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U.S. Department of Health and Human Services

Medical Devices

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Letter of Authorization: IQuum Liat™ Influenza A/2009 H1N1 Assay

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 As of June 23, 2010, the EUAs have been terminated and this information is no longer current.

Shuqi Chen, PhD
CEO
IQuum, Inc.
700 Nickerson Road
Marlborough, MA 01752

Dear Dr. Chen:

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 Liat™ Influenza A/2009 H1N1 Assay for the diagnosis of 2009 H1N1 influenza virus infection in patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3) by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate complexity tests and by laboratories certified under CLIA to perform high complexity tests.

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 Liat Influenza A/2009 H1N1 Assay (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 in conjunction with clinical and epidemiological risk factors, subject to the terms of this authorization.

I. Criteria for Issuance of Authorization

I have concluded that the emergency use of the Liat Influenza A/2009 H1N1 Assay for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors 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 Liat Influenza A/2009 H1N1 Assay may be effective for the diagnosis of 2009 H1N1 influenza virus infection, and that the known and potential benefits of the Liat Influenza A/2009 H1N1 Assay , 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 Liat Influenza A/2009 H1N1 Assay 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 the use of the authorized Liat Influenza A/2009 H1N1 Assay for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.

The Authorized Liat Influenza A/2009 H1N1 Assay:

The Liat Influenza A/2009 H1N1 Assay is a rapid, automated multiplex real-time RT-PCR assay intended for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate complexity tests and in laboratories certified under CLIA to perform high complexity tests using the Liat Analyzer for the in vitro qualitative detection of influenza A virus and differentiation of 2009 H1N1 influenza viral RNA. The Liat Influenza A/2009 H1N1 Assay uses nasopharyngeal swab (NPS) specimens collected from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The assay targets a conserved region of the matrix gene of Influenza A viral RNA (Inf A target) and the hemagglutinin gene of 2009 H1N1 Influenza viral RNA (2009 H1N1 target). An Internal Process Control (IPC) is also included. The IPC is present to control for adequate processing of the target viruses and to monitor the presence of inhibitors in the RT-PCR reactions.

The Liat Influenza A/2009 H1N1 Assay is performed on the lab-in-a-tube technology platform. The system consists of a disposable Liat Influenza A/H1N1Assay Tube and the Liat Analyzer. The Liat Tube uses a flexible tube as a sample vessel. It contains all required unit dose reagents pre-packed in tube segments, separated by peelable seals, in the order of reagent use. The Liat Analyzer performs all assay steps from raw sample and report assay result automatically. During the testing process, multiple processing actuators of the analyzer compress the Liat Tube to selectively release reagents from tube segments, move the sample from one segment to another, and control reaction volume, temperature and time to conduct sample preparation, nucleic acid extraction, target enrichment, inhibitor removal, nucleic acid elution and real-time RT-PCR. An embedded microprocessor controls and coordinates the actions of these sample processors to perform all required assay processes within the closed Liat Tube.

The Liat Influenza A/2009 H1N1 Assay includes the following primer and probe sets:

  • InfA: A single primer pair and probe were designed to recognize a conserved region of the matrix gene of Influenza A viral RNA. The specific probe for InfA is detected at 525 nm.
  • 2009 H1N1: Three primer pairs and two probes were designed to specifically detect a region of the hemagglutinin gene of 2009 H1N1 Influenza viral RNA but not react with other Influenza A strains of swine origin. Each of the probes for 2009 H1N1 are labeled with the same reporter dye allowing for detection at 630 nm.
  • IPC (Internal Process Control): MS2 bacteriophage is pre- packed in each Liat tube. When conducting an assay, it is first mixed with sample and then goes through all the test process to monitor both the sample extraction process and RT-PCR reaction performance. The sample tube contains a primer pair and probe specifically designed for detection of a region of MS2 bacteriophage genome. The reporter probe for the IPC is labeled with a reporter dye that allows for detection at 710 nm.

The Liat Influenza A/2009 H1N1 Assay RNA also uses the following control materials:

  • Liat Influenza A/2009 H1N1 Assay External Positive/Negative Control Kit (Cat # 20-03628, IQuum) and Liat Influenza Assay Quality Control Kit (Cat# 20-03643)
    • External Negative Control consists of Liat Swab Dilution Buffer. The negative control is run during the “add lot” process and is used to assess Liat sample tube validity and performance. Additional runs of the negative control can be run to determine if there is contamination resulting in false positive results.
    • External Positive Control of the assay is provided by the Liat Influenza A/2009 H1N1 Positive Control Tube. This sample is also run during the “add-lot’ process and is used to assess Liat sample tube validity and performance. This control also ensures that the instrument is functioning as intended.

