The QuickVue Influenza A+B test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, nasal aspirate, and nasal wash specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and type B viral infections. The test is not intended to detect influenza C antigens. Negative results should be confirmed by cell culture; they do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

Device Description

Nasal swabs, nasopharyngeal swabs, nasal wash and/or nasal aspirates serve as specimens for this test. The patient specimen is placed in a tube containing Extraction Reagent, during which time the virus particles in the specimen are disrupted, exposing internal viral antigens. After extraction, the Test Strip is placed in the Extraction Tube for 10 minutes. During this time, the extracted specimen will react with the reagents in the Test Strip. If the extracted specimen contains influenza Type A and/or B antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the test Strip. If influenza Type A and B viral antigens are not present, or present at very low levels, only a blue procedural Control Line will appear. If no blue procedural Control Line develops, the result is considered invalid.

AI/ML Overview

The provided text describes the QuickVue Influenza A+B test, a lateral-flow immunoassay for the rapid, qualitative detection of influenza type A and B antigens. However, the document does NOT contain information about specific acceptance criteria or an overarching study proving the device meets those criteria in terms of clinical performance (sensitivity, specificity) with real patient samples. The summary focuses on comparing the proposed device to a predicate device and an analytical study rather than a clinical one.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., minimum sensitivity or specificity targets) or report clinical performance metrics against such criteria. The "Summary of Performance Data" section describes an analytical study, not a clinical one, and its conclusion refers to the minimum detectable level of cultured viruses.

Acceptance Criteria (Not explicitly stated for clinical performance)	Reported Device Performance (Analytical Study)
Clinical Sensitivity: Not stated	Detects 2009 H1N1 (California/04/2009)
Clinical Specificity: Not stated	Reactivity to cultured strain of 2009 H1N1 Influenza A virus
Minimum Detectable Level: Not stated	1.63 X 10^3 TCID50/ml for 2009 H1N1 Influenza A virus
Ability to distinguish A/B: Not stated	Can distinguish between influenza A and B viruses
Ability to differentiate subtypes: Not stated	Cannot differentiate influenza subtypes

The document clearly states: "Although this test has been shown to detect the 2009 H1N1 virus cultured from a positive human respiratory specimen, the performance characteristics of this device with clinical specimens that are positive for the 2009 H1N1 influenza virus have not been established." This indicates a lack of clinical study data at the time of this filing.

2. Sample Size Used for the Test Set and Data Provenance

The only described study is an analytical study using "cultured viruses."

Sample Size for Test Set: Not specified, as it's an analytical study with cultured viruses rather than a clinical test set. The study uses "cultured viruses" of specific H1N1 strains.
Data Provenance: The study uses "cultured viruses" (seasonal H1N1 (New Caledonia/20/1999) and 2009 H1N1 (California/04/2009)). This is laboratory-derived data, not human patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable, as the study described is an analytical sensitivity study using cultured viral strains, not a clinical study requiring expert ground truth establishment from patient samples.

4. Adjudication Method for the Test Set

Not applicable, as the study described is an analytical sensitivity study using cultured viral strains, not a clinical study requiring adjudication of patient results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states that the performance characteristics with clinical specimens have not been established. The study mentioned is an analytical sensitivity study with cultured viruses, not involving human readers or comparative effectiveness.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the described "analytical study" involving cultured viruses to determine the "minimum detectable level" of the QuickVue Influenza A+B test is a standalone performance assessment of the device's ability to detect viral antigens in a controlled laboratory setting. This is a characteristic of a standalone test, as it's measuring the device's intrinsic detection capability.

7. The Type of Ground Truth Used

The ground truth for the analytical study was the presence and concentration (TCID50/ml) of specific cultured viral strains (seasonal H1N1 and 2009 H1N1).

8. The Sample Size for the Training Set

Not applicable. This device is a lateral-flow immunoassay, not a machine learning or AI-based device that typically requires a training set. The "study" described is an analytical validation.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of diagnostic device.

