VITEK® 2 Streptococcus Trimethoprim / Sulfamethoxazole is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 Streptococcus 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 and Sulfamethoxazole have been shown to be active against most strains of the following microorganism, according to the FDA label for this antimicrobial.

Active In Vitro and in Clinical Infections against:

Streptococcus pneumoniae

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 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

Acceptance Criteria and Study for VITEK® 2 AST-ST Trimethoprim / Sulfamethoxazole

This report summarizes the acceptance criteria and the study conducted to prove the VITEK® 2 AST-ST Trimethoprim / Sulfamethoxazole device meets these criteria, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Overall Category Agreement	96.1% with the reference method
Reproducibility	Acceptable
Quality Control	Acceptable

Note: The specific numerical acceptance criteria for "Reproducibility" and "Quality Control" are not explicitly stated in the provided text, only that the results were "acceptable."

2. Sample Size and Data Provenance

Test Set Sample Size: Not explicitly stated as a single number. The study used "fresh and stock clinical isolates, as well as a set of challenge strains." The exact number of each type of isolate is not provided.
Data Provenance: The text does not specify the country of origin for the clinical isolates. It refers to "external evaluation," suggesting data collected from external sites. The study was retrospective, using "fresh and stock clinical isolates" that were pre-existing.

3. Number of Experts and Qualifications for Ground Truth

The provided text does not mention the use of human experts to establish ground truth for the test set. The ground truth was established by a reference method.

4. Adjudication Method for the Test Set

The provided text does not mention an adjudication method involving experts. The comparison was directly to a reference method.

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

An MRMC comparative effectiveness study was not performed. This device is an automated, standalone diagnostic system for antimicrobial susceptibility testing, not designed to assist human readers in interpretation.

6. Standalone Performance

Yes, a standalone performance study was done. The VITEK® 2 AST-ST Trimethoprim / Sulfamethoxazole device's performance was compared directly against the CLSI broth microdilution reference method, which represents the algorithm's performance without human intervention in the interpretation phase beyond loading and starting the system.

7. Type of Ground Truth Used

The ground truth used was the CLSI broth microdilution reference method. This is a laboratory-based, internationally recognized standard method for determining minimum inhibitory concentrations (MICs) of antimicrobials.

8. Sample Size for the Training Set

The provided text does not specify a separate training set sample size. The study describes an "external evaluation" where performance was compared to a reference method. For a device like VITEK® 2, the development and internal validation (which might involve data analogous to a training set) would likely occur prior to the external evaluation described for regulatory submission. However, details of any specific training set are not provided in this summary.

9. How Ground Truth for the Training Set Was Established

As no specific training set is mentioned, the method for establishing its ground truth is also not provided. It is assumed that any internal development or training would also rely on established reference methods like CLSI broth microdilution.

Summary

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K113.305

Image /page/0/Picture/1 description: The image shows the logo for bioMerieux. The logo consists of a circle that is split in half, with one half being filled with horizontal lines and the other half being solid black. A curved line runs vertically through the center of the circle and extends above and below it. The text "BIOMÉRIEUX" is written in all caps below the circle.

FEB 1 0 2012

510(k) SUMMARY

VITEK® 2 AST-ST Trimethoprim / Sulfamethoxazole

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:	November 4th, 2011
1. Device Name:
Formal/Trade Name:	VITEK® 2 Streptococcus Trimethoprim / Sulfamethoxazole
Classification Name:	21 CFR 866.1645Antimicrobial Susceptibility TestProduct Code LON
Common Name:	VITEK® 2 AST-ST Trimethoprim / Sulfamethoxazole (SXT)
Predicate Device:	VITEK® 2 AST-GP Amoxicillin for S. pneumoniae (K063597)

D. 510(k) Summary:

Trimethoprim and Sulfamethoxazole have been shown to be active against most strains of the following microorganism, according to the FDA label for this antimicrobial.

Active In Vitro and in Clinical Infections against:

Streptococcus pneumoniae

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, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.

bioMérieux, Inc. Phone: 314/731-8500 800/638-4835 Fax: 314/731-8700 595 Anglum Road, Hazelwood, Missouri 63042-2320, USA http://www.biomerieux-usa.com Page 176

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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.

VITEK® 2 AST-ST Trimethoprim / Sulfamethoxazole 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 Trimethoprim / Sulfamethoxazole. 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 Trimethoprim / Sulfamethoxazole 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 AST-ST Trimethoprim / Sulfamethoxazole demonstrated acceptable performance of 96.1% 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 1 0 2012

Re: K113305 Trade Name: VITEK®2 Streptococcus Trimethoprim/Sulfamethoxazole Regulation Number: 21 CFR §866.1645 Antimicrobial Susceptibility Test Regulation Name: Regulatory Class: Class II Product Code: LON Dated: November 4, 2011 Received: November 9, 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 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 – Debra J. Rasmussen

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 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,

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): _

K 113305

Device Name: VITEK® 2 Streptococcus Trimethoprim / Sulfamethoxazole (≤ 10(0.5/9.5) - ≥ 320(16/304) µg/mL)

Indications For Use:

Trimethoprim and Sulfamethoxazole have been shown to be active against most strains of the following microorganism, according to the FDA label for this antimicrobial.

Active In Vitro and in Clinical Infections against:

Streptococcus pneumoniae

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)

Ludduite Poole

on Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113305

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.”