VITEK® Gram Positive Daptomycin is designed for antimicrobial susceptibility testing of Enterococcus faecalis, Staphylococcus aureus, Streptococcus agalactiae, Staphylococcus epidermidis and Stapylococcus haemolyticus. VITEK Gram Positive Daptomycin is a qualitative test. It is intended for use with the VITEK System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

The VITEK® Gram Positive 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 clinicant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

Device Description

VITEK® Gram Positive Daptomcyin is designed for antimicrobial susceptibility testing of Enterococcus faecalis, Staphyloccocus aureus, Steptococcus agalactiae, Staphylococcus epidermidis and Staphylococcous haemolyticus. It is intended for use with the VITEK® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK GPS Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK GPS Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

After the card is inoculated with a standardized organism suspension, it is placed in the Reader/Incubator of the VITEK System. Organism growth inside the card is optically monitored throughout the 6-15 hour incubation cycle. MIC results are automatically calculated once a predetermined growth threshold is reached, and a report is generated that contains the MIC result and the interpretive category result.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the VITEK® Gram Positive Daptomycin, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to the NCCLS reference agar dilution method	VITEK Gram Positive Ertapenem (Note: text error, should be Daptomycin) demonstrated substantially equivalent performance
Acceptable overall Category Agreement	99.5% overall Category Agreement when compared to the broth microdilution reference method
Acceptable Reproducibility	Demonstrated acceptable results
Acceptable Quality Control	Demonstrated acceptable results

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

Sample Size: Explicitly stated as "fresh and stock clinical isolates and stock challenge strains." The exact number of isolates is not provided in the summary, but it implies a diverse set of samples.
Data Provenance: The isolates included "fresh and stock clinical isolates" (implying retrospective clinical samples, potentially from various geographic regions where bioMérieux operates, though not specified) and "stock challenge strains" (likely well-characterized laboratory strains). The study was an "external evaluation," suggesting it was conducted at sites other than just the manufacturer's lab.

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

This information is not provided in the given text. The ground truth method is specified, but not the number or qualifications of experts involved in the reference method.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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 section is not applicable to this device. The VITEK® Gram Positive Daptomycin is an automated antimicrobial susceptibility testing system, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. It directly measures Minimum Inhibitory Concentration (MIC) and interpretive categories.

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

Yes, this study represents a standalone performance evaluation of the VITEK® device. The device itself performs the testing and generates the results automatically without human intervention for interpretation beyond initial setup and reading the final report.

7. The Type of Ground Truth Used

The ground truth used was the CLSI (formerly NCCLS) broth microdilution reference method.

8. The Sample Size for the Training Set

This information is not provided in the given text, as the summary focuses on the external validation study rather than the development or training of the device.

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

This information is not provided in the given text.

Summary

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NOV - 7 2005

BIOMÉRIEUX

K052656

510(k) SUMMARY

VITEK® Gram Positive Daptomycin

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:	September 23, 2005
B. Device Name:
Formal/Trade Name:	VITEK® Gram Positive Daptomycin (≤0.5-≥16µg/ml)
Classification Name:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device,21 CFR 866.1645
Common Name:	VITEK GPS Daptomycin
C. Predicate Device:	VITEK Gram Positive Susceptibility (GPS) Card forLinezolid (K022045)

D. 510(k) Summary:

bioMérieux, Inc. 595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/638-4´¯¯ http://www.biomerieux-usa.com

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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 Positive 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 Positive Daptomycin. 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 Gram Positive Dapytomycin by companing its performance with the CLSI (formerly NCCLS) broth microdilution reference method. VITEK Gram Positive Daptomycin demonstrated acceptable performance of 99.5% overall Category Agreement when compared to the broth microdilution reference method. Reproducibility and Quality Control demonstrated acceptable results.

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Food and Grug Administration 2098 Gaither Road Rockville MD 20850

NOV - 7 2005

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

Re: K052656

Trade/Device Name: VITEK® Gram Positive Daptomycin (≤0.5 - ≥16 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: September 23, 2005 Received: September 26, 2005

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 (240)276-0484. 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/industry/support/index.html

Sincerely yours,

Sally a. For

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): K05 a 656

Device Name: VITEK® Gram Positive Daptomycin (<0.5 - ≥16 µg/ml)

Indications For Use:

Prescription Use X (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)

Luddie Poole

Division Sign-Off

Page 1 of 1

Office of In Vitro Diagnostic Device Evaluation and Sulery

510(k)_ K 05 2656 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.”