Summary

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SEP 1 5 2009

510(k) SUMMARY

Submitted By:

Quidel Corporation 10165 McKellar Court San Diego, California 92121 Telephone: 858-552-7908 Fax: 858-646-8045

Submission Contact:

Date Prepared:

Device Trade Name:

Common Name:

Predicate Device:

Product Code:

Device Classification/Name:

John D. Tamerius

September 1, 2009

QuickVue® Influenza A+B

Influenza Test

QuickVue Influenza A+B (K031899 and K053146)

GNX

21 CFR 866.3330 / Influenza virus serological reagents.

The device, the QuickVue Influenza A+B test, is similar to other FDA-cleared devices used for the qualitative detection of influenza type A and B directly from clinical specimens. These tests are used to aid in the diagnosis of disease caused by influenza viruses A and B and provide epidemiological information on these diseases (21 CFR 866.3330).

The Food and Drug Administration has classified serological test systems for the detection of influenza virus as Class I.

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Intended Use:

Physiologic Basis of the Test:

Inflyenza is a highly contagious, acute, viral infection of the respiratory tract. The causative agents of the disease are immunologically diverse, single-strand RNA viruses known as Influenza Viruses. There are three types of influenza viruses: A, B, and C. Type A viruses are the most prevalent and are associated with the most serious epidemics. Type B produces a disease that is generally milder than that caused by Type A. Type C has never been connected with a large epidemic of human disease. Both Type A and B viruses can circulate simultaneously, but usually one type is dominant during a given season.

Influenza antigens may be detected in clinical specimens by immunoassay. The QuickVue Influenza A+B test is a lateral-flow immunoassay using highly sensitive monoclonal antibodies that are specific for influenza antigens. The test is specific to influenza Types A and B antigen with not known cross-reactivity to normal flora or other known respiratory pathogens.

The QuickVue Influenza A+B test, has two Test Line indicators - one for type A and one for type B. The two Test Line indicators allow for the separate identification of type A and type B viral antigens from the same specimen. If either Test Line turns pink-to-red, the test is positive for influenza.

Device Description:

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If the extracted specimen contains influenza Type A and/or B antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the test Strip. If influenza Type A and B viral antigens are not present, or present at very low levels, only a blue procedural Control Line will appear. If no blue procedural Control Line develops, the result is considered invalid.

Features	QuickVue Influenza A+B(Proposed)	QuickVue Influenza A+B(K031899 and K053146)
Intended Use	The QuickVue Influenza A+B testallows for the rapid, qualitativedetection of influenza type A andtype B antigens directly from nasalswab, nasopharyngeal swab, nasalaspirate, and nasal wash specimens.The test is intended for use as an aidin the rapid differential diagnosis ofacute influenza type A and type Bviral infections. The test is notintended to detect influenza Cantigens. Negative results should beconfirmed by cell culture; they do notpreclude influenza virus infection andshould not be used as the sole basisfor treatment or other managementdecisions. The test is intended forprofessional and laboratory use.	The QuickVue Influenza A+B testallows for the rapid, qualitativedetection of influenza type A andtype B antigens directly from nasalswab, nasopharyngeal swab, nasalaspirate, and nasal wash specimens.The test is intended for use as an aidin the rapid differential diagnosis ofacute influenza type A and type Bviral infections. The test is notintended to detect influenza Cantigens. Negative results should beconfirmed by cell culture; they do notpreclude influenza virus infection andshould not be used as the sole basisfor treatment or other managementdecisions. The test is intended forprofessional and laboratory use.
Specimen Types	Nasal swab, nasopharyngealswab, nasal aspirate, and nasalwash specimens	Nasal swab, nasopharyngealswab, nasal aspirate, and nasalwash specimens
Read Result Time	10 minutes	10 Minutes
Format	Lateral-flow immunoassay	Lateral-flow immunoassay

Device Comparison:

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Device Comparison (cont.):

Features	QuickVue Influenza A+B (Proposed)	QuickVue Influenza A+B (K031899 and K053146)
Detection ofInfluenza Virus	Detection of Influenza type A andtype B	Detection of Influenza type A andtype B
Extraction	1 step; buffer and detergent	1 step; buffer and detergent

Summary of Performance Data:

· An analytical study was performed with cultured viruses to determine the analytical sensitivity or minimum detectable level of the QuickVue Influenza A+B for cultured strains of seasonal H1N1 (New Caledonia/20/1999) and 2009 H1N1 (California/04/2009).

