The QuickVue Influenza A + B test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasal wash and nasal aspirate 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. The test is intended for professional and laboratory use.

Device Description

The QuickVue Influenza A + B test, the successor product to the QuickVue Influenza 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 pinkto-red, the test is positive for influenza. 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-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

Here's a breakdown of the acceptance criteria and study information for the QuickVue® Influenza A + B test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state pre-defined acceptance criteria (e.g., a specific sensitivity or specificity percentage target). Instead, it states that "Substantial equivalence has been demonstrated between the QuickVue test and viral culture for the qualitative detection of influenza Type A and B antigens." This implies that the device's performance, as measured in comparison to viral culture, was deemed acceptable by the FDA for establishing substantial equivalence to predicate devices.

However, the specific quantitative performance metrics (sensitivity, specificity) from the clinical study are not provided in this summary.

Acceptance Criteria (Implied)	Reported Device Performance (Relative to Viral Culture)
Sufficient agreement with viral culture for qualitative detection of influenza A and B antigens to demonstrate substantial equivalence to predicate devices.	"Substantial equivalence has been demonstrated between the QuickVue test and viral culture for the qualitative detection of influenza Type A and B antigens." (Specific metrics not provided in summary)

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

Sample Size for Test Set: Not explicitly stated in the provided text. The text mentions a "multi-clinical field study" but does not give the number of clinical specimens.
Data Provenance:
- Country of Origin: Not explicitly stated.
- Retrospective or Prospective: Retrospective. The text states: "a retrospective comparison of the QuickVue Influenza A + B test to viral culture was conducted in a multi-clinical field study."

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

This information is not provided in the document. The ground truth was established by "viral culture." The qualifications of those performing or interpreting the viral culture are not specified.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done? No. This type of study is not mentioned. The device is a "standalone" or "algorithm only" type of diagnostic, meaning human interpretation is based on the visible lines on the test strip, not assisted by an AI.
Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as no AI assistance is mentioned.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was it done? Yes, implicitly. The QuickVue® Influenza A + B test is a lateral-flow immunoassay, which is a standalone device providing a direct result (pink-to-red test line, blue control line) without human-in-the-loop AI assistance. The clinical study evaluated the performance of this device on its own.

7. Type of Ground Truth Used

Ground Truth: Viral culture. The text states: "Substantial equivalence has been demonstrated between the QuickVue test and viral culture..."

8. Sample Size for the Training Set

This information is not provided in the document. As this is an immunoassay and not an AI/machine learning device, the concept of a "training set" in the context of data for model development is typically not applicable. The device's "training" would be its design and optimization during manufacturing and R&D phases.

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

Not applicable, as a "training set" for an AI/ML model is not relevant for this immunodiagnostic device.

Summary

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SEP 1 1 2003

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Assigned 510(k) Number:	K031899
Submitted By:	Quidel Corporation10165 McKellar CourtSan Diego, California 92121Telephone: 858-552-7908Telefax: 858-646-8045
Submission Contact:	Robin Weiner
Date Prepared:	June 27, 2003
Device Trade Name:	QuickVue® Influenza A + B test
Predicate Devices:	Quidel QuickVue® Influenza test (K991633)BD Directigen™ Flu A+B test (K001364)BioStar® AB Flu OIA® test (K023556)
Device Classification:	21 CFR 866.3330The device, the QuickVue Influenza A + B test,is similar to other FDA-cleared devices usedfor the qualitative detection of influenza type Aand B directly from clinical specimens. Thesetests are used to aid in the diagnosis ofdisease cause by influenza viruses A and Band provide epidemiological information onthese diseases (21CFR 866.3330).The Food and Drug Administration hasproposed that serological test systems for thedetection of influenza virus be classified asClass I.
Intended Use:	The QuickVue Influenza A + B test allows forthe rapid, qualitative detection of influenza typeA and type B antigens directly from nasalswab, nasal wash and nasal aspiratespecimens. The test is intended for use as anaid in the rapid differential diagnosis of acuteinfluenza type A and type B viral infections.The test is not intended to detect influenza Cantigens. The test is intended for professionaland laboratory use.

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Physiologic Basis of 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.
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 no know cross-reactivity to normal flora or other known respiratory pathogens.
Device Description: The QuickVue Influenza A + B test, the successor product to the QuickVue Influenza 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 pinkto-red, the test is positive for influenza.
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.

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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.

Device Comparison:

Features	QuickVue®Influenza A+Btest	QuickVue®Influenza test	BDDirectigen™Flu A+B	BioStar®AB Flu OIA®test
IntendedUse	Differentialdetection ofinfluenza A and Bviral antigen	Detection ofinfluenza A andB viral antigen	Direct andqualitativedetection ofinfluenza A andB viral antigen	Qualitative,rapid detectionof influenza Aand B viralantigen(nucleoprotein)
SpecimenTypes	Nasal SwabNasal WashNasal Aspirate	Nasal SwabNasal WashNasal Aspirate	NasopharyngealWashesNasopharyngealSwabsNasopharyngealAspiratesThroat SwabsLower NasalSwabsBronchoalveolarLavages	Nasal AspiratesNasopharyngealSwabsThroat SwabsSputum
Technology	Lateral-flowimmunoassay	Lateral-flowimmunoassay	Enzymeimmunoassay	Opticalsandwichimmunoassay
Detection ofInfluenzaVirus	Detection ofInfluenza type Aand type B	Differentiateddetection ofInfluenza typeA and type B	Differentiateddetection ofInfluenza type Aand type B	Differentiateddetection ofInfluenza type Aand type B
Extraction	1 step; buffer anddetergent	1 step; bufferand detergent	1 step;detergent	2 steps;detergent andreducing agent

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Summary of Performance Data:

Clinical Studies

Substantial equivalence has been demonstrated between the QuickVue 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 retrospective comparison of the QuickVue Influenza A + B test to viral culture was conducted in a multi-clinical field study.

Analytical Studies

Analytical testing, including analytical sensitivity, specificity, cross-reactivity and interference were conducted. These studies 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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Public Health Service

Image /page/4/Picture/2 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged around the circumference. Inside the circle is a stylized symbol resembling an abstract bird in flight, composed of four curved lines. The logo is presented in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 1 2003

Ms. Robin Weiner Vice President, Clinical and Regulatory Affairs Quidel Corporation 10165 McKellar Court San Diego, CA 92121

K031899 Re:

Trade/Device Name: QuickVue® Influenza A+B Test Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza Virus Serological Reagents Regulatory Class: Class I Product Code: GNX Dated: June 3. 2003 Received: June 25, 2003

Dear Ms. Weiner:

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 either class II (Special Controls) or class III (PMA), 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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

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510(k) Number (if known):

K031899

Device Name:

QuickVue® Influenza A+B test

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off	9/11/03
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Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k)	K031899
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Prescription Use(Per 21 CFR 801.109)	OR	Over-The Counter Use
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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.