VITEK® 2 AST Streptococcus Vancomycin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 AST Streptococcus Vancomycin is a quantitative test intended for use with the VITEK® 2 and ViTEK® 2 Compact Systems as a laboratory aid in th determination of in vitro susceptibility to antimicrobial agents. Vancomycin 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 Viridans group streptococci

In vitro data are available, but their clinical significance is unknown Streptococcus agalactiae Streptococcus pyogenes

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System as an automated method for 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 antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/m). 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 a summary of the acceptance criteria and study details for the VITEK® 2 AST Streptococcus Vancomycin, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Overall Category Agreement (against CLSI broth microdilution reference method)	100%
Reproducibility	Acceptable results
Quality Control	Acceptable results

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated, but the study involved "fresh clinical isolates and stock challenge strains."
- Data Provenance: Not explicitly stated, but the study was an "external evaluation," suggesting data collected outside of bioMérieux's direct control, likely from various clinical settings. No country of origin is specified, but the submission is to the US FDA. The isolates included "fresh clinical isolates," indicating a prospective element, and "stock challenge strains," which could be considered retrospective or pre-existing.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided in the document. The ground truth was established by a reference method.
Adjudication Method for the Test Set:
- None mentioned. The comparison was directly against the CLSI broth microdilution reference method.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was mentioned. The study focused on the performance of the automated system against a reference method, not on human reader improvement with or without AI assistance.
Standalone Performance (Algorithm Only, No Human-in-the-Loop):
- Yes, a standalone performance evaluation was conducted. The VITEK® 2 AST Streptococcus Vancomycin system, which is a "fully automated short-term incubation cycle antimicrobial susceptibility device," was compared directly to the CLSI broth microdilution reference method. This evaluates the algorithm's (and instrument's) performance without human interpretation as part of the core measurement.
Type of Ground Truth Used:
- Reference Method: The ground truth was established using the CLSI broth microdilution reference method, which is a widely accepted laboratory standard for determining antimicrobial susceptibility.
Sample Size for the Training Set:
- This information is not provided in the document. The document describes the validation study (test set), but not the training of the underlying algorithms, which is typical for 510(k) summaries where the focus is on performance validation.
How the Ground Truth for the Training Set Was Established:
- This information is not provided in the document, as the training set details are not discussed.

Summary

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K121/000

RIEUX

510(k) SUMMARY

VITEK® 2 AST Streptococcus Vancomycin

NOV 1 9 2012

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Jocelyn Jennings
	Senior Manager, Regulatory Affairs
Phone Number:	919-620-2894
Fax Number:	919-620-2548
Date of Preparation:	April 5, 2012
B. Device Name:
Formal/Trade Name:	VITEK® 2 AST Streptococcus Vancomycin(< 0.125 - 8 ug/ml)
Classification Name:	Fully Automated Short-Term Incubation Cycle AntimicrobialSusceptibility Device, 21 CFR 866.1645
Common Name:	VITEK 2 AST-ST Vancomycin
C. Predicate Device:	VITEK 2 AST-GP Amoxicillin K063597

D. 510(k) Summary:

VITEK® 2 AST Streptococcus Vancomycin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 AST Streptococcus Vancomycin is a quantitative test intended
for use with the VITEK® 2 and ViTEK® 2 Compact Systems as a laboratory aid in th determination of in vitro susceptibility to antimicrobial agents. Vancomycin 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 Viridans group streptococci

In vitro data are available, but their clinical significance is unknown Streptococcus agalactiae Streptococcus pyogenes

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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VITEK 2 AST Streptococcus Vancomycin 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 Streptococcus Vancomvoin. An external evaluation was conducted with fresh clinical isolates and stock challence strains. The external evaluations were designed to confirm the acceptability of VITEK 2 AST Streptococcus Vancomycin 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 Streptococcus Vancomycin demonstrated acceptable performance of 100% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results using both the VITEK 2 Compact instrument systems.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus, with three vertical lines and a serpentine form at the bottom.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

bioMerieux, Inc. C/O Jocelyn Jennings, Senior Manager, Regulatory Affairs 595 Anglum Road Hazelwood MO 63042

NOV 1 9 2012

Re: K121100

VITEK®2 AST Streptococcus Vancomycin Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON Dated: November 8, 2012 Received: November 9, 2012

Dear Ms. Jennings:

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 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - [Ms. Jennings]

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.

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 Diagnostics and Radiological Health 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

Sally A. Hojvat, M.Sc., Ph.D. 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):_k121100

Device Name: VITEK®2 AST Streptococcus Vancomycin (≤ 0.125 - 8 µg/mL)

Indications For Use:

VITEK® 2 AST Streptococcus Vancomycin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 AST Streptococcus Vancomycin is a quantitative test intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the for ass with the VTTER 2 and VTER 2 otimicrobial agents. Vancomycin has been shown to be a fan this detentified of in 'ntro's strains of the microorganisms listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections Viridans group streptococci

In vitro data are available, but their clinical significance is unknown Streptococcus agalactiae Streptococcus pyogenes

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 The VT LN 27 kitimilloredial outdative 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.

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)

foaia
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K121100

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.”