VITEK 2 Streptococcus Tigecycline is designed for antimicrobial susceptibility testing of Streptococcus species and 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. VITEK® 2 Streptococcus Tigecycline is a qualitative test. Tigecycline 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 (penicillin-susceptible isolates) Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus) Streptococcus agalactiae Streptococcus pyogenes

The VITER 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 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 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 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

The medical device, VITEK® 2 AST-ST Tigecycline, a fully automated short-term incubation cycle antimicrobial susceptibility system, was evaluated for its performance.

1. Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Overall Category Agreement with CLSI broth microdilution reference method	99.8%
Reproducibility	Acceptable
Quality Control	Acceptable

2. Sample Size and Data Provenance:

The study encompassed fresh and stock clinical isolates, as well as a set of challenge strains. The specific sample size for fresh, stock, and challenge isolates is not explicitly detailed beyond "an external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains." The data provenance (country of origin) is not provided, and the study was retrospective as it compared the device performance to an established reference method.

3. Number and Qualifications of Experts:

This information is not provided in the document. The study evaluates the performance of an automated susceptibility testing system against a reference method, not against human expert interpretation requiring a ground truth established by experts.

4. Adjudication Method:

Adjudication methods like 2+1 or 3+1 are not applicable here. The study compares the results of the VITEK® 2 AST-ST Tigecycline directly with the CLSI broth microdilution reference method.

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

A MRMC comparative effectiveness study was not conducted. This device is an automated system for antimicrobial susceptibility testing, not an imaging diagnostic tool that typically involves human readers.

6. Standalone Performance:

Yes, a standalone performance study was conducted. The VITEK® 2 AST-ST Tigecycline's performance was compared directly to the CLSI broth microdilution reference method without human-in-the-loop intervention.

7. Type of Ground Truth Used:

The ground truth was established using the CLSI broth microdilution reference method, which is a widely accepted laboratory standard for determining minimum inhibitory concentrations (MICs) of antimicrobials.

8. Sample Size for the Training Set:

The document does not explicitly state the sample size used for the training set. It mentions "an external evaluation was conducted," implying a test set, but no separation of a training set is detailed.

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

As the document does not explicitly detail a separate training set, the method for establishing ground truth for a training set is not provided. It is assumed that the development of the VITEK® 2 system itself would have involved extensive calibration and validation against reference methods during its initial design, but specifics for this particular submission are focused on the external evaluation/test set.

Summary

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K131779.

OCT 1 0 2013

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510(k) SUMMARY

VITEK® 2 AST-ST Tigecycline

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Nathan HardestyStaff Regulatory Affairs Specialist
Phone Number:	314 -731-8666
Fax Number:	314-731-8689

May 31, 2013

B. Device Name:

Formal/Trade Name:

Date of Preparation:

Classification Name:

21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Product Code LON

Common Name:

C. Predicate Device:
VITEK 2 AST-ST Linezolid (K111599)

VITEK® 2 AST-ST Tigecycline

D. 510(k) Summary:

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

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

Page 200

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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.

VITEK® 2 AST-ST Tigecvoline 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 AST-ST Tigecycline. 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 AST-ST Tigecycline by comparing its performance with the CLSI broth microdilution reference method incubated at 20 - 24 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK 2 AST-ST Tigecycline demonstrated acceptable performance of 99.8% overall category agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hompshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

BIOMERIEUX, INC. MR. NATHAN HARDESTY 595 ANGLUM RD. HAZELWOOD MO 63042

October 10, 2013

Re: K131779

Trade/Device Name: VITEK 2 AST-ST Tigecycline Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: II Product Code: LON Dated: October 04, 2013 Received: October 08, 2013

Dear Mr. Hardesty:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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 1000-1050.

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Page 2-Mr. Hardesty

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sally A[unclear]ivat -S

Sally A. Hojvat 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):_________K131779

Device Name: VITEK® 2 AST-ST Tigecycline ( ≤ 0.06 -> 1 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 Diagnostics and Radiological Health (OIR)

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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.”