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U.S. Department of Health and Human Services

Medical Devices

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Letter of Authorization: ViraCor 2009 H1N1 Influenza A Real-time RT-PCR

The information previously contained on these webpages were authorized under the 2009 H1N1 Influenza Emergency Use Authorizations (EUAs). As of June 23, 2010, the EUAs have been terminated and this information is no longer current.

January 21, 2010

Renée Forsberg, ASQ CQA
Director, Regulatory Affairs and Quality Assurance
ViraCor Laboratories
1001 NW Technology Drive
Lee’s Summit, MO 64086

Dear Ms. Forsberg:

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 ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test by ViraCor Laboratories for the diagnosis of 2009 H1N1 influenza virus infection in patients with signs and symptoms of respiratory infection, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3). ViraCor Laboratories is certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. §263a, to perform high complexity tests (a CLIA High Complexity Laboratory).

On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. §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. §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. §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. §360bbb-3(a).

Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. §360bbb-3(c)) are met, I am authorizing the emergency use of the ViraCor 2009 H1N1 Influenza A Real-time RT-PCR 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 ViraCor 2009 H1N1 Influenza A Real-time RT-PCR 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 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 ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test may be effective for the diagnosis of 2009 H1N1 influenza virus infection, and that the known and potential benefits of the ViraCor 2009 H1N1 Influenza A Real-time RT-PCR 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 ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test for the diagnosis of 2009 H1N1 influenza virus infection.2

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 ViraCor Laboratories' use of the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.

The Authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test:

The ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test is a real-time reverse transcriptase PCR (rRT-PCR) 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 testing procedure consists of nucleic acid extraction on the NucliSENS ® easyMAG ® system (bioMérieux, Inc.) followed by rRT-PCR on the Applied Biosystems 7500 Real-Time PCR System.

The ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test includes the following primer and probe sets:

  • INFA: detects a conserved region of the matrix (M) gene that is present in both seasonal and 2009 H1N1 influenza A viruses.
  • 2009 H1N1: detects a region of the hemagglutinin (H) gene found in the 2009 H1N1 influenza virus. This primer/probe set may react with other swine origin influenza A strains.
  • IC (Internal Control): detects an RNA sequence in whole bacteriophage MS2 that is noncompetitive with the INFA and 2009 H1N1 2009 targets.

The ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test also includes the following control materials:

  • Bacteriophage MS2 Internal Control (IC) is added to every patient sample and is carried through all steps of the procedure from nucleic acid isolation and purification through amplification to ensure that effective nucleic acid extraction is achieved and to monitor for inhibition of rRT-PCR.
  • Negative Control consists of a known negative sample and is taken through both nucleic acid extraction and rRT-PCR processes to demonstrate that all extraction and amplification reagents are free of target RNA and amplicons and to ensure that detection of target genes is not due to false positive results.
  • Positive Controls consist of separate in vitro transcribed RNAs containing targets recognized by the INFA and 2009 H1N1 detection systems and are included in each rRT-PCR run to demonstrate that these detection systems are operating at the required level of sensitivity.

The ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test requires the following hardware with corresponding software:

  • Applied Biosystems 7500 Real-Time PCR System with ABI Software: SDS software version 1.4.
  • bioMérieux NucliSENS ® easyMAG ® extraction system with software version 2.0

The ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test requires the use of the following additional reagents/materials:

  • SuperScript™ III Platinum ® One-Step qRT-PCR kit (Invitrogen Cat. No. 11732-088)
  • Extraction Reagents for NucliSENS ® easyMAG ® system (bioMérieux Cat. Nos. 280130, 280131, 280132, 280133, 280134).

The above described ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test , when labeled consistently with the labeling authorized by FDA, entitled ViraCor 2009 H1N1 Influenza A Real-time RT-PCR Package Insert (available at http://www.fda.gov/MedicalDevices/ Safety/EmergencySituations/ucm161496.htm), as may be revised with written permission of FDA, is authorized to be used by ViraCor Laboratories,3 under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.

The above described ViraCor 2009 H1N1 Influenza A Real-time RT-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 ViraCor 2009 H1N1 Influenza A Real-time RT-PCR Test Results
  • Fact Sheet for Patients: Understanding ViraCor 2009 H1N1 Influenza A Real-time RT-PCR Test Results

As described in section IV below, ViraCor Laboratories is also authorized to make available additional information relating to the emergency use of the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test 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 ViraCor 2009 H1N1 Influenza A Real-time RT-PCR 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 ViraCor 2009 H1N1 Influenza A Real-time RT-PCR 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 ViraCor 2009 H1N1 Influenza A Real-time RT-PCR 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 ViraCor 2009 H1N1 Influenza A Real-time RT-PCR 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's determination under section 564(b)(1)(C) described above and the Secretary of HHS's corresponding declaration under section 564(b)(1), the ViraCor 2009 H1N1 Influenza A Real-time RT-PCR 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 ViraCor 2009 H1N1 Influenza A Real-time RT-PCR 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, storage, and distribution of the ViraCor 2009 H1N1 Influenza A Real-time RT-PCR 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:

ViraCor Laboratories

  1. ViraCor Laboratories, Inc., will not sell or distribute the ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test to other laboratories.
  2. ViraCor Laboratories will include with reports of the results of the ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test Fact Sheet for Healthcare Providers and the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test Fact Sheet for Patients.
  3. ViraCor Laboratories will make available on its Web site the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test Fact Sheet for Healthcare Providers and the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test Fact Sheet for Patients.
  4. ViraCor Laboratories will clearly and conspicuously state on reports of the results of the ViraCor 2009 H1N1 Influenza A Real-time RT-PCR 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 virus or pathogen.
  5. ViraCor Laboratories will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.
  6. All advertising and promotional descriptive printed matter relating to the use of the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR 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.
  7. All advertising and promotional descriptive printed matter relating to the use of the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1); and
    • The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.
  8. No advertising or promotional descriptive printed matter relating to the use of the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test may represent or suggest that this test is safe or effective for the diagnosis of 2009 H1N1 influenza virus.
  9. ViraCor 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.
  10. ViraCor Laboratories will track adverse events and report to FDA as required under 21 CFR part 803.
  11. Through a process of inventory control, ViraCor Laboratories will maintain records of device usage.
  12. ViraCor Laboratories 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 ViraCor Laboratories becomes aware.
  13. ViraCor Laboratories is authorized to make available additional information relating to the emergency use of the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test that is consistent with, and does not exceed, the terms of this letter of authorization.
  14. Only ViraCor Laboratories may request changes to the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test Fact Sheet for Healthcare Providers or the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test Fact Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and approval.
  15. ViraCor Laboratories will perform the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test on the bioMérieux NucliSENS ® easyMAG ® extraction system with software version 2.0 and Applied Biosystems 7500 Real-Time PCR System with SDS software version 1.4.
  16. ViraCor 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 ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test 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 Memorandum, Determination Pursuant to § 564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009).

2 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.

3 This EUA does not authorize the ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test to be sold or distributed to or used by other laboratories.