VITEK® 2 Streptococcus Inducible Clindamycin Resistance is designed for antimicrobial susceptibility testing of Streptococcus agalactiae and Streptococcus pyogenes. VITEK® 2 Streptococcus Inducible Clindamycin Resistance is a qualitative test. 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 VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 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 yeast.

Device Description

The antimicrobial presented in VITEK® 2 AST-ST Cards are 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 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 automatically fills, seas and places the card into the incubator/reader. The VITE variet 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 antimicrobial contained on the card.

AI/ML Overview

Acceptance Criteria and Device Performance Study for VITEK® 2 Streptococcus Inducible Clindamycin Resistance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Acceptable overall category agreement with CLSI Interpretive Criteria	99.2% overall category agreement with the reference method (CLSI Interpretive Criteria, incubated at 24 hours).
Acceptable Reproducibility	Demonstrated acceptable results.
Acceptable Quality Control	Demonstrated acceptable results.

2. Sample Size and Data Provenance

Test Set Sample Size: The document does not explicitly state the exact numerical sample size for the test set. It mentions "fresh and stock clinical isolates, as well as a set of challenge strains" were used in an external evaluation.
Data Provenance: The data used for the study was from "fresh and stock clinical isolates, as well as a set of challenge strains." The document does not specify the country of origin, but it is implied to be clinical isolates, likely from the United States given the FDA submission. The study involved both prospective (fresh clinical isolates) and retrospective (stock clinical isolates) elements.

3. Number, Qualifications, and Adjudication Method of Experts for Ground Truth

The document does not specify the number of experts used to establish the ground truth or their qualifications.
The document does not specify the adjudication method used.

4. MRMC Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed (or at least not reported in this summary). This device is an automated antimicrobial susceptibility test system, not an AI system designed to assist human readers in interpretation.

5. Standalone Performance Study

A standalone performance study was performed. The "VITEK® 2 Streptococcus Inducible Clindamycin Resistance" system itself was evaluated for its performance against the CLSI Interpretive Criteria. The reported 99.2% overall category agreement is a measure of the algorithm's standalone performance.

6. Type of Ground Truth Used

The ground truth used was the CLSI Interpretive Criteria. This refers to established guidelines and standards from the Clinical and Laboratory Standards Institute for interpreting antimicrobial susceptibility test results. The reference method involved incubation at 24 hours.

7. Sample Size for Training Set

The document does not specify the sample size used for the training set.

8. How Ground Truth for Training Set Was Established

The document does not specify how the ground truth for the training set was established. However, given the nature of AST systems, the training data would typically also be based on established reference methods and interpretive criteria, likely CLSI or similar.

Summary

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KIN 909

Image /page/0/Picture/1 description: The image shows the logo for bioMerieux. The logo consists of a stylized globe with half of it shaded with horizontal lines and the other half shaded black. The company name "BIOMERIEUX" is written in a stylized font below the globe.

OCT 1 8 2011

510(k) SUMMARY

VITEK® 2 Streptococcus Inducible Clindamycin Resistance

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Nathan HardestySenior Regulatory Affairs Specialist
Phone Number:	314 - 731-8666
Fax Number:	314-731-8689
Date of Preparation:	June 30, 2011
Device Name:
Formal/Trade Name:	VITEK® 2 Streptococcus Inducible Clindamycin Resistance
Classification Name:	21 CFR 866.1645Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility SystemProduct Code LON
Common Name:	VITEK® 2 AST-ST Inducible Clindamycin Resistance
Predicate Device:	VITEK® 2 Gram Positive Inducible Clindamycin Resistance(K080201)

D. 510(k) Summary:

VITEK® 2 Streptococcus Inducible Clindamycin Resistance is designed for antimicrobial susceptibility testing of Streptococcus agalactiae & Streptococcus pyogenes. VITEK® 2 Streptococcus Inducible Clindamycin Resistance is a qualitative test. 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.

bioMérieux, Inc.

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

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Page 159

VITEK® 2 Streptococcus Inducible Clindamycin Resistance demonstrated substantially equivalent performance when compared with the CLSI Interpretive Criteria, 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 Streptococcus Inducible Clindamycin Resistance. 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 Streptococcus Inducible Clinidamycin Resistance by comparing its performance with the CLSI Interpretive Criteria incubated at 24 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 Streptococcus Inducible Clindamycin Resistance demonstrated acceptable performance of 99.2% overall category agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.

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TPLC Detailed View

Product Code Manufacturer Class Regulation Device Classification Device Name Date Last Listed Not Listed

t listed

CDRH Gen Docs without Manufacturer (None)

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Premarket Reviews Completed (None)

Under Review, Withdrawn or Closed without Product Code (None)

Standards and Guidance (None)

MDR Summary (None)

MDR Analyst (None)

MDR Distribution by Brand - Death or Injury (None)

Patient Problems (None)

Patient Outcomes (None)

Device Problems (None)

Manufacturer Evaluation Results (None)

Manufacturer Evaluation Conclusions (None)

Recalls (None)

Inspections (None)

CDRH Gen Docs without Manufacturer (None)

Rad Health Reports (None)

Rad Health Correspondence (None)

Rad Health Adverse Events (None)

Rad Health EIRs (None)

http://bi.fda.gov/businessobjects/enterprise115/desktoplaunch/viewers/cdz_adv/report.jsp?... 8/25/2011

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data last refreshed on 08/25/2011 08:16 AM

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Druq Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

OCT 1 8 2011

bioMérieux, Inc. c/o Nathan Hardesty Sr. Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042

Re: K111909

Trade/Device Name: VITEK® 2 Streptococcus Inducible Clindamycin Resistance Regulation Number: 21 CFR& 866.1645 Regulation Name: Short-Term Antimicrobial Susceptibility Test System Regulatory Class: Class II Product Code: LON Dated: October 17, 2011 Received: October 17, 2011

Dear Mr. Hardesty:

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

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Page 2 – Nathan Hardesty

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 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 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): 长川|969

Device Name: VITEK® 2 Streptococcus Inducible Clindamycin Resistance

Indications For Use:

VITEK® 2 Streptococcus Inducible Clindamycin Resistance is designed for antimicrobial VITEK® 2 susceptibility testing of Streptococcus agalactiae and Streptococcus pyogenes. Streptococcus Inducible Clindamycin Resistance is a qualitative test. 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.

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)

Luddeke Poole
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K111969

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.”