VITEK® 2 Streptococcus Tetracycline is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK 2 Streptococcus Tetracycline 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. Tetracycline has an antimicrobial activity against the microorganisms listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections Streptococcus pneumoniae Streptococcus pyogenes 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 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 with 0.45% to 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. sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 36 hours for yeast). 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 acceptance criteria and study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Target Performance)	Reported Device Performance (VITEK® 2 Streptococcus Tetracycline)
Essential Agreement (EA) with CLSI broth microdilution reference method	96.8% Overall Essential Agreement
Category Agreement (CA) with CLSI broth microdilution reference method	97.1% Overall Category Agreement
Reproducibility	Acceptable results
Quality Control	Acceptable results

2. Sample Size and Data Provenance for the Test Set

Sample Size: The document states that the external evaluation was conducted with "fresh and stock clinical isolates, as well as a set of challenge strains." However, specific numerical sample sizes for these categories are not provided.
Data Provenance: The text does not explicitly state the country of origin for the data. It also doesn't explicitly state whether the clinical isolates were retrospective or prospective, though the mention of "fresh clinical isolates" implies prospective collection for at least some portion of the data.

3. Number of Experts and Qualifications for Establishing Ground Truth (Test Set)

The document states that performance was compared to the "CLSI broth microdilution reference method." The CLSI method itself is considered the gold standard and thus represents the ground truth.
Number of Experts: This method does not typically involve "experts" in the sense of human readers adjudicating results. Instead, it relies on standardized laboratory procedures and measurements.
Qualifications of Experts: Not applicable, as the ground truth is established by a standardized reference method rather than human expert consensus.

4. Adjudication Method for the Test Set

None in the traditional sense. The ground truth is the CLSI broth microdilution reference method. Adjudication between human experts is not relevant here as the comparison is between the automated VITEK® 2 system and a standardized laboratory method. The "agreement" metrics (essential and category) are direct comparisons of the VITEK® 2's results to the CLSI results.

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

No, an MRMC comparative effectiveness study was not done. This study evaluates the performance of an automated susceptibility test system against a reference laboratory method, not the improvement of human readers with AI assistance.

6. Standalone Performance

Yes, a standalone study was done. The entire study described focuses on the performance of the VITEK® 2 Streptococcus Tetracycline device (the algorithm/system itself) in determining antimicrobial susceptibility, without human intervention in interpreting the results once the system has processed the sample. The results (Essential Agreement and Category Agreement) are direct measures of the algorithm's performance against the reference method.

7. Type of Ground Truth Used

CLSI broth microdilution reference method. This is a recognized laboratory standard method for determining minimum inhibitory concentration (MIC) and interpretive categories for antimicrobial susceptibility.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. It only describes the external evaluation for performance confirmation.

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

The document does not explicitly state how the ground truth for the training set was established. Given that the VITEK® 2 is an established platform, it's highly probable that training involved extensive data generation using similar gold standard reference methods (like CLSI broth microdilution) to develop and calibrate the interpretive algorithms. However, this information is not present in the provided text.

Summary

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FEB 2 8 2012

510(k) SUMMARY

VITEK® 2 Streptococcus Tetracycline

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Jolyn TenlladoDirector, Regulatory Affairs
Phone Number:	314-731-8386
Fax Number:	314-731-8689
Date of Preparation:	July 1st, 2011

B. Device Name:

Formal/Trade Name:	VITEK® 2 Streptococcus Tetracycline
Classification Name:	21 CFR 866.1645Antimicrobial Susceptibility TestProduct Code LON
Common Name:	VITEK® 2 AST-ST Tetracycline
Predicate Device:	VITEK® 2 AST-GP Amoxicillin for S. pneumoniae (K063597)

D. 510(k) Summary:

VITEK® 2 Streptococcus Tetracycline is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 Streptococcus Tetracycline 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. Tetracvcline has an antimicrobial activity aqainst the microorganisms listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections Streptococcus pneumoniae Streptococcus pyogenes Viridans group streptococci

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 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 Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/mL. The VITEK® 2 AST cards are essentially miniaturized

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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 with 0.45% to 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. sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 36 hours for yeast). 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.

VITEK® 2 Streptococcus Tetracycline 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 Tetracycline. 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 Streptococus Tetracycline by comparing its performance with the CLSI broth microditution reference method. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® Streptococcus Tetracycline demonstrated acceptable performance of 96.8% overall essential agreement and 97.1% overall category agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results using both the VITEK® 2 and VITEK® 2 Compact instrument systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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10903 New Hampshire Avenue Silver Spring, MD 20993

bioMérieux, Inc. c/o Jolyn Tenllado Director, Regulatory Affairs 595 Anglum Road Hazelwood. MO 63042

FEB 2 8 2012

Re: K111893

Trade Name: VITEK®2 Streptococcus Tetracycline Regulation Number: 21 CFR §866.1645 Antimicrobial Susceptibility Test Regulation Name: Class II Regulatory Class: Product Code: LON Dated: February 10, 2012 Received: February 13, 2012

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 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 (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 1000-1050. This letter will allow you to begin marketing your device as described in your Section

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Page 2 - Jolyn Tenllado

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 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,

Luedali tur Poole
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): KJLL833

Device Name; VITEK® 2 Streptococcus Tetracycline (≤ 0.25 - ≥ 16 ug/mL)

Indications For Use:

Active in vitro and in clinical infections Streptococcus pneumoniae Streptococcus pyogenes Viridans group streptococci

× 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)

Freddie W. Poole

Vision Sign-Off

Office of In Vitro Diagnostic Device . Evaluation and Safety

510(k) K111893

Page 1 of 1

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.”