Conclusion:

The results of this study show that QuickVue Influenza A+B shows reactivity to the cultured strain of 2009 H1N1 Influenza A virus (Californial04/2009) with a minimum detectable level of 1.63 X 103 TCID50/ml. Although this test has been shown to detect the 2009 H1N1 virus cultured from a positive human respiratory specimen, the performance characteristics of this device with clinical specimens that are positive for the 2009 H1N1 influenza virus have not been established. The QuickVue Influenza A+B test can distinguish between influenza A and B viruses, but it can not differentiate influenza subtypes.

The QuickVue Influenza A+B is substantially equivalent with the current QuickVue Influenza A+B test.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, topped with a single wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

SEP 1 5 2009

John D. Tamerius, PhD. Senior Vice President, Clinical and Regulatory Affairs Quidel Corporation 10165 McKellar Court San Diego, CA 92121

Re: K092698

Trade/Device Name: QuickVue Influenza A+B Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza Virus Serological Reagents Regulatory Class: Class I Product Code: GNX Dated: September 1, 2009 Received: September 2, 2009

Dear Dr. Tamerius:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or

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any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sally atyme

Sally A. Hojvat, Ph.D. Director, Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if knówn):

K092698

Device Name:

QuickVue® Influenza A+B test

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off	Um Schl
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Office of In Vitro Diagnostic Device Evaluation and Safety

Page	1 of 1
510(k)	K092698

Regulation Number and Section

§ 866.3328 Influenza virus antigen detection test system.

(a)
Identification. An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection. The test aids in the diagnosis of influenza infection and provides epidemiological information on influenza. Due to the propensity of the virus to mutate, new strains emerge over time which may potentially affect the performance of these devices. Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health implications.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device's sensitivity and specificity performance characteristics or positive percent agreement and negative percent agreement, for each specimen type claimed in the intended use of the device, must meet one of the following two minimum clinical performance criteria:
(i) For devices evaluated as compared to an FDA-cleared nucleic acid based-test or other currently appropriate and FDA accepted comparator method other than correctly performed viral culture method:
(A) The positive percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The negative percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(ii) For devices evaluated as compared to correctly performed viral culture method as the comparator method:
(A) The sensitivity estimate for the device when testing for influenza A must be at the point estimate of at least 90 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 80 percent. The sensitivity estimate for the device when testing for influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The specificity estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(2) When performing testing to demonstrate the device meets the requirements in paragraph (b)(1) of this section, a currently appropriate and FDA accepted comparator method must be used to establish assay performance in clinical studies.
(3) Annual analytical reactivity testing of the device must be performed with contemporary influenza strains. This annual analytical reactivity testing must meet the following criteria:
(i) The appropriate strains to be tested will be identified by FDA in consultation with the Centers for Disease Control and Prevention (CDC) and sourced from CDC or an FDA-designated source. If the annual strains are not available from CDC, FDA will identify an alternative source for obtaining the requisite strains.
(ii) The testing must be conducted according to a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(iii) By July 31 of each calendar year, the results of the last 3 years of annual analytical reactivity testing must be included as part of the device's labeling. If a device has not been on the market long enough for 3 years of annual analytical reactivity testing to have been conducted since the device received marketing authorization from FDA, then the results of every annual analytical reactivity testing since the device received marketing authorization from FDA must be included. The results must be presented as part of the device's labeling in a tabular format, which includes the detailed information for each virus tested as described in the certificate of authentication, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where the analytical reactivity testing data can be found; or
(B) In the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.
(4) If one of the actions listed at section 564(b)(1)(A)-(D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services (HHS) determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain:
(i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate. The procedure and location of testing may depend on the nature of the emerging virus.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or
(B) In a section of the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.