VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole is designed for antimicrobial susceptibility testing of Gram-negative bacilli. VITEK 2 Gram Negative Trimethoprim/ sulfamethoxazole is a qualitative 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. Trimethoprim/sulfamethoxazole 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

Escherichia coli (including susceptible enterotoxigenic strains implicated in traveler's diarrhea) Klebsiella species Proteus mirabilis Enterobacter species Shigella flexneri Morganella morganii Shigella sonnei Proteus vulgaris

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 agalactiae, S. pneumoniae and clinically significant yeast.

Device Description

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 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 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 a breakdown of the acceptance criteria and study information for the VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole (SXT) device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria	Reported Device Performance
Overall Category Agreement (VITEK 2 AST-GN SXT vs. CLSI broth microdilution)	Not explicitly stated as a numerical value in this document, but implied to be "acceptable performance" as per the FDA Class II Special Controls Guidance Document. For similar devices, this typically means a high percentage agreement (e.g., >90%).	100% Overall Category Agreement
Reproducibility	Not explicitly stated, but implied to be "acceptable results".	Acceptable results
Quality Control	Not explicitly stated, but implied to be "acceptable results".	Acceptable results

Note: The document states that the device 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 February 5, 2003." This guidance document would contain the specific numerical acceptance criteria.

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

Sample Size: Not explicitly stated as a numerical count of isolates. The text mentions "fresh clinical isolates and stock challenge strains."
Data Provenance: Not explicitly stated (e.g., country of origin). The study was an "external evaluation." It is common for these types of studies to be multi-center and potentially international, but this document does not specify. The data included both "fresh clinical isolates" (prospective or recent retrospective) and "stock challenge strains."

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 reference method, CLSI broth microdilution, is a standardized laboratory method, so the "experts" would likely be trained microbiologists or laboratory technicians performing this gold standard method.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable in the traditional sense. The ground truth was established by the CLSI broth microdilution reference method, which is a standardized quantitative method that produces a definitive result (MIC value). Discrepancies would be resolved by retesting or further investigation according to laboratory protocols, rather than expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is an automated antimicrobial susceptibility test system, not an imaging or diagnostic device requiring human interpretation of results. The comparison was between the automated system's results and a reference laboratory method (CLSI broth microdilution).

6. If a Standalone Performance Study Was Done

Yes, a standalone study was done. The study evaluated the VITEK 2 Gram Negative SXT device's performance (algorithm only) by comparing its results directly to the CLSI broth microdilution reference method. This assesses the algorithm's accuracy without human intervention influencing the result.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth was established by the CLSI broth microdilution reference method. This is considered a gold standard laboratory method for determining minimum inhibitory concentrations (MICs) of antimicrobials.

8. The Sample Size for the Training Set

Sample Size: Not specified. The document only discusses the "external evaluation" for performance assessment. Information about the training set size is not provided in this 510(k) summary.

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

How Ground Truth for Training Set Was Established: Not specified. As the training set information is not provided, neither is the method for establishing its ground truth.

Summary

{0}------------------------------------------------

KII0106

Image /page/0/Picture/1 description: The image shows the logo for bioMérieux. The logo consists of a stylized globe split into two halves, one with horizontal lines and the other solid black. A curved line passes vertically through the center of the globe. Below the globe, the text "BIOMÉRIEUX" is displayed in a stylized font.

NOV 3 0 2011

510(k) SUMMARY

VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole (SXT)

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Jolyn TenlladoSenior Manager, Regulatory Affairs
Phone Number:	314 -731-8386
Fax Number:	314-731-8689
Date of Preparation:	December 21, 2010
Device Name:
Formal/Trade Name:	VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole(≤ 1/19 - ≥ 16/304 µg/ml)
Classification Name:	Fully Automated Short-Term Incubation Cycle AntimicrobialSusceptibility Device, 21 CFR 866.1645
Common Name:	VITEK 2 AST-GN SXT
Predicate Device:	VITEK 2 Gram Negative Meropenem K091899

D. 510(k) Summary:

в.

VITEK® 2 Gram Negative SXT 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 SXT is a qualitative test. SXT 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

Escherichia coli (including susceptible enterotoxigenic strains implicated in traveler's diarrhea) Klebsiella species

Enterobacter species Morganella morganii Proteus vulgaris

Proteus mirabilis Shigella flexneri Shigella sonnei

p. 264

{1}------------------------------------------------

VITEK 2 Gram Negative SXT 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 February 5, 2003.

The Premarket Notification [510(k)] presents data in support of VITEK 2 Gram Negative SXT. An external evaluation was conducted with fresh clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Negative SXT by comparing its performance with the CLSI broth microdilution reference method. The data is representative of performance on both the VITEK 2 and VITEK 2 Compact instrument platforms. VITEK 2 Gram Negative SXT demonstrated acceptable performance of 100% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results using both the VITEK 2 and VITEK 2 Compact instrument systems.

{2}------------------------------------------------

10903 New Hampshire Avenue Silver Spring, MD 20993

NOV 3 0 2011

bioMérieux, Inc. c/o Jolyn Tenllado Senior Manager, Regulatory Affairs 595 Anglum Road Hazelwood, Missouri 63042-2320

Re: K110106

Trade/Device Name: VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole (< 1/19 -> 16/304 ug/ml) Regulation Number: 21 CFR$ 866.1645 Regulation Name: Short-Term Antimicrobial Susceptibility Test System Regulatory Class: Class II Product Code: LON Dated: November 10, 2011 Received: November 14, 2011

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter

{3}------------------------------------------------

Page 2 - Jolyn Tenllado

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 Parts 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 vours,

Scila Afta

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

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):__K // O/O6

Device Name: VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole (< 1/19 - > 16/304 ug/ml)

Indications For Use:

Active in vitro and in clinical infections

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)

Luddei tu pocte
Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110166

p. 10

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.”