The Liat Influenza A/2009 H1N1 Assay requires the following hardware:

  • Liat Analyzer

The Liat Influenza A/2009 H1N1 Assay requires the use of the following additional reagents/materials:

  • Liat Influenza A/2009 H1N1 Assay Tube (Cat # 20-03701, IQuum)
  • Liat NP Swab Collection Kit (Liat Dilution Buffer) (Cat # 20-03641, IQuum)
  • Liat NP Swab Collection Kit (UTM) (Cat # 20-03642, IQuum)

The above described Liat Influenza A/2009 H1N1 Assay , when labeled consistently with the labeling authorized by FDA, entitled Liat Influenza A/2009 H1N1 Assay 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 distributed to and used by CLIA High Complexity and Moderate Complexity Laboratories, under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.

The above described Liat Influenza A/2009 H1N1 Assay 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 the Liat Influenza A/2009 H1N1 Assay Results
  • Fact Sheet for Patients: Understanding the Liat Influenza A/2009 H1N1 Assay Results

As described in section IV below, IQuum is also authorized to make available additional information relating to the emergency use of the authorized Liat Influenza A/2009 H1N1 Assay 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 Liat Influenza A/2009 H1N1 Assay 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 Liat Influenza A/2009 H1N1 Assay 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 Liat Influenza A/2009 H1N1 Assay, 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 Liat Influenza A/2009 H1N1 Assay 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 Liat Influenza A/2009 H1N1 Assay 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 Liat Influenza A/2009 H1N1 Assay 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 Liat Influenza A/2009 H1N1 Assay.
  • 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:

IQuum

  1. IQuum will distribute the authorized Liat Influenza A/2009 H1N1 Assay with the authorized labeling, as may be revised with written permission of FDA, only to CLIA High Complexity or Moderate Complexity Laboratories.
  2. IQuum will provide to the CLIA High Complexity and Moderate Complexity Laboratories the authorized Liat Influenza A/2009 H1N1 Assay Fact Sheet for Healthcare Providers and the authorized Liat Influenza A/2009 H1N1 Assay Fact Sheet for Patients.
  3. IQuum will make available on its website the authorized Liat Influenza A/2009 H1N1 Assay Fact Sheet for Healthcare Providers and the authorized Liat Influenza A/2009 H1N1 Assay Fact Sheet for Patients.
  4. IQuum will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.
  5. All advertising and promotional descriptive printed matter relating to the use of the authorized Liat Influenza A/2009 H1N1 Assay 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.
  6. All advertising and promotional descriptive printed matter relating to the use of the authorized Liat Influenza A/2009 H1N1 Assay shall clearly and conspicuously state that:
    • This test has not been FDA cleared or approved;
    • FDA has not determined that this test may be performed in settings with certificates of waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a;
    • This test has been authorized by FDA under an Emergency Use Authorization;
    • This test has been authorized only for the diagnosis of 2009 H1N1 influenza virus and not for the diagnosis of 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), unless the authorization is revoked sooner; and
    • The declaration of emergency will expire on June 23, 2010, unless it is terminated sooner or renewed.
  7. No advertising or promotional descriptive printed matter relating to the use of the authorized Liat Influenza A/2009 H1N1 Assay may represent or suggest that this test is safe or effective for the diagnosis of 2009 H1N1 influenza virus.
  8. IQuum will ensure that CLIA High Complexity and Moderate Complexity Laboratories using the authorized Liat Influenza A/2009 H1N1 Assay have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as appropriate.
  9. IQuum will track adverse events and report to FDA as required under 21 CFR part 803.
  10. Through a process of inventory control, IQuum will maintain records of device usage.
  11. IQuum 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 IQuum becomes aware.
  12. IQuum is authorized to make available additional information relating to the emergency use of the authorized Liat Influenza A/2009 H1N1 Assay that is consistent with, and does not exceed, the terms of this letter of authorization.
  13. Only IQuum may request changes to the authorized Liat Influenza A/2009 H1N1 Assay Fact Sheet for Healthcare Providers or the authorized Liat Influenza A/2009 H1N1 Assay Fact Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and approval.

CLIA High Complexity and Moderate Complexity Laboratories

  1. CLIA High Complexity and Moderate Complexity Laboratories will include with reports of the results of the Liat Influenza A/2009 H1N1 Assay the authorized Fact Sheet for Healthcare Providers and the authorized Fact Sheet for Patients.
  2. CLIA High Complexity and Moderate Complexity Laboratories will perform the assay on the Liat system.
  3. CLIA High Complexity and Moderate 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.
  4. CLIA High Complexity and Moderate Complexity Laboratories will collect information on the performance of the assay, and report to IQuum any suspected occurrence of false positive or false negative results of which CLIA High Complexity and Moderate Complexity Laboratories become aware.
  5. CLIA High Complexity and Moderate Complexity Laboratories will clearly and conspicuously state on reports of the results of the Liat Influenza A/2009 H1N1 Assay 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.

IQuum and CLIA High Complexity and Moderate Complexity Laboratories

  1. IQuum and CLIA High Complexity and Moderate Complexity 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 Liat Influenza A/2009 H1N1 Assay 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.