VITEK® 2 Streptococcus Erythromycin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK 2 Streptococcus Erythromycin 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. Erythromycin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections Streptococcus pneumoniae Streptococcus pyogenes

Active in vitro but clinical significance unknown Viridans group Streptococci

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 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 spp. and clinically significant yeast.

Device Description

The VITEK 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK 2 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 spp. and clinically significant yeast.

The antimicrobial presented in VITEK 2 AST-ST Cards is in concentrations equivalent by efficacy to standard method concentrations in ug/mL. The VITEK® 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% 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 Compact has a manual filling and sealing operation. 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 antimicrobial contained on the card.

AI/ML Overview

Here's an analysis of the VITEK® 2 Streptococcus Erythromycin device based on the provided text, broken down by your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from FDA Guidance Document)	Reported Device Performance (VITEK® 2 Streptococcus Erythromycin)
Overall Essential Agreement with reference method	97.9%
Overall Category Agreement with reference method	96.7%
Reproducibility	Acceptable results
Quality Control	Acceptable results

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

Sample Size: Not explicitly stated as a single number. The document mentions "fresh and stock clinical isolates, as well as a set of challenge strains." Without specific numbers, it's impossible to provide an exact sample size for the test set.
Data Provenance: The study was an "external evaluation." The country of origin is not specified, nor is whether the data was retrospective or prospective. Given it involved "fresh and stock clinical isolates," it implies a mix of prospectively collected (fresh) and retrospectively stored (stock) data.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The ground truth was established using the "CLSI broth microdilution reference method," which is a laboratory standard rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or not specified. The ground truth was determined by a standardized laboratory method (CLSI broth microdilution), which does not typically involve adjudication by multiple human experts in the same way an imaging study might.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an automated antimicrobial susceptibility test system, not a diagnostic imaging or interpretive aid that typically involves human readers. The comparison was device vs. a reference laboratory method.
Effect Size: Not applicable as no MRMC study was performed.

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

Standalone Performance: Yes, the study evaluated the standalone performance of the VITEK® 2 system. The system automatically fills, seals, incubates, reads, and generates a report with MIC values and interpretive categories. The performance metrics (Essential Agreement and Category Agreement) directly reflect the algorithm's accuracy compared to the reference method.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth was established using a laboratory reference method: the "CLSI broth microdilution reference method" incubated at 24 hours.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not specified. The document describes the "Premarket Notification (510[k]) presents data in support of VITEK® 2 Streptococcus Erythromycin," implying the study data is for validation. Information on the training set used to develop the VITEK® 2 system's algorithms for Erythromycin is not provided in this summary.

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

How Ground Truth for Training Set Was Established: Not specified in the provided text.

Summary

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K 111976

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FEB 1 7 2012

510(k) SUMMARY

VITEK® 2 Streptococcus Erythromycin

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Jennifer Chia-Hsuan LinRegulatory Affairs Specialist
Phone Number:	314-731-8639
Fax Number:	314-731-8689
Date of Preparation:	July 1, 2011
Device Name:
Formal/Trade Name:	VITEK® 2 Streptococcus Erythromycin
Classification Name:	21 CFR 866.1645Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility SystemProduct Code LON
Common Name:	VITEK® 2 AST-ST Erythromycin
Predicate Device:	VITEK® 2 Gram Positive Amoxicillin for Streptococcuspneumoniae (K063597)

D. 510(k) Summary:

VITEK® 2 Streptococcus Enthromycin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK 2 Streptococcus Erythromycin 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. Erythromycin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections Streptococcus pneumoniae Streptococcus pyogenes

Active in vitro but clinical significance unknown Viridans group Streptococci

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VITEK® 2 Streptococcus Erythromycin demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA 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 Streptococcus Erythromycin. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 Streptococcus Erythromycin by comparing its performance with the CLSI broth microdilution reference method incubated at 24 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 Streptococcus Erythromycin demonstrated acceptable performance of 97.9% overall Essential Agreement and 96.7% overall Category Agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results using both the VITEK 2 Compact instrument svstems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

bioMérieux, Inc. c/o Jennifer Chia-Hsuan Lin Regulatory Affairs Specialist 595 Anglum Road Hazelwood, MO 63042

FEB 1 7 2012

Re: K111976

Trade Name: VITEK®2 Streptococcus Erythromycin Regulation Number: 21 CFR §866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON Dated: January 25, 2012 Received: January 27, 2012

Dear Ms. Lin:

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 class II (Special Controls), it may be subject to such 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 Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); 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-

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Page 2 - Jennifer Chia-Hsuan Lin

This letter will allow you to begin marketing your device as described in your Section 1000. The letter 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 advice for your device on our labeling regulation (21 CFR Part 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety 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,

Uhe Self 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):__ k

Device Name: VITEK® 2 Streptococcus Erythromycin (≤0.125 - ≥8 µg/mL)

Indications For Use:

Active in vitro and in clinical infections Streptococcus pneumoniae Streptococcus pyogenes

Active in vitro but clinical significance unknown Viridans group Streptococci

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 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)

Eucldia. Poole

sion Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Sufety

510(k) K111976

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.”