VITEK® 2 Streptococcus Linezolid is designed for antimicrobial susceptibility testing of Streptococcus species 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 Streptococcus Linezolid is a qualitative test. Linezolid 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

Streptococcus agalactiae Streptococcus pneumoniae (including multi-drug resistant isolates [MDRSP]) Streptococcus pyogenes

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 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 in 0.45 - 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 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

Here's a summary of the acceptance criteria and study details for the VITEK® 2 AST-ST Linezolid device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Overall Essential Agreement	99.8%
Overall Category Agreement	99.8%

Note: The specific numerical acceptance criteria (e.g., "should be ≥ 90%") are not explicitly stated in the provided text, only the achieved performance which was deemed "acceptable" and demonstrated "substantially equivalent performance" to the reference method.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of isolates in the provided document. It refers to "fresh and stock clinical isolates" as well as "a set of challenge strains."
- Data Provenance: Not specified (e.g., country of origin). The study involved "an external evaluation." It included both prospective ("fresh clinical isolates") and retrospective ("stock clinical isolates") data, along with "challenge strains."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The ground truth was established by a reference method rather than expert consensus on individual cases.
Adjudication method for the test set:
- Not applicable. The ground truth was established by a single, standardized reference method (CLSI broth microdilution).
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an automated antimicrobial susceptibility testing system, not an AI-assisted diagnostic tool that involves human readers interpreting results.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone study. The VITEK® 2 AST-ST Linezolid system, which is an automated device, was compared directly against the reference method. Its performance figures (Essential and Category Agreement) reflect the algorithm's performance without human intervention in the interpretation process of the device's output.
The type of ground truth used:
- CLSI broth microdilution reference method: This is the gold standard method for determining minimum inhibitory concentrations (MICs) of antimicrobials, as defined by the Clinical and Laboratory Standards Institute (CLSI). The reference method was incubated for 24 hours.
The sample size for the training set:
- The document does not specify a separate "training set" sample size. The VITEK® 2 system is a well-established platform, and the specific VITEK® 2 AST-ST Linezolid card for this antimicrobial likely builds upon existing algorithms. The reported study focuses on validation using the test set described.
How the ground truth for the training set was established:
- Not explicitly stated for a "training set." If a training set was used in the development of the specific Linezolid card (which is likely, but not detailed here), the ground truth would also have been established using a recognized reference method like CLSI broth microdilution.

Summary

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K111899

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 having vertical lines and the other half being solid black. The text "BIOMERIEUX" is written below the circle in a stylized font.

AUG 1 2 2011

510(k) SUMMARY

VITEK® 2 AST-ST Linezolid

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:	April 15, 2011
B.	Device Name:
	Formal/Trade Name:	VITEK® 2 AST-ST Linezolid
	Classification Name:	21 CFR 866.1645Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility SystemProduct Code LON
	Common Name:	VITEK® 2 AST-ST Linezolid
C.	Predicate Device:
		VITEK® 2 Gram Positive Amoxicillin for Streptococcuspneumoniae (K063597)

D. 510(k) Summary:

Active in vitro and in clinical infections Streptococcus agalactiae Streptococcus pneumoniae (including multi-drug resistant isolates [MDRSP]) Streptococcus pvogenes

The antimicrobial presented in VITEK® 2 AST-ST 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.

bioMérieux, Inc.

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

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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, 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 antimicrobial contained on the card.

VITEK® 2 AST-ST Linezolid demonstrated substantially equivalent performance 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 Linezolid. 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 Linezolid by comparing its performance with the CLSI broth microdilution reference method incubated at 24 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK 2 AST-ST Linezolid demonstrated acceptable performance of 99.8% overall essential Agreement and 99.8% overall category agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.

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Image /page/2/Picture/1 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. U.S." arranged around the perimeter. Inside the circle is an abstract symbol of a stylized eagle or bird with its wings spread, representing the department's mission related to health and well-being.

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

BioMerieux Inc. c/o Nathan Hardesty Senior Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042-2320

AUG 12 2011

Re: K111599

Trade/Device Name: VITEK® 2 AST-ST Linezolid Regulation Number: 21 CFR§ 866.1645 Regulation Name: VITEK 2 and VITEK 2 Compact Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: LON Dated: June 3. 2011 Received: June 8, 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 10 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 of medical device-related adverse events) (21 CFR 803); and good manufacturing practice

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Page 2 - Nathan Hardesty

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 vours,

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):

Device Name: VITEK® 2 AST-ST Linezolid ( ≤ 2 − ≥ 8 µg/mL )

Indications For Use:

Active in vitro and in clinical infections

Streptococcus agalactiae Streptococcus pneumoniae (including multi-drug resistant isolates [MDRSP]) Streptococcus pyogenes

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)

Freddie W. Poole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K111599

Page 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.”