The Directigen™ EZ RSV test is a rapid chromatographic immunoassay for the direct and qualitative detection of Respiratory Syncytial Virus (RSV) antigen in nasopharyngeal washes, nasopharyngeal aspirates, nasopharyngeal swabs and nasopharyngeal swab/washes from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of Respiratory Syncytial Virus (RSV) infections in neonatal and pediatric patients under the age of 20. It is recommended that negative test results be confirmed by cell culture.

Device Description

The Directigen EZ RSV antigen detection test is a chromatographic assay to detect RSV antigens extracted from various specimens of symptomatic patients. The speed and workflow of the Directigen EZ RSV test make it applicable as a "STAT" RSV antigen detection test, providing rapid, relevant information to assist with antiviral intervention and other clinical or support decisions.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BD Directigen™ EZ RSV assay:

This 510(k) submission (K101514) is for a modification to an already legally marketed device, the BD Directigen™ EZ RSV assay (K022133). The modification is specifically the change of controls from liquid to dry swabs. Therefore, the studies presented focus on demonstrating that these new dry controls perform equivalently and are as stable as the previously approved liquid controls, rather than a full efficacy study of the assay itself.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Dry swabs controls must be comparable in stability to current liquid controls	Data to date from accelerated stability studies: indicated 30 months at 2-30°C. Confirmatory real time stabilities: indicated 5 months at 2-30°C. (Real-time stability studies will continue.)
Dry swabs controls must perform in the assay comparable to the current liquid controls	Dry swabs perform comparably in the assay to the current liquid controls.

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

The document does not specify the exact sample sizes used for the stability and performance studies of the dry swab controls. It only states "Data to date from accelerated stability studies" and "Confirmatory real time stabilities" for stability, and "Dry swabs perform comparably in the assay" for performance.

Data Provenance: Not explicitly stated, but these are likely internal validation studies conducted by the manufacturer (Becton, Dickinson and Company). The document does not indicate country of origin for the data or if it's retrospective or prospective, though performance and stability studies are generally prospective.

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

Not applicable in the context of this submission. The ground truth here is the established performance of the previous liquid controls and the expectation that the new dry controls should match that performance. There is no mention of external experts being used for this comparison.

4. Adjudication Method for the Test Set

Not applicable. This submission concerns the performance of controls, not diagnostic interpretations requiring adjudication.

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. This device is a rapid chromatographic immunoassay, not an AI-powered diagnostic system, and it does not involve human readers interpreting results in a way that typically necessitates an MRMC study.

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

Not applicable. This is an in vitro diagnostic device, not an algorithm. The "standalone" performance here refers to the device's ability to accurately detect the RSV antigen using the new controls in laboratory settings, which is what the performance studies aimed to demonstrate.

7. The Type of Ground Truth Used

The ground truth used for these studies is the performance characteristics of the legally marketed predicate device's liquid controls. The goal was to establish that the new dry controls yield equivalent or better results (in terms of stability and assay performance) compared to the established liquid controls.

8. The Sample Size for the Training Set

Not applicable. This is an in vitro diagnostic assay with modified controls, not a machine learning algorithm requiring a "training set" in the conventional sense. The "training" for the device would have implicitly happened during its original development (K022133), but this document focuses on the validation of the control modification.

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

Not applicable, as there isn't a "training set" for an algorithm. For the original assay's development, the ground truth would have been established through a combination of clinical samples confirmed by a gold standard method (e.g., cell culture for RSV detection). However, this information is not part of this specific 510(k) submission which only addresses the control modification.

Summary

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K101514

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510(K) SUMMARY

SUBMITTED BY:	BECTON, DICKINSON AND COMPANY11085 NORTH TORREY PINES ROADSUITE 210LA JOLLA, CA 92037Tel: (858) 795 7890Fax: (858) 795 7885	JUL-9 2010
CONTACT NAME:	Gregory P. Payne, RAC, DirectorRegulatory Affairs
DATE PREPARED:	May 28, 2010
DEVICE TRADE NAME:	BD Directigen™ EZ RSV assay
DEVICE COMMON NAME:	Respiratory Syncytial virus serologicalreagents
DEVICE CLASSIFICATION:	21 CFR 866.3480
PREDICATE DEVICES :	BD Directigen™ EZ RSV assay (K022133)
INTENDED USE :

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DEVICE DESCRIPTION :

DEVICE COMPARISON:

The modified kit differs from the currently marketed BD Directigen™ EZ RSV kit in the following way:

The controls have been changed from liquid to dry swabs.

SUBSTANTIAL EQUIVALENCE:

The modified device BD Directigen™ EZ RSV is substantially equivalent to the current legally marketed device, BD Directigen™ EZ RSV assay.

Modifications are as follows:

Modification	Potential Impact of Modification
Change of control from Liquid to dry swab.	Dry controls are more stable than liquid controls. Useof dry control swabs allows for optimal inventorymanagement during viral outbreaksAdditionally, rare customer complaints regarding controlfailures have been attributed to improper processing(protocol not followed, processing agent not added toliquid control). This possibility is eliminated byconversion to dry swab controls.
	Dry swabs controls are also supplied by mostcompetitors.
	Dry swabs may not perform like liquid controls or be asstable. Stability and swab performance studies willdefine stability and performance characteristics of theswabs.

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Included in the Special 510(k) are the Hazard Analysis and the associated validations and verifications conducted to address individual hazards/risks identified for this modification. The Hazard Analysis did not identify any changes that raised new issues of safety and effectiveness. The parameters listed below were evaluated in studies performed according to appropriate Design Control procedures. The modified BD Directigen™ EZ RSV assay met all current product claims for performance.

Parameter	Result
Dry swabs controls must becomparable in stability to currentliquid controls	Data to date from accelerated stabilitystudies have indicated 30 months at 2-30C.Confirmatory real time stabilities haveindicated 5 months at 2-30C. Real timestabilities will continue.
Dry swabs controls must perform inthe assay comparable to thecurrent liquid controls	Dry swabs perform comparably in the assayto the current liquid controls.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Becton. Dickinson and Company BD Diagnostics Gregory P. Payne Director, Regulatory Affairs and Quality Systems 11085 North Torrey Pines Road, Suite 210 La Jolla, CA 92037

JUL 0 9 2010

Re: K101514

Trade/Device Name: BD Directigen™ EZ RSV Assay Regulation Number: 21 CFR 866.3480 Regulation Name: Respiratory syncytial virus serological reagents Regulatory Class: Class I Product Code: GQG Dated: May 28, 2010 Received: June 2, 2010

Dear Mr. Payne:

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 class II (Special Controls), 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); medical device reporting

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(reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.htm 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/cdrh/industry/support/index.html.

Sincerely yours.

Jals uAtaym

Sally A. Hoivat, 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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Snecial 510(k) Control Swat

Confidential

INDICATION FOR USE

510(K) Number (if known)

Device Name: BD Directigen™ EZ RSV assay

Indication for Use:

Prescription Use X 21 CFR 801 Subpart D) And/or

Over the Counter Use (21 CFR 801Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Uwe Schaf

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k 101514

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.