The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) my microdilution methodology. The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 automatically fills, seals and places the card into the incubator/reader. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the VITEK® 2 Gram Positive Quinupristin/dalfopristin device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems)	Reported Device Performance
Acceptable performance as defined by the guidance document	96.6% overall Essential Agreement
Reproducibility demonstrated acceptable results	Acceptable results
Quality Control demonstrated acceptable results	Acceptable results

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

Sample Size for Test Set: Not explicitly stated as a numerical value for the total number of isolates. The document mentions an "external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains." This implies a varied collection but no specific count.
Data Provenance: The external evaluation suggests that the clinical isolates were likely from a real-world setting, potentially encompassing multiple locations given the term "external evaluation." However, the exact country of origin or whether it was retrospective or prospective is not specified. "Fresh clinical isolates" imply prospective collection, while "stock clinical isolates" could be either.

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

This information is not provided in the document. The ground truth method (NCCLS microbroth dilution reference method) is stated, but not the process of establishing that ground truth or the involvement of human experts for this step.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The study focused on the VITEK 2 device's performance against a reference method (NCCLS microbroth dilution) in a standalone manner, not comparing human readers with and without AI assistance.

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

Yes, a standalone study was done. The entire evaluation described is of the VITEK® 2 system's performance (an automated device/algorithm) in determining antimicrobial susceptibility. The "Essential Agreement" and comparison to a reference method are metrics of the standalone device's accuracy.

7. The Type of Ground Truth Used

The ground truth used was the NCCLS microbroth dilution reference method. This is considered a gold standard laboratory method for determining minimum inhibitory concentrations (MICs) of antimicrobials.

8. The Sample Size for the Training Set

The document does not mention a training set or any details related to machine learning model development. This device appears to be an automated instrument based on established principles of microbiology (microdilution methodology) rather than a machine learning algorithm that requires a separate training phase.

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

As there is no mention of a training set, this information is not applicable.

Summary

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K032738

OCT 3 1 2003

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510(k) SUMMARY

VITEK® 2 Gram Positive Quinupristin/dalfopristin

A. Submitter Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Nancy WeaverStaff Regulatory Affairs Specialist
Phone Number:	(314) 731-8695
Fax Number:	(314) 731-8689
Date of Preparation:	September 2, 2003
Device Name:

B. Device Name:

Formal/Trade Name:	VITEK® 2 Gram Positive Quinupristin/dalfopristin (0.25 - 2.0 µg/ml)
Classification Name:	Fully Automated Short-Term Incubation Cycle AntimicrobialSusceptibility Device, 21 CFR 866.1645
Common Name:	VITEK 2 AST-GP Quinupristin/dalfopristin
Predicate Device:	VITEK® 2 Gram Positive Susceptibility Test for Norfloxacin(N50510/S110)

D. 510(k) Summary:

VITEK® 2 Gram Positive Quinupristin is designed for antimicrobial susceptibility testing of Enterococcus faecium (vancomycin-resistant), Staphylococcus aureus, Staphylococcus epidemidis and Streptococcus agalactiae. It is intended for use with the VITEK 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mog/ml. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) my microdilution methodology.

The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 automatically fills, seals and places the card into the incubator/reader. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

VITEK 2 Gram Positive Quinupristin demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution method, as defined in the Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; guidance for Industry and FDA. Issued February 5, 2003.

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The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive Quinupristin/ dalfopristin. An external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Positive Quinupristin by comparing its performance with the NCCLS microbroth dilution reference method. VITEK 2 Gram Positive Quinupristin demonstrated acceptable performance of 96.6% overall Essential Agreement when compared to the microbroth dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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OCT 3 1 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Nancy Weaver Staff Regulatory Affairs Specialist BioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320

Re: K032738

Trade/Device Name: VITEK 2® Gram Positive Quinupristin/dalfoprist.n (0.25-2.0 ug/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: September 2, 2003 Received: September 4, 2003

Dear Ms. Weaver:

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 Statement

510(k) Number (if known): KOB 2738

Device Name: VITEK® 2 Gram Positive Quinupristin (0.25 - 2.0 µg/ml)

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Luddie W. Poole
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032738

For Prescription Use Only

p. 10

Regulation Number and Section

§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.

(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”