The QuickVue RSV test is a dipstick immunoassay which allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) antigen (viral fusion protein) directly from nasopharyngeal swab, nasopharyngeal aspirate, or nasal/nasopharyngeal wash specimens for symptomatic pediatric patients (eighteen years of age and younger). The test is intended for use as an aid in the diagnosis of acute respiratory syncytial viral infections. It is recommended that negative test results be confirmed by cell culture. Negative results do not preclude RSV infection and it is recommended that they not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

Device Description

Nasopharyngeal swabs. nasopharyngeal aspirate, and nasal/nasopharyngeal wash 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. 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

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

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Sensitivity	Not explicitly stated in the document.
Specificity	Not explicitly stated in the document.
Overall Accuracy	Not explicitly stated in the document.

Note: While sensitivity, specificity, and overall accuracy were calculated as part of the study, the specific numerical acceptance criteria (e.g., "Sensitivity must be >90%") and the actual calculated values are not presented in this summary document. The document only states that "A multi-center field clinical study was undertaken to document the performance characteristics of the test. Sensitivity, specificity and overall accuracy were calculated using nasal/nasopharyngeal wash specimens compared to viral culture."

Study Information

Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "A multi-center field clinical study" was conducted, and it involved "nasal/nasopharyngeal wash specimens." The country of origin of the data is not specified but implied to be within the US due to FDA submission. The study type is a clinical study, which typically implies prospective data collection, though this is not explicitly stated as "prospective" or "retrospective."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated.
Adjudication method for the test set: Not applicable based on the provided information, as ground truth was established by viral culture rather than expert consensus on device results.
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: Not applicable. This device is a dipstick immunoassay, not an AI-powered diagnostic requiring human-in-the-loop interpretation or MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the performance characteristics (sensitivity, specificity, accuracy) were calculated for the device itself as a standalone diagnostic, comparing its results to a ground truth (viral culture).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Viral culture. The summary states, "Sensitivity, specificity and overall accuracy were calculated using nasal/nasopharyngeal wash specimens compared to viral culture."
The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set in the conventional sense. The test relies on a lateral-flow immunoassay with pre-defined reagents.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary

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K070747

APR 2 3 2007

510(k) SUMMARY

Submitted By:

Quidel Corporation 10165 McKellar Court San Diego, California 92121 Telephone: 858-552-7910 858-646-8045 Fax:

Submission Contact: Jennifer Hankard

March 16, 2007 Date Prepared:

Device Trade Name: QuickVue® RSV test

Common Name: Respiratory Syncytial Virus (RSV) Test

QuickVue® RSV test (K061008) Predicate Device:

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

These tests are used to aid in the diagnosis of disease caused by respiratory syncytial viruses and provides epidemiological information on these diseases (21 CFR 866.3480). The Food classified and Drug Administration has serological test systems for the detection of respiratory syncytial virus as Class I.

Intended Use: The QuickVue RSV test is a dipstick immunoassay which allows for the rapid. qualitative detection of respiratory syncytial virus (RSV) antigen (viral fusion protein) directly from nasopharyngeal swab, nasopharyngeal aspirate, or nasal/nasopharyngeal wash specimens for symptomatic pediatric patients (eighteen years of age and younger). The test is intended for use as an aid in the diagnosis of acute respiratory syncytial viral infections. It is recommended that negative test results be confirmed by cell culture. Negative results do not preclude RSV infection and it is recommended that they not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory 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. Nearly half of all children become infected by their first year of life. It is also the major viral cause of nosocomial illness in children already hospitalized for other reasons. In the United States, RSV is estimated to be responsible for 73,400 to 126,300 hospitalizations annually for bronchiolitis and pneumonia alone among children younger than 1 year. In children hospitalized with RSV infection, it is believed to be the most common viral cause of death in children younger than 5 years, particularly in children younger than one year. Among children hospitalized with RSV infection, the mortality rate is estimated to be as low as 0.3% to 1.0% of hospitalized children and in the range of 2.5% to 4.0% for hospitalized children with underlying cardiac or pulmonary disease.

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 nasal/nasopharyngeal wash 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.

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.

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Device Comparison:

Features	QuickVue® RSV test(Proposed)	QuickVue® RSV test(K061008)
Intended Use	The QuickVue RSV test is a dipstickimmunoassay which allows for therapid, qualitative detection ofrespiratory syncytial virus (RSV)antigen (viral fusion protein) directlyfrom nasopharyngeal swab,nasopharyngeal aspirate, ornasal/nasopharyngeal washspecimens for symptomatic pediatricpatients (eighteen years of age andyounger). The test is intended foruse as an aid in the diagnosis ofacute respiratory syncytial viralinfections. It is recommended thatnegative test results be confirmed bycell culture. Negative results do notpreclude RSV infection and it isrecommended that they not be usedas the sole basis for treatment orother management decisions. Thetest is intended for professional andlaboratory use.	The QuickVue RSV test is a dipstickimmunoassay which allows for therapid, qualitative detection ofrespiratory syncytial virus (RSV)antigen (viral fusion protein) directlyfrom nasopharyngeal swab ornasopharyngeal aspirate specimensfor symptomatic pediatric patients(eighteen years of age and younger).The test is intended for use as an aidin the diagnosis of acute respiratorysyncytial viral infections. It isrecommended that negative testresults be confirmed by cell culture.Negative results do not precludeRSV infection and it is recommendedthat they not be used as the solebasis for treatment or othermanagement decisions. The test isintended for professional andlaboratory use.
Specimen Types	Nasopharyngeal swab,Nasopharyngeal aspirate, andNasal/nasopharyngeal wash	Nasopharyngeal swab andNasopharyngeal aspirate
Extract / Elute	Extraction reagent used forswab/aspirate/wash	Extraction reagent used forswab/aspirate
Read Result Time	15 Minutes	15 Minutes
Format	Lateral-flow immunoassay dipstick	Lateral-flow immunoassay dipstick
Control Features	Procedural Control LineClearing of background	Procedural Control LineClearing of background
External Controls	Positive RSV swabRSV negative swab coated withStreptococcus C antigen	Positive RSV swabRSV negative swab coated withStreptococcus C antigen

Summary of Performance Data:

A multi-center field clinical study was undertaken to document the performance characteristics of the test. Sensitivity, specificity and overall accuracy were calculated using nasal/nasopharyngeal wash specimens compared to viral culture.

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Conclusion:

This study demonstrated the substantial equivalence of the QuickVue® RSV test with the addition of the nasal/nasopharyngeal wash specimen type to existing products already marketed. This study further demonstrated the suitability of the product for professional and laboratory use. Clinical 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/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and three bars below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Jennifer Hankard Regulatory Affairs Manager Quidel Corporation 10165 McKellar Court San Diego, CA 92121

APR 2 3 2007

Re: K070747

Trade/Device Name: QuickVue® RSV Test Regulation Number: 21CFR 866.3480 Regulation Name: Respiratory syncytial virus serological reagents Regulatory Class: Class I Product Code: GOG Dated: March 16, 2007 Received: March 19, 2007

Dear Ms. Hankard:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 J 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, artm

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):

K 070747

Device Name:

QuickVue® RSV test

Indications for Use:

Prescription Use x (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
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Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k)	K070747

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.