The Sofia RSV FIA employs immunofluorescence for detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients. This qualitative test is intended for use as an aid in the rapid diagnosis of acute RSV infections in pediatric patients less than 19 years of age. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative result is presumptive, and it is recommended these results be confirmed by virus culture or an FDA-cleared RSV molecular assay.

Device Description

The Sofia RSV FIA test employs immunofluorescence technology that is used with the Sofia Analyzer for the rapid detection of RSV antigens. The Sofia RSV FIA test involves the disruption of RSV viral antigens. The patient specimen is placed in the Reagent Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. After disruption, the specimen is dispensed into the Cassette sample well. From the sample well. the specimen migrates through a test strip containing various unique chemical environments. If RSV viral antigens are present, they will be trapped in a specific location.

Note: Depending upon the user's choice, the cassette is either placed inside of the Sofia Analyzer for automatically timed development (Walk Away Mode) or placed on the counter or bench top for a manually timed development and then placed into the Sofia Analyzer to be scanned (Read Now Mode).

The Sofia Analyzer will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. The Sofia Analyzer will display the test results (Positive, Negative, or Invalid) on the screen. The results can also be automatically printed on an integrated printer if this option is selected.

AI/ML Overview

The provided text describes the 510(k) summary for the Sofia® RSV FIA device, but it does not contain the specific acceptance criteria or the detailed results of the multi-center field clinical study that would allow for a complete table of acceptance criteria and reported device performance. The summary mentions that "Sensitivity and specificity were calculated" but does not provide the actual values or the criteria they were measured against.

Therefore, I cannot fulfill Request 1 directly from the provided text. I will answer the other requests based on the available information.

Here's a breakdown of the information that can be extracted and a note on what is missing:

1. A table of acceptance criteria and the reported device performance

MISSING: The document states that "Sensitivity and specificity were calculated" in the multi-center field clinical study, but it does not report the actual sensitivity and specificity values, nor does it specify any pre-defined acceptance criteria that these values were compared against. Without these numbers, a table cannot be created.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated in terms of a specific number of patients or specimens for the multi-center field clinical study. It only mentions that "nasopharyngeal swab and nasopharyngeal aspirate/wash specimens, both fresh and after storage in transport media" were used.
Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: The study is described as a "multi-center field clinical study," which generally implies a prospective collection of data in a real-world clinical setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

MISSING: The document does not specify the number of experts used or their qualifications for establishing the ground truth for the clinical study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

MISSING: The document does not describe any adjudication method used for the test set.

5. 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/NOT PERFORMED: The Sofia RSV FIA is an instrumented immunofluorescence assay, not an AI-based diagnostic image analysis device or a system requiring human interpretation with or without AI assistance in the way an MRMC study would typically evaluate. The Sofia Analyzer processes results using "method-specific algorithms" and displays "Positive, Negative, or Invalid" results. The study described focuses on the device's analytical and clinical performance against a predicate device, not on human reader performance.

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

YES (Implicitly): The device functions as a standalone diagnostic. The Sofia Analyzer "scans the test strip and measures the fluorescent signal by processing the results using method-specific algorithms" to display "Positive, Negative, or Invalid" results. This is an algorithmic determination without direct human interpretation of the underlying signal, fitting the definition of standalone performance. The clinical study evaluated the performance of this system (device + analyzer algorithm) against a reference standard.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The intended use statement specifies that "Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative result is presumptive, and it is recommended these results be confirmed by virus culture or an FDA-cleared RSV molecular assay."

Based on this, it is highly probable that the ground truth for the clinical study was established by either virus culture or an FDA-cleared RSV molecular assay as a reference method. The document implicitly supports this by recommending these methods for confirmation of negative results.

8. The sample size for the training set

NOT APPLICABLE/NOT PROVIDED: The document does not mention a "training set" in the context of machine learning. The device is an immunofluorescence assay with an analyzer that processes results using "method-specific algorithms." These algorithms are likely pre-programmed and validated, rather than being "trained" on a large dataset in the sense of deep learning models. The studies described are for analytical validation and clinical performance evaluation.

9. How the ground truth for the training set was established

NOT APPLICABLE/NOT PROVIDED: As no "training set" for a machine learning algorithm is discussed, this information is not applicable.

Summary

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K130398

510(k) SUMMARY

Submitted By:	Quidel Corporation10165 McKellar CourtSan Diego, California 92121Telephone: 858-552-7908Fax: 858-646-8045
Submission Contact:	John D. Tamerius, Ph.D.	AUG 1 3 2013
Date Prepared:	February 15, 2013
Device Trade Name:	Sofia® RSV FIA
Common Name:	Respiratory Syncytial Virus (RSV) Test
Predicate Device:	BD Veritor™ System for Rapid Detection of RSV,K121633
Device Classification/Name:	21 CFR 866.3480 / Respiratory syncytial virusserological reagents
	These tests are used to aid in the diagnosis of diseasecaused by respiratory syncytial viruses and provideepidemiological information on these diseases (21CFR 866.3480). The Food and Drug Administrationhas classified serological test systems for thedetection of respiratory syncytial virus as Class I.
Intended Use:	The Sofia RSV FIA employs immunofluorescencefor detection of respiratory syncytial virus (RSV)nucleoprotein antigen in nasopharyngeal swab andnasopharyngeal aspirate/wash specimens takendirectly from symptomatic patients. This qualitativetest is intended for use as an aid in the rapid diagnosisof acute RSV infections in pediatric patients less than19 years of age. Negative results do not precludeRSV infection and should not be used as the solebasis for treatment or for other managementdecisions. A negative result is presumptive, and it isrecommended these results be confirmed by virusculture or an FDA-cleared RSV molecular assay.

