VITEK® 2 Gram Negative Doripenem is designed for antimicrobial susceptibility testing of Gram negative microorganisms 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 Gram Negative is a quantitative test. Doripenem has been shown to be active against the microorganisms listed below according to the FDA label for the antimicrobial.

Active in vitro and in clinical infections: Acinetobacter baumannii Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

Active in vitro but clinical significance unknown: Citrobacter freundii Enterobacter cloacae Enterobacter aerogenes Klebsiella oxytoca Serratia marcescens

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 gramnegative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

Device Description

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) microdilution methodology.

The bacterial 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 System 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 antibiotic contained on the card.

AI/ML Overview

Here's an analysis of the provided text, extracting the requested information about the device's acceptance criteria and the supporting study:

VITEK® 2 Gram Negative Doripenem - Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What must be achieved)	Reported Device Performance (What was achieved)
Substantially equivalent performance to CLSI broth microdilution reference method, as defined in FDA Class II Special Controls Guidance Document.	Demonstrated substantially equivalent performance.
Acceptable overall Category Agreement.	97.9% overall Category Agreement.
Acceptable Reproducibility.	Demonstrated acceptable results.
Acceptable Quality Control.	Demonstrated acceptable results.

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

Test Set Sample Size: Not explicitly stated as a single number for total isolates. The study refers to "fresh and stock clinical isolates and stock challenge strains." This suggests a diverse collection, but the exact number is missing.
Data Provenance: The study was an "external evaluation," implying testing conducted outside of bioMérieux's internal labs. There is no explicit mention of the country of origin, but the submission is to the FDA (USA), and the CLSI (Clinical and Laboratory Standards Institute) is a US-based organization, suggesting a US-centric context for the data, or at least data compliant with US standards. The isolates were a mix of "fresh and stock clinical isolates and stock challenge strains," indicating a combination of prospective and retrospective (for stock clinical isolates and challenge strains) data.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. It's implied that the CLSI broth microdilution reference method is the gold standard, and its execution would typically involve trained microbiologists or laboratory personnel experienced in performing and interpreting these reference methods.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. The comparison is directly between the VITEK® 2 system and the CLSI broth microdilution reference method. This direct comparison usually implies that the CLSI method's result is taken as the definitive ground truth without a separate expert adjudication process for discordant results, beyond potentially re-testing by the reference method itself if initial results were unclear.

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

MRMC Study Done: No. This device is an automated antimicrobial susceptibility testing (AST) system, not an imaging or diagnostic device that typically involves human readers interpreting cases. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable here. The comparison is between an automated system and a reference microbiology method.

6. Standalone (Algorithm Only) Performance

Standalone Performance Done: Yes. The entire study focuses on the "standalone" performance of the VITEK® 2 Gram Negative Doripenem system. The system automatically performs the test, interprets the growth, and generates the MIC value and interpretive category without human intervention during the test run or interpretation beyond initial setup and loading. The reported 97.9% overall Category Agreement is a measure of this standalone performance against the reference method.

7. Type of Ground Truth Used

Ground Truth Type: Expert consensus through a reference method. Specifically, the "CLSI broth microdilution reference method," as defined in the FDA Class II Special Controls Guidance Document. This is considered the gold standard for antimicrobial susceptibility testing.

8. Sample Size for the Training Set

Training Set Sample Size: Not explicitly stated. The document describes the external evaluation for validation (test set), but does not detail the size or nature of the data used to initially train or develop the VITEK 2 AST card and its interpretive algorithms.

9. How Ground Truth for the Training Set Was Established

Ground Truth for Training Set Establishment: Not explicitly detailed in the provided summary. However, for AST systems, the ground truth for training (or development/calibration) would similarly be established by comparing the device's readings against established reference methods, like the CLSI broth microdilution method, during the development phase. This process calibrates the system's interpretive algorithms to accurately reflect the true MIC values and interpretive categories.

Summary

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82346 MAR 1 6 2009

BIOMÉRIEUX

510(k) SUMMARY

VITEK® 2 Gram Negative Doripenem

510(k) Submission Information:

bioMérieux, Inc. Submitter's Name: 595 Anglum Road Address: Hazelwood, MO 63042 Contact Person: Jolyn Tenllado Associate Staff Regulatory Affairs Specialist 314 -731-8386 Phone Number. Fax Number: 314-731-8689 August 14, 2008 Date of Preparation: B. Device Name:

Formal/Trade Name: VITEK® 2 Gram Negative Doripenem (≤ 0.12 - ≥ 8 µg/ml) Classification Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Device, 21 CFR 866.1645 VITEK 2 AST-GN Doripenern Common Name: C. Predicate Device: VITEK 2 Gram Negative Levofloxacin (K072038)

D. 510(k) Summary:

VITEK® 2 Gram Negative Doripenem is designed for antimicrobial susceptibility testing of Gram negative microorganisms. 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. Doripenem has been shown to be active against the organisms listed below according to the FDA label for the antimicrobial.

Active in vitro and in clinical infections: Acinetobacter baumannii Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

Active in vitro but clinical significance unknown: Citrobacter freundii Enterobacter cloacae Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Serratia marcescens

bioMérieux, Inc.

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

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VITEK 2 Gram Negative Doripenem 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 March 5, 2007.

The Premarket Notification (510(k)) presents data in support of VITEK 2 Gram Negative Dorioenem. 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 Doripeners by companing its performance with the CLSI broth microditution reference method. The data is representative of performance on both the VITEK 2 Compact instrument platforms, as evidenced in the AST equivalency study presented in the VITEK 2 Compact 510(k), K050002. VITEK 2 Gram Negative Doripenem demonstrated acceptable performance of 97.9% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is centered on the image and is the only element present.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 6 2009

Ms. Jolyn Tenllado Associate Staff Regulatory Affairs Specialist bioMérieux 595 Anglum Road Hazelwood, MO 63042

Re: K082346

Trade/Device Name: VITEK® 2 Gram Negative Doripenem (≤ 0.12 -> 8 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Short-Term Antimicrobial Susceptibility Test System Regulatory Class: Class II Product Code: LON Dated: March 12, 2009 Received: March 13, 2009

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 either class II (Special 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, Code 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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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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)). please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Sally attaym

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

1082346 510(k) Number (if known):

Device Name: VITEK® 2 Gram Negative Doripenem (≤ 0.12 - ≥ 8 µg/ml)

Indications For Use:

Active in vitro and in clinical infections: Acinetobacter baumannii Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

Active in vitro but clinical significance unknown: Citrobacter freundii Enterobacter cloacae Enterobacter aerogenes Klebsiella oxytoca Serratia marcescens

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)

Saiyala
Division Sign-Off

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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.”