The VITEK® Gram Negative Susceptibility Test is intended to be used with the VITEK® System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae. VITEK® Gram Negative Ertapenem is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca (excluding ESBL producing strains), Morganella morganii, Proteus mirabilis, Proteus vulgaris and Serratia marcescens. VITEK Gram Negative Ertapenem is for qualitative testing only. It is intended for use with the VITEK System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

Device Description

VITEK® Gram Negative Ertapenem is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca (excluding ESBL producing strains), Morganella morganii, Proteus mirabilis, Proteus vulgaris and Serratia marcescens. It is intended for use with the VITEK® System as a laboratory and in the determination of in vitro susceptibility to antimicrobial agents. The antimicry ial presented in VITEK GNS Cards is in concentrations equivalent by efficacy to atandard method concentrations in mcg/ml. The VITEK GNS Cards are essentially miniturized versions of the doubling dilution technique for determining the minimum in hilitory concentration (MIC) microdilution methodology.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the VITEK® Gram Negative Ertapenem device:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems)	Reported Device Performance (VITEK® Gram Negative Ertapenem)
Not explicitly stated in the provided text, but implied to be high agreement with NCCLS reference method	98.7% overall Category Agreement with NCCLS agar dilution reference method

Explanation of Acceptance Criteria (Inferred):
The document states that the device "demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems." While the specific numerical acceptance criteria (e.g., minimum percentage for Category Agreement, Essential Agreement) are not explicitly listed in the provided text, the phrase "substantially equivalent" and the reference to FDA guidance imply that the device needed to meet established performance standards for AST systems, which typically include high percentages for categories like "Category Agreement" and "Essential Agreement" when compared to a gold standard. The reported 98.7% Category Agreement indicates that the device met these implicit high standards.

2. Sample Size and Data Provenance for the Test Set

Sample Size for Test Set: An "external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains." The exact number of isolates used is not specified in the provided text.
Data Provenance: The text does not explicitly state the country of origin. The use of "fresh and stock clinical isolates" suggests real-world clinical samples, and "stock challenge strains" are typically well-characterized, standardized strains used for rigorous testing. The application is submitted by bioMérieux, Inc. in Hazelwood, MO, USA, and reviewed by the FDA, suggesting the study was likely conducted with data relevant to the US regulatory context.
Retrospective or Prospective: Not explicitly stated, however, "fresh clinical isolates" usually imply a prospective collection once the study began, while "stock clinical isolates" and "stock challenge strains" could be either, but are often used in a retrospective manner from existing collections.

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

Number of Experts: Not applicable/not specified.
Qualifications of Experts: Not applicable.

Explanation: The ground truth for this device is based on a laboratory reference method (NCCLS agar dilution method), not expert human interpretation. Therefore, experts are not used to establish the ground truth in the context of this study.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The "ground truth" is a laboratory reference method (NCCLS agar dilution method), so there is no need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No.
Effect size of human readers with vs. without AI assistance: Not applicable.

Explanation: This device is a fully automated antimicrobial susceptibility testing system, without direct human-in-the-loop diagnostic interpretation in the traditional sense. The comparison is between the automated system and a reference laboratory method, not between human readers with and without AI assistance for interpretation.

6. Standalone (Algorithm Only) Performance Study

Was a standalone study done? Yes. The study evaluates the performance of the VITEK® Gram Negative Ertapenem system "when compared with the NCCLS reference agar dilution method." This is a direct comparison of the device's output (algorithm only) against a gold standard, without human intervention in the interpretation process of the device's results.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth used is the NCCLS reference agar dilution method. This is a laboratory-based, objective, and standardized methodology for determining minimum inhibitory concentrations (MICs) of antimicrobials.

8. Sample Size for the Training Set

Sample Size for Training Set: The provided text does not specify the sample size for the training set. It focuses on the external evaluation (test set).

9. How Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: The text does not specify how the ground truth for any potential training set was established. However, given the nature of the device and the reference method used for the test set, it is highly probable that if a training set was used (which is standard for automated systems), its ground truth would also have been established using similar NCCLS reference methods or other standardized laboratory techniques.

Summary

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K043230

DEC 3 0 2004

Image /page/0/Picture/2 description: The image shows the logo for bioMérieux. The logo consists of a stylized globe with one half black and the other half white with horizontal lines. Below the globe is the company name, "BIOMÉRIEUX" in a simple sans-serif font.

510(k) SUMMARY

VITEK® Gram Negative Ertapenem

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Jolyn TenlladoRegulatory Affairs Specialist
Phone Number:	314-731-8386
Fax Number:	314-731-8689
Date of Preparation:	November 17, 2004
B. Device Name:
Formal/Trade Name:	VITEK® Gram Negative Ertapenem (≤0.5 – ≥8$µg/ml$ )
Classification Name:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device,21 CFR 866.1645
Common Name:	VITEK GNS Ertapenem
C. Predicate Device:	VITEK Gram Negative Susceptibility (GNS) Cardfor Gatifloxacin (K032711)

D. 510(k) Summary:

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calculated once a predetermined growth threshold is reached, and a report is generated that contains the MIC result and the interpretive category result.

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

The Premarket Notification (510[k]) presents data in support of VITEK Gram Negative Ertapenem. An external evaluation was conducted with fresh and stock clinical isalates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK Gram Negative Ertapenem by comparing its performance with the NCCLS agar dilution reference method. VITEK Gram Negative Ertapenem demonstrated acceptable performance of 98.7% overall Category Agreement when compared to the agar dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 3 0 2004

Ms. Jolyn Tenllado Regulatory Affairs Specialist BioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320

Re: K043230

Trade/Device Name: VITEK® Gram Negative Ertapenem (≤0.5 ->>8 µg/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: November 17, 2004 Received: November 22, 2004

Dear Ms. Tenllado:

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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Saartys

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): K043230

Device Name: VITEK® Gram Negative Ertapenem (≤ 0.5 – ≥ 8 µg/ml)

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)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Vor, ass
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluanon and Safety

KO43230 510(k)_

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.”