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Physiologic Basis of the Test: RSV is a causative agent of highly contagious, acute. viral infection of the respiratory tract in pediatric and elderly populations. Respiratory syncytial virus is a single-stranded RNA virus. Nearly half of all children become infected by RSV in 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% and in the range of 2.5% to 4.0% for children with underlying cardiac or pulmonary disease.

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Device Description:

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Device Comparison:

Item	Proposed Device	Predicate Device
Features	Sofia RSV FIA	BD Veritor™ System for RapidDetection of RSV, K121633
Intended Use	The Sofia RSV FIA employsimmunofluorescence for detectionof respiratory syncytial virus(RSV) nucleoprotein antigen innasopharyngeal swab andnasopharyngeal aspirate/washspecimens taken directly fromsymptomatic patients. Thisqualitative test is intended for useas an aid in the rapid diagnosis ofacute RSV infections in pediatricpatients less than 19 years of age.Negative results do not precludeRSV infection and should not beused as the sole basis for treatmentor for other management decisions.A negative result is presumptive,and it is recommended these resultsbe confirmed by virus culture or anFDA-cleared RSV molecular assay.	The BD Veritor System for RapidDetection of Respiratory SyncytialVirus (RSV) is a chromatographicimmunoassay with an instrumentedread for the direct and qualitativedetection of RSV fusion protein fromnasopharyngeal washes/aspirates andnasopharyngeal swabs in transportmedia samples from patients suspectedof having a viral respiratory infection.This test is intended for in vitrodiagnostic use to aid in the diagnosis ofRSV infections in infants and pediatricpatients under the age of 20 years.Negative results do not preclude RSVinfection and should not be used as thesole basis for treatment or for othermanagement decisions. A negative testis presumptive. It is recommended thatnegative test results be confirmed byviral cell culture or an alternativemethod, such as a FDA-clearedmolecular assay. The test is intendedfor professional and laboratory use. Itis to be used in conjunction with theBD Veritor System Reader.
Read Results	Read results on instrument screenor print with optional printer	Read results on instrument screen
Instrument	Sofia Analyzer	BD Veritor
Calibrator	Yes; a Calibration Cassette and QCCard are provided	No calibrator; a verification device isprovided to monitor device function
SpecimenTypes	Nasopharyngeal swab andnasopharyngeal aspirate/washspecimens; all specimens can betested fresh or after transport inmedia	Nasopharyngeal swab in transportmedia and nasopharyngealaspirate/wash specimens
Read ResultTime	15 Minutes	Approximately 10 Minutes
Item	Proposed Device	Predicate Device
Features	Sofia RSV FIA	BD Veritor™ System for RapidDetection of RSV, K121633
ExternalControls	RSV positive swabRSV negative swab	RSV positive swabRSV negative swab

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Summary of Performance Data:

Numerous studies were undertaken to document the performance characteristics and the substantial equivalence of the test to the predicate device. These studies included the following:

1. A multi-center field clinical study was undertaken to document the performance characteristics of the test. Sensitivity and specificity were calculated using nasopharyngeal swab and nasopharyngeal aspirate/wash specimens, both fresh and after storage in transport media.
1. A reproducibility study was performed to demonstrate intra- and inter-operator reproducibility and intra- and inter-laboratory reproducibility with a panel of test samples at various RSV concentrations.
1. Analytical studies included Limit of Detection, analytical reactivity, cross reactivity, interfering substances, operating temperature, lab precision/repeatability, viral transport media, inter-analyzer variation assessment, calibration cycle, and various flex studies.

Conclusion:

These studies demonstrated the substantial equivalence of the Sofia RSV FIA for use with the Sofia Analyzer to the existing product already marketed, BD Veritor System for Rapid Detection of RSV, K121633. 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/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized eagle-like emblem. The emblem is composed of three curved lines that suggest the wings and body of a bird, symbolizing health and human services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 13, 2013

JOHN D. TAMERIUS SENIOR VICE PRESIDENT, CLINICAL AND REGULATORY AFFAIRS QUIDEL CORPORATION 10165MCKELLAR COURT SAN DIEGO CA 92121

Re: K130398

Trade/Device Name: Sofia® RSV FIA Regulation Number: 21 CFR 866.3480 Regulation Name: Respiratory syncytial virus serological reagents Regulatory Class: I Product Code: GQG Dated: June 28, 2013 Received: July 1. 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Dr. Tamerius

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.hum 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sally A. Hojvat -S

Sally Hojvat. Ph.D., M. Sc Director, Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K130398

Device Name: Sofia® RSV FIA

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Tamara V. Fēldblīgum -S 2013.08.13 11-2:24:23 -04'00'

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

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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.