The QuickVue Influenza A/B Test is intended for the rapid, qualitative detection of influenza Types A and B antigen directly from nasal swab, nasal wash and/or nasal aspirate specimens. The test is intended for use as an aid in the rapid diagnosis of acute influenza virus infection. The test is intended for professional and laboratory use.

Device Description

The QuickVue Influenza A/B Test is a lateral-flow immunoassay using highly sensitive moroclonal antibodies that are specific for influenza antigens. The test is specific to influenza Types A and B antigen with no know cross-reactivity to normal flora or other known respiratory pathogens.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the QuickVue Influenza A/B Test based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values (e.g., "sensitivity must be >90%"). Instead, it describes demonstrating "substantial equivalence" to viral culture. The reported performance is based on exceeding a general benchmark of agreement for laboratory personnel.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred/Stated)	Reported Device Performance
Clinical Performance	Substantial equivalence to viral culture for qualitative detection of Influenza Type A and B antigens.	Demonstrated in a multi-clinical field study. (Specific metrics like sensitivity/specificity are not provided in this summary document, only the conclusion of substantial equivalence).
User Performance	Doctors' office personnel with diverse educational backgrounds and work experience can perform the test accurately and reproducibly.	>99% agreement with expected results in Physician's Office Laboratory (POL) studies.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Two distinct studies are mentioned:
  - A "multi-clinical field study" for substantial equivalence to viral culture. The exact number of clinical specimens or patients is not provided.
  - "Physician's Office Laboratory studies" conducted at three geographically distinct sites in the United States. The exact number of tests performed or samples used in these POL studies is not provided.
- Data Provenance:
  - Clinical specimens obtained from patients symptomatic for upper respiratory infection.
  - POL studies were conducted in the United States at three geographically distinct sites.
  - Both studies appear to be prospective, as they compare the QuickVue test to viral culture or assess user performance in real-time settings.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The primary ground truth for the clinical performance study was viral culture. The document does not specify the number or qualifications of experts interpreting the viral culture results. Viral culture itself is considered a gold standard in this context, and interpretation is typically handled by trained laboratory personnel or virologists, though this is not explicitly stated.
- For the POL studies, "expected results" were used, implying a reference standard, but the origin or expert involvement in establishing these "expected results" is not detailed.
Adjudication method for the test set:
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for resolving discrepancies between the QuickVue test and the reference standard (viral culture). It simply states a "comparison" was conducted.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a rapid diagnostic test (lateral-flow immunoassay), not an AI-based diagnostic requiring human reader assistance. The "user performance" study focused on the ability of doctors' office personnel to perform the test accurately, not on their improvement with technological assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the QuickVue Influenza A/B Test operates as a standalone device. Its performance is evaluated intrinsically through comparison to a reference standard (viral culture) for antigen detection. There is no "human-in-the-loop" component in the sense of a software algorithm assisting a human interpreter; the human conducts and reads the test directly.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical performance study, the primary ground truth was viral culture. This is a laboratory-based diagnostic method considered a gold standard for influenza detection.
The sample size for the training set:
- The document does not provide details on a separate "training set" or its sample size. For an immunoassay like this, the development typically involves extensive assay optimization and validation during R&D using various characterized samples, rather than a distinct "training set" in the machine learning sense. The clinical studies described are for validation of the final product.
How the ground truth for the training set was established:
- As no explicit "training set" is described in the provided text for this immunoassay, how its ground truth was established is not detailed. However, for immunoassay development, ground truth for optimization would typically come from well-characterized clinical samples (e.g., confirmed positive/negative by PCR or viral culture) or spiked samples with known amounts of antigen.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS XI.

The following information as presented in the Premarket Notification [510(k)] for the QuickVue Influenza A/B Test constitutes data supporting a substantially equivalent determination.

Product:

QuickVue® Influenza A/B Test

Manufacturer:

QUIDEL Corporation 10165 McKellar Court San Diego, California 92121

Device Classification:

The device, 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 cause by influenza viruses A and B and provide epidemiological information on these diseases (21CFR 866.3330).

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

Intended Use:

Physiologic Basis for the Test:

Influenza 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.

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Influenza antigens may be detected in clinical specimens by immunoassay. The QuickVue Influenza A/B Test is a lateral-flow immunoassay using highly sensitive moroclonal antibodies that are specific for influenza antigens. The test is specific to influenza Types A and B antigen with no know cross-reactivity to normal flora or other known respiratory pathogens.

Principle of the Test:

Nasal 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-tored 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.

Safety and Effectiveness:

Substantial equivalence has been demonstrated between the QuickVue Influenza A/B Test and viral culture for the qualitative detection of influenza Type A and B antigens. Using clinical specimens obtained from patients symptomatic for upper respiratory infection, a comparison of the QuickVue Influenza A/B Test to viral culture was conducted in a multi-clinical field study.

Physician's Office Laboratory studies were also conducted to show that doctors' office personnel with diverse educational backgrounds and work experience can perform the test accurately and reproducibly. Testing was performed at three geographically distinct sites in the United States. The results obtained at each site agreed >99% with the expected results.

Conclusion:

These studies demonstrated the substantial equivalence of the QuickVue Influenza A/B Test to existing products already marketed. They further demonstrated the suitability of the product for laboratory and professional use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

SEP 2 4 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Mary De Armond Regulatory Compliance Manager Quidel Corporation 10165 McKellar Court San Diego, California 92121

Re: K991633 Trade Name: QuickVue® Influenza A/B Test Regulatory Class: I Product Code: GNX Dated: August 10, 1999 Received: August 17, 1999

Dear Ms. De Armond:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use (Separate Page) XIII.

of ۳ Page

510(k) Number (if known):

Device Name:

QuickVue® Influenza A/B Test

K991633

Indications for Use:

The QuickVue Influenza A/B Test is intended for the qualitative detection of influenza Type A and Type B antigens directly from nasal swab, nasal wash and nasal aspirate specimens. The QuickVue Influenza A/B Test is intended for laboratory and professional use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubose

I I ahoratory Devic 510(k) Number

Prescription Use	X
(Per 21 CFR 801.109)

OR-

Over-The Counter Use____________

Quidel Corporation 10165 McKellar Court · San Diego, CA 92121 (619) 552-1100 ▪ FAX (619) 453-4338

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.