additional PCR sample during each batch of patient specimen testing to demonstrate that no carryover contamination has
     occurred during the PCR process (rule out false positives).
 
     PCR positive control: Nucleic acid from Haemophilus influenzae, ATCC strain 10211, will be run as a separate PCR sample with each batch run of patient specimens. The PCR positive
     control demonstrates the effectiveness of the PCR reaction to amplify targets in the assay (rule out PCR false negatives).
 
     PCR positive internal control: DNA from Acinetobacter baumannii ATCC strain 19606 will be added to each PCR to act as an internal amplification control. For each sample, if either
     the ABM target or any other target is positive, the PCR passes. If both ABM and all other targets fail to produce a positive signal, the PCR has failed and must be repeated.
 
 The DIATHERIX H1N1-09 Influenza Test requires the following hardware with corresponding software:
 
     Thermo Fisher Kingfisher 96, software version 2.6.2: nucleic acid extraction instrument.
 
     ABI 9700 Thermocycler, software version 3.09: PCR amplification instrument.
 
     Qiagen Luminex LiquiChip 100, software version 2.3.182: bead detection instrumentation.
 
 The DIATHERIX H1N1-09 Influenza Test requires the use of the following additional reagent kits:
 
     Starplex Collection Kit (tube, swab, medium, biohazard bag and shipping box) (Catalog number: SP132-FL75).
 
     Scigenix MagnetX Extraction Kit (Catalog number: R2-2400-DTX-I0).
 
     Qiagen OneStep RT-PCR Kit (Catalog number: 210212).
 
     BioRad Luminex beads (Catalog number: 171506xx).
 
 The above described DIATHERIX H1N1-09 Influenza Test, when labeled consistently with the labeling authorized by FDA, entitled Diatherix Laboratories H1N1-09 Influenza Test Package Insert, as
 may be revised with written permission of FDA, is authorized to be used by DIATHERIX Laboratories, Inc.,\3\ under this EUA, despite the fact that it does not meet certain requirements
 otherwise required by federal law.
 
 The above described DIATHERIX H1N1-09 Influenza Test is authorized to be accompanied by the following information pertaining to the emergency use, which are authorized to be made available to
 healthcare providers and patients:
 
     Fact Sheet for Healthcare Providers: Interpretation of the DIATHERIX H1N1-09 Influenza Virus Test Results
 
     Fact Sheet for Patients: Understanding the DIATHERIX H1N1-09 Influenza Virus Test Results
 
 As described in section IV below, DIATHERIX Laboratories, Inc., is also authorized to make available additional information relating to the emergency use of the authorized DIATHERIX H1N1-09
 Influenza Test that is consistent with, and does not exceed, the terms of this letter of authorization.
 

[[Page 20452]]

 
 I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized DIATHERIX H1N1-09 Influenza Test in the
 specified population, when used for diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such a product.
 
 I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized DIATHERIX H1N1-
 09 Influenza Test may be effective in the diagnosis of 2009 H1N1 influenza virus infection pursuant to section 564(c)(2)(A) of the Act. The FDA has reviewed the scientific information
 available including the information supporting the conclusions described in Section I above, and concludes that the authorized DIATHERIX H1N1-09 Influenza Test, when used to diagnose 2009
 H1N1 influenza virus infection in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.
 
 The emergency use of the authorized DIATHERIX H1N1-09 Influenza Test under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the
 conditions of authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS' determination under section 564(b)(1)(C) described
 above and the Secretary of HHS' corresponding declaration under section 564(b)(1), the DIATHERIX H1N1-09 Influenza Test described above is authorized to diagnose 2009 H1N1 influenza virus
 infection in individuals with signs and symptoms of respiratory infection.
 
 This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.
 
 III. Waiver of Certain Requirements
 
 I am waiving the following requirements for the DIATHERIX H1N1-09 Influenza Test during the duration of this emergency use authorization:
 
     Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, and
     storage of the DIATHERIX H1N1-09 Influenza Test.
 
     Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21
     CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information
     required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).
 
 IV. Conditions of Authorization
 
 Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
 
 DIATHERIX Laboratories, Inc.
 
  A. DIATHERIX Laboratories, Inc., will not sell or distribute the DIATHERIX H1N1-09 Influenza Test to other laboratories.
 
  B. DIATHERIX Laboratories, Inc., will include with reports of the results of the DIATHERIX H1N1-09 Influenza Test the authorized DIATHERIX H1N1-09 Influenza Test Fact Sheets for Healthcare
   Providers and the authorized DIATHERIX H1N1-09 Influenza Test Fact Sheets for Patients.
 
  C. DIATHERIX Laboratories, Inc., will make available on its Web site the authorized DIATHERIX H1N1-09 Influenza Test Fact Sheets for Healthcare Providers and the authorized DIATHERIX H1N1-09
   Influenza Test Fact Sheets for Patients.
 
  D. DIATHERIX Laboratories, Inc., will clearly and conspicuously state on reports of the results of the DIATHERIX H1N1-09 Influenza Test that this test is only authorized for the diagnosis of
   2009 H1N1 influenza virus and not for seasonal influenza A, B, or any other pathogen.
 
  E. DIATHERIX Laboratories, Inc., will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.
 
  F. All advertising and promotional descriptive printed matter relating to the use of the DIATHERIX H1N1-09 Influenza Test shall be consistent with the Fact Sheets and authorized labeling, as
   well as the terms set forth in this EUA and other requirements set forth in the Act and FDA regulations.
 
  G. All advertising and promotional descriptive printed matter relating to the use of the DIATHERIX H1N1-09 Influenza Test shall clearly and conspicuously state that:
 
     This test has not been FDA cleared or approved;
 
     This test has been authorized by FDA under an Emergency Use Authorization;
 
     This test has been authorized only for the detection of 2009 H1N1 influenza virus and not for any other viruses or pathogens;
 
     This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. Sec.  360bbb-3(b)(1); and
 
     The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.
 

[[Page 20453]]

 
  H. No advertising or promotional descriptive printed matter relating to the use of the DIATHERIX H1N1-09 Influenza Test assay may represent or suggest that this test is safe or effective for
   the diagnosis of 2009 H1N1 influenza virus.
 
  I. DIATHERIX Laboratories, Inc., will have a process in place