VITEK® 2 AST-GP Clindamycin is designed for antimicrobial susceptibility testing of Staphylococcus aureus and Staphylococcus epidermidis. VITEK 2 AST-GP Clindamycin is a quantitative test intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Clindamycin has been shown to be active against most strains of the microorganism listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections Staphylococcus aureus (methicillin-susceptible strains) and Staphylococcus epidermidis (methicillin-susceptible strains)

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK 2 Compact Systems 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.

Device Description

The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

The bacterial isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time. 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

The VITEK® 2 AST - Gram Positive Clindamycin device is designed for antimicrobial susceptibility testing of Staphylococcus aureus and Staphylococcus epidermidis. The study aimed to demonstrate its substantial equivalence to the CLSI broth microdilution reference method.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (from Class II Special Controls Guidance)	Reported Device Performance
Overall Category Agreement	Not explicitly stated in the provided text but implied by "acceptable performance" and comparison to CLSI guidance. Typically, for AST devices, this is >= 90-95% for essential agreement and category agreement.	99.4% Overall Category Agreement
Reproducibility	Acceptable results (implied by CLSI guidance)	Acceptable results
Quality Control	Acceptable results (implied by CLSI guidance)	Acceptable results

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

The document mentions an "external evaluation" conducted with:

Fresh and stock clinical isolates: The exact number is not specified.
Stock challenge strains: The exact number is not specified.

The provenance of the data (e.g., country of origin) is not explicitly stated, but it is an "external evaluation," suggesting it was not solely internal data from bioMérieux. It also doesn't explicitly state if the data was retrospective or prospective, though clinical isolates generally imply prospective collection or recent isolates.

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

This information is not provided in the given text. The ground truth method is the CLSI broth microdilution reference method, which is a standardized laboratory procedure, not typically established by human experts in the same way imaging or pathology ground truth might be.

4. Adjudication method for the test set

This information is not applicable and therefore not provided. The ground truth is established by a standardized laboratory reference method (CLSI broth microdilution), not through expert consensus requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices where human reading is involved, such as medical imaging. For an antimicrobial susceptibility test system, the comparison is between the automated device and a standardized reference method.

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

Yes, the study describes a standalone performance evaluation. The VITEK® 2 AST system, in both VITEK 2 and VITEK 2 Compact platforms, generates results (MIC value and interpretive category) autonomously. Its performance was compared directly against the CLSI broth microdilution reference method without human intervention in the result determination phase of the device itself.

7. The type of ground truth used

The type of ground truth used was the CLSI broth microdilution reference method. This is a well-established, standardized laboratory methodology for determining antimicrobial susceptibility, considered the gold standard for MIC determination.

8. The sample size for the training set

The sample size for the training set is not specified. The document describes an "external evaluation" which sounds more like a validation or test set rather than a training set. For an AST system, the device's algorithms or measurement principles are developed based on understanding microbial growth kinetics and established breakpoints, rather than explicitly "training" on a large dataset of results in the way machine learning algorithms are. The provided text focuses on the performance comparison of the final device.

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

As mentioned above, specific information about a "training set" and its ground truth establishment is not provided in the context of typical machine learning training. The VITEK® 2 system's underlying methodology likely relies on established microbiological principles and standardized breakpoints. If internal development involved optimization, the ground truth would similarly be established by reference methods like CLSI broth microdilution for those internal studies.

Summary

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KI22547

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OCT 1 5 2012

510(k) SUMMARY

VITEK® 2 AST- Gram Positive Clindamycin

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	100 Rodolphe StreetDurham, NC 27712

Contact Person:

Phone Number:

Fax Number:

Date of Preparation:

tham, NC 27712

Elizabeth (Betty) Landon Staff Regulatory Affairs Specialist

VITEK® 2 AST - Gram Positive Clindamycin

VITEK® 2 Gram Positive Linezolid (K032766)

919-620-2329

919-620-2548

Auqust 20, 2012

21 CFR 866.1645

Product Code LON

Antimicrobial Susceptibility Test

VITEK® 2 AST - GP Clindamycin

B. Device Name:

· Formal/Trade Name:

Classification Name:

Common Name:

C. Predicate Device:

D. 510(k) Summary:

VITEK 2 AST - Gram Positive Clindamycin is designed for an antimicrobial susceptibility testing of Staphylococcus aureus and Staphylococcus epidermidis. It is intended for use with the VITEK 2 and VITEK 2 Compact Systems 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 mcq/ml. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

VITEK 2 AST - Gram Positive Clindamycin for Staphylococcus aureus and Staphylococcus epidemidis demonstrated substantially equivalent performance with the CLSI broth microdilution reference method, as defined in the Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, issued August 28, 2009.

The Premarket Notification (510(k)) presents data in support of VITEK 2 AST - Gram Positive Clindamycin for Staphylococcus aureus and Staphylococcus epidermidis. An external evaluation was

bioMérieux, Inc. 100 Rodolphe Street, Durham, Allyge Zag & Tridge Phone: 919 620 2000 http://www.biomerieux-usa.com

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conducted with fresh and stock clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK AST - Gram Positive Clindamycin for Staphylococcus aureus and Staphylococcus epidermidis by comparing its performance with the CLSI broth microdilution reference method. The data is representative of performance on both the VITEK 2 and VITEK 2 Compact instrument platforms, as evidenced in the AST equivalency study presented in the VITEK 2 Compact 510(k), K050002. VITEK 2 AST - Gram Positive Clindamycin for Staphylococcus aureus and Staphylococcus epidermidis demonstrated acceptable performance of 99.4% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

October 15, 2012

CT 15 2012

bioMérieux, Inc. c/o Elizabeth Landon Staff Regulatory Affairs Specialist 595 Anglum Road Hazelwood, MO 63042

Re: K122547

Trade/Device Name: VITEK®2 AST- Gram Positive Clindamycin (≤ 0.12-≥4 µg/mL) Regulation Number: 21 CFR 866.1645 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: LON Dated: August 20, 2012 Received: August 21, 2012

Dear Landon:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Elizabeth Landon

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.

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 Diagnostics and Radiological Health 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,

Uwe Scherf for

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: VITEK® 2 AST - Gram Positive Clindamycin ( < 0.12 - ≥ 4 µg/mL )

Indications For Use:

Active in vitro and in clinical infections Staphylococcus aureus (methicillin-susceptible strains) and Staphylococcus epidermidis (methicillin-susceptible strains)

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)

signature

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