VITEK®2 Gram Negative Tigecycline is intended for antimicrobial susceptibility testing of Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Citrobacter koseri, Enterobacter aerogenes, and Serratia marcescens. VITEK 2 Gram Negative Tigecycline is a qualitative test. It is intended for use with the VITEK 2 Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

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 and 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) microdifution methodology. The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% 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 systems monitor 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 antibiotic contained on the card.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance (VITEK 2 Gram Negative Tigecycline)
Overall Category Agreement (with NCCLS/CLSI reference agar dilution method)	91.9%
Reproducibility	Acceptable results
Quality Control	Acceptable results

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

The document states "An external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains." However, it does not explicitly state the specific sample size (number of isolates) used for the test set. It also does not explicitly state the country of origin of the data. The mention of "fresh clinical isolates" suggests some prospective collection, while "stock clinical isolates and stock challenge strains" indicate retrospective or pre-existing samples.

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

The document does not provide information on the number of experts used or their qualifications.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The study compares the device performance to a reference method (NCCLS/CLSI agar dilution), not to human readers with and without AI assistance.

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

Yes, the study describes the standalone performance of the VITEK 2 Gram Negative Tigecycline system, as it compares its output directly to the reference method without human interpretation as part of the evaluated performance metric.

7. The Type of Ground Truth Used:

The ground truth used was the NCCLS reference agar dilution method (later referred to as CLSI agar dilution reference method). This is a well-established laboratory method for determining antimicrobial susceptibility.

8. The Sample Size for the Training Set:

The sample size for the training set is not explicitly mentioned in the provided text. The document focuses on the external evaluation data used for performance validation.

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

The document does not provide information on how the ground truth for the training set was established. It only describes the ground truth used for the external evaluation (NCCLS/CLSI agar dilution method).

Summary

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Image /page/0/Picture/0 description: The image shows a date stamp and a company name. The date stamp reads "SEP 2 9 2005", indicating September 29, 2005. Below the date stamp is the company name "BIOMÉRIEUX" in a stylized font. The image appears to be a scan or photocopy due to the slightly faded and grainy quality.

K0523//

510(k) SUMMARY

VITEK® 2 Gram Negative Tigecycline

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:	August 23, 2005
Device Name:
Formal/Trade Name:	VITEK® 2 Gram Negative Tigecycline (≤0.5 - ≥8µg/ml)
Classification Name:	Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device, 21 CFR866.1645
Common Name:	VITEK 2 AST-GN Tigecycline
Predicate Device:	VITEK 2 Gram Negative Ertapenem (K041982)

D. 510(k) Summary:

VITEK® 2 Gram Negative Tigecycline is designed for antimicrobial susceptibility testing of Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Citrobacter koseri, Enterobacter aerogenes and Serratia marcescens. 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 mog/ml. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdifution methodology.

The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% 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 systems monitor the growth of each well in the card over a defined period of time (up to 18 hours),

bioMérieux, Inc.

595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/638-4835 Fax: 314/731-8700

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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.

VITEK 2 Gram Negative Tigecvoline 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 2 Gram Negative Tigecycline. 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 2 Gram Negative Tigecycline by comparing its performance with the CLSI (formerly NCCLS) agar dilution reference method. VITEK 2 Gram Negative Tigecycline demonstrated acceptable performance of 91.9% overall Category Agreement when compared to the agar dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The caduceus is depicted with a bird-like figure with three lines representing the wings or body, and the text is in a simple, sans-serif font.

SEP 2 9 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K052311

Trade/Device Name: VITEK® 2 Gram Negative Tigecycline (≤0.5 - ≥8 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: August 23, 2005 Received: August 24, 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 cither class II (Spccial 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, Codc 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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Page 2 -

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" (21 CFR 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 Hogg

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

K052311 510(k) Number (if known):

Device Name:_________________ VITEK® 2 Gram Negative (≤0.5 - ≥8 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)

Luddi te. Paole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K05 2311

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.”