The QuickVue® RSV test allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) directly from nasopharyngeal swab, nasopharyngeal aspirate and/or nasal wash specimens for symptomatic patients eighteen years of age and younger. The test is intended for use as an aid in the rapid diagnosis of acute respiratory syncytial viral infections. Negative test results should be confirmed by cell culture. The test is intended for professional and laboratory use.

Device Description

Nasopharyngeal swabs, nasopharyngeal aspirate and/or nasal washes 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 15 minutes. During this time, the extracted specimen will react with the reagents in the Test Strip. If the extracted specimen contains RSV antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip. If RSV 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® RSV test," a lateral-flow immunoassay designed for the rapid, qualitative detection of respiratory syncytial virus (RSV) directly from nasopharyngeal swab, aspirate, and/or nasal wash specimens in symptomatic patients 18 years of age and younger.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific sensitivity and specificity thresholds. However, it implicitly uses "substantial equivalence" to a legally marketed predicate device (Binax NOW® RSV Test) as the primary criterion for acceptance.

Performance Metric	QuickVue® RSV Test Performance (vs. Viral Culture)	Predicate Device (Binax NOW® RSV Test)	Acceptance Criterion Implied
Sensitivity	Reported as "excellent agreement" in a clinical performance study with frozen nasal washes compared to the predicate device. For the multi-center field clinical study comparing to viral culture, the specific percentage is not provided, but the conclusion is that the studies "demonstrated the substantial equivalence."	Not explicitly provided in quantifiable terms in this document.	Substantial equivalence to the predicate device.
Specificity	Reported as "excellent agreement" in a clinical performance study with frozen nasal washes compared to the predicate device. For the multi-center field clinical study comparing to viral culture, the specific percentage is not provided, but the conclusion is that the studies "demonstrated the substantial equivalence."	Not explicitly provided in quantifiable terms in this document.	Substantial equivalence to the predicate device.
Overall Accuracy	Calculated in multi-center field clinical study, but specific percentages are not provided.	Not explicitly provided in quantifiable terms in this document.	Substantial equivalence to the predicate device.

Note: The document states "Sensitivity, specificity and overall accuracy were calculated using nasopharyngeal aspirates and nasopharyngeal swabs compared to viral culture" in the multi-center field clinical study, but the actual numerical results are not included in this summary.

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

The document does not explicitly state the specific sample sizes used for the test sets in the performance studies.

Multi-center field clinical study: Conducted to determine sensitivity, specificity, and overall accuracy. The number of centers and overall patient count are not specified.
Clinical performance study with frozen nasal washes: Used to demonstrate agreement with the predicate device. The sample size for this study is not specified.
Data Provenance: The document implies the data is gathered via clinical studies, which are typically prospective in nature, but this is not explicitly stated. The country of origin for the data is not specified.

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

The primary ground truth for the multi-center field clinical study was viral culture. This is a laboratory-based method, not reliant on human expert interpretation in the same way as, for example, reading medical images. Therefore, the concept of "experts" to establish ground truth as typically understood in AI/ML performance studies (e.g., radiologists, pathologists) is not directly applicable here for the primary ground truth.

For the comparison with the predicate device, the predicate device itself served as a reference in some capacity, but viral culture was the ultimate arbiter for accuracy.

4. Adjudication Method for the Test Set

Since the primary ground truth was viral culture, an objective laboratory method, an adjudication method for human expert disagreement (like 2+1 or 3+1) is not relevant. The viral culture result would be considered definitive.

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

No, there is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. This device is a diagnostic test kit, not an AI-assisted diagnostic tool for human readers.

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

Yes, the studies described are based on the standalone performance of the QuickVue® RSV test. The test itself is a lateral-flow immunoassay that provides a visible result (color change or line appearance). The performance studies evaluate the accuracy of this test result against a ground truth (viral culture or predicate device). There is no "human-in-the-loop" component in the interpretation of the output of the device itself; the outcome of the test (positive/negative line) is read directly. However, the application of the test is for professional and laboratory use, implying human operation and interpretation of the physical test result.

7. The Type of Ground Truth Used

Multi-center field clinical study: Viral culture
Clinical performance study with frozen nasal washes: Comparison to a predicate device (Binax NOW® RSV Test), implicitly using the predicate as a reference or a secondary ground truth, though viral culture is the gold standard for RSV detection.

8. The Sample Size for the Training Set

This document describes a diagnostic test kit (immunoassay) developed using traditional scientific and engineering methods, not a machine learning or AI model. Therefore, the concept of a "training set" for an algorithm is not applicable. The development of the test involves antibody selection, assay optimization, and manufacturing processes, but not machine learning model training.

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

As noted above, this is an immunoassay device, not an AI/ML algorithm. Thus, there is no "training set" or "ground truth for the training set" in the context of machine learning. The specificity of the monoclonal antibodies used in the test would be established through laboratory validation against known RSV strains and other pathogens/flora during the development phase.

Summary

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Koloa08

510(k) SUMMARY

Submitted By:

Quidel Corporation 10165 McKellar Court San Diego, California 92121 408-690-4938 Cell: Telephone: 415-664-4904 858-646-8045 Fax:

John D. Tamerius, Ph.D.

