VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN by BIOMERIEUX, INC.

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, Staphylooocus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae. VITER® Gram Negative Moxifloxacin is designed for antimicrobial susceptibility testing of Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, and Proteus mirabilis. VITEK Gram Negative Moxifloxacin 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

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AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for the VITEK® Gram Negative Moxifloxacin antimicrobial susceptibility testing device. It does not contain a detailed study report with specific acceptance criteria and performance data in the structured format requested.

Therefore, most of the information requested in your prompt cannot be extracted directly from this document. The document primarily confirms that the device is substantially equivalent to a legally marketed predicate device.

However, I can extract the following limited information:

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

This information is not present in the provided document. The letter only states that the device is "substantially equivalent" but does not detail the specific performance metrics or acceptance criteria used to make that determination, nor does it present the device's reported performance against such criteria.

2. Sample size used for the test set and the data provenance:

This information is not present in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not present in the provided document.

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

This information is not present in the provided document.

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:

This information is not present in the provided document. This device is an automated antimicrobial susceptibility testing system, not an AI-assisted diagnostic imaging tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable.

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

The device described is an "automated quantitative or qualitative susceptibility testing" system, implying it performs in a standalone manner (without human-in-the-loop performance for the actual susceptibility reading/interpretation). However, the details of the study proving this standalone performance are not provided in this document.

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

This information is not present in the provided document. For antimicrobial susceptibility testing, the ground truth would typically be established by a reference method, often a manual broth microdilution or agar dilution method according to CLSI (Clinical and Laboratory Standards Institute) guidelines.

8. The sample size for the training set:

This information is not present in the provided document.

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

This information is not present in the provided document.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 4 2005

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

Re: K043237

Trade/Device Name: VITEK® Gram Negative Moxifloxacin (concentrations of 2, 4, 8 µg/ml with calling range of ≤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 18, 2004 Received: November 22, 2004

Dear Ms. Tenllado:

This letter corrects our substantially equivalent letter of December 23, 2004, regarding the concentrations for the VITEK® Gram Negative Moxifloxacin (2 – 8 µg/ml) which was changed VITEK® Gram Negative intended use of the closed of 2, 4, 8 ug/ml with calling range of ≤0.5 - ≥8 ug/ml) to better reflect the intended use of the device.

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 provisions of the Anto 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 provisions of the Actuality, 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 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 10gally marketed predicate device results in a classification for your device and thus, persons 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)276-0484. Also, please one 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 thom of (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sally, a Harry

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): K043237

Device Name: VITEK® Gram Negative Moxifloxacin (concentrations of 2,4,8 µg/ml with calling range of ≤ 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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K043237 the page number is 10

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.”