QuickVue® RSV test

SEP - 8 2006

Submission Contact:

Date Prepared:

Device Trade Name:

Respiratory syncytial Virus (RSV) Test Common Name:

Binax NOW® RSV Test (K032166) Predicate Device:

21 CFR 866.3480 / Respiratory syncytial virus Device Classification/Name: serological reagents.

April 11, 2006

The device, the QuickVue® RSV test, is similar to other FDA-cleared devices used for the qualitative detection of RSV directly from clinical specimens. These tests are used to aid in the diagnosis of disease caused by respiratory syncytial viruses and provides epidemiological these diseases (21CFR on information 866.3480). The Food and Drug Administration has classified serological test systems for the detection of respiratory syncytial virus as Class 1.

Intended Use:

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Physiologic Basis of the Test:

Respiratory syncytial virus (RSV) is a single stranded (negative strand) RNA virus of the Paramyxoviridae family. It is the causative agent of a highly contagious, acute, viral infection of the respiratory tract. RSV infection is recognized as the leading cause of hospitalization of children during the first year of life. It is also the major viral cause of nosocomial illness in children already hospitalized for other reasons. Half of all infants become infected during their first year of life. Virtually all have been infected by their second year. Infection involving the lower respiratory tract carries an associated mortality rate of 0.5%, especially in premature infants or infants and children with underlying lung disease. There is a need for rapid diagnosis of RSV. This can lead to more effective care and management of these patients.

RSV causes approximately 100,000 hospitalizations and as many as 4,500 deaths in the U.S. each year. Recently, it has become more apparent that RSV is an important pathogen for the elderly and in the immunocompromised patient.

The QuickVue® RSV test is a lateral-flow immunoassay using highly sensitive monoclonal antibodies that are specific for RSV antigens. The test is specific to RSV antigen with no known cross-reactivity to normal flora or other known respiratory pathogens.

Device Description: Nasopharyngeal swabs, nasopharyngeal aspirate and/or nasal washes 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 After extraction, the Test Strip is antigens. placed in the Extraction Tube for 15 minutes. During this time, the extracted specimen will react with the reagents in the Test Strip.

the extracted specimen contains RSV lf antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip. If RSV viral antigens are not present,

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Device Description (cont.)

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®RSV Test	Binax NOW® RSV Test
Intended Use	The QuickVue® RSV test allowsfor the rapid, qualitative detectionof respiratory syncytial virus (RSV)directly from nasopharyngealswab, nasopharyngeal aspirateand/or nasal wash specimens.The test is intended for use as anaid in the rapid diagnosis of acuterespiratory syncytial viralinfections. Negative test resultsshould be confirmed by cellculture. The test is intended forprofessional and laboratory use.	The Binax NOW® RSV Test is arapid immunochromatographicassay for the qualitative detectionof respiratory syncytial virus (RSV)fusion protein antigen in nasalwash and nasopharyngeal swabspecimens from symptomaticpatients. This test is intended forin vitro diagnostic use to aide inthe diagnosis of RSV infections inneonatal and pediatric patientsunder the age of five. It isrecommended that negative testresults be confirmed by culture.
Specimen Types	Nasopharyngeal SwabNasopharyngeal Aspirate and/orNasal Wash	Nasopharyngeal SwabNasal Wash
Extract / Elute	Extraction reagent used forswab/aspirate/wash	Transport liquid used for swabWash – no dilution required
Read Result Time	15 Minutes	15 Minutes
Format	Lateral-flow immunoassayDipstick	Lateral-flowimmunochromatographicmembrane assayCardboard with book shapedhinge
Control Features	Procedural Control LineClearing of Background	Procedural Control LineClearing of Background
External Controls	Positive RSV swabRSV Negative swab coated withStreptococcuе C antigen	Positive RSV swabRSV Negative swab coated withStreptococcus A antigen

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Summary of Performance Data:

Numerous studies were undertaken to document the performance characteristics Nomerous stadios word andorants of the test to the predicate device. These studies included the following:

A multi-center field clinical study was conducted. Sensitivity, specificity 1. and overall accuracy were calculated using nasopharyngeal aspirates and nasopharyngeal swabs compared to viral culture.
A clinical performance study with frozen nasal washes demonstrated the 2. QuickVue® RSV gave excellent agreement with a predicate device presently marketed legally in the United States.
Physician's Office studies were conducted to demonstrate that physician 3. office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly.
Analytical studies demonstrated lot-to-lot consistency, inter- and intra-4. lot precision, that common drugs and biologicals did not interfere with the test's performance, and that variations in the test method did not impact the test's performance.
A transport media study to select suitable media for the transport of 5. clinical samples identified several transport media that performed optimally.

Conclusion:

These studies demonstrated the substantial equivalence of the QuickVue® RSV 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP = 8 2006

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

Re: K061008 Trade/Device Name: QuickVue® RSV Test Regulation Number: 21 CFR § 866.3480 Regulation Name: Respiratory syncytial virus serological reagents Regulatory Class: I Product Code: MCE Dated: August 17, 2006 Received: August 21, 2006

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 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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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 (240)276-0450. 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,

Sally, atton

Sally A. Hojvat, M.Sc., 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 known):

4061008

Device Name:

QuickVue® RSV test

Indications for Use:

Prescription Use_ X (Part 21 CFR 801 Subpart D)

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Solgath

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k)________________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 866.3480 Respiratory syncytial virus serological reagents.

(a)
Identification. Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.