VITEK 2 GRAM POSITIVE LINEZOLID

K032766 · bioMerieux, Inc. · LON · Oct 31, 2003 · Microbiology

Device Facts

• Record ID: K032766
• Device Name: VITEK 2 GRAM POSITIVE LINEZOLID
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Oct 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

VITEK® 2 Gram Positive Linezolid is designed for antimicrobial susceptibility testing of Enterococcus faecalis, E. faecium, Staphylococcus aureus, S. epidermidis, S. haemolyticus and Streptococcus agalactiae. It is intended for use with the VITEK® 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

Device Story

VITEK®2 Gram Positive Linezolid card performs automated antimicrobial susceptibility testing (AST). Input: pure culture organism suspension in saline (standardized to McFarland 0.5). Process: card contains 64 microwells with premeasured antibiotic and culture medium; instrument automatically fills, seals, and incubates cards at 35.5°C; optical scanning measures light transmittance every 15 minutes to monitor growth. Output: MIC result and category interpretation. Used in clinical laboratories; operated by lab personnel. Benefits: rapid, automated determination of bacterial susceptibility to linezolid, aiding clinical antibiotic selection.

Clinical Evidence

External evaluation conducted using fresh and stock clinical isolates and stock challenge strains. Performance compared against NCCLS microbroth dilution reference method. Results demonstrated 98.7% overall Essential Agreement. Reproducibility and Quality Control testing yielded acceptable results.

Technological Characteristics

VITEK®2 test card with 64 microwells; transmittance optics for growth detection; microdilution MIC technique; automated vacuum filling and sealing; incubation at 35.5°C; discriminant analysis algorithm for MIC calculation.

Indications for Use

Indicated for testing linezolid at concentrations of 0.5, 1, and 2 ug/ml for a calling range of ≤ 0.5 – ≥ 8 ug/ml in Staphylococcus spp., Enterococcus spp., and S. agalactiae.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• VITEK®2 Gram Positive Susceptibility Card for Norfloxacin (N50510/S110)

Submission Summary (Full Text)

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K032766

OCT 3 1 2003

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# 510(k) SUMMARY

## VITEK® 2 Gram Positive Linezolid

### A. Submitter Information:

| Submitter's Name: | bioMérieux, Inc. |
|----------------------|-----------------------------------------------------|
| Address: | 595 Anglum Road<br>Hazelwood, MO 63042 |
| Contact Person: | Nancy Weaver<br>Staff Regulatory Affairs Specialist |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date of Preparation: | September 3, 2003 |

#### B. Device Name:

| Formal/Trade Name: | VITEK® 2 Gram Positive Linezolid (0.5 - 2.0 µg/ml) |
|----------------------|-----------------------------------------------------------------------------------------------------|
| Classification Name: | Fully Automated Short-Term Incubation Cycle Antimicrobial<br>Susceptibility Device, 21 CFR 866.1645 |
| Common Name: | VITEK 2 AST-GP Linezolid |
| Predicate Device: | VITEK® 2 Gram Positive Susceptibility Test for Norfloxacin<br>(N50510/S110) |

#### D. 510(k) Summary:

C.

VITEK® 2 Gram Positive Linezolid is designed for antimicrobial susceptibility testing of Enterococcus faecalis, E. faecium, Staphylooocus aureus, S. epidermidis, S. haemolyticus and Streptococus agalactiae. It is intended for use with the VITEK 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. 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) my microdilution methodology.

The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% 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 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.

VITEK 2 Gram Positive Linezolid demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution method, as defined in the Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; guidance for Industry and FDA. Issued February 5, 2003.

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The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive Quinupristin/ dalfopristin. An external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Positive Linezolid by comparing its performance with the NCCLS microbroth dilution reference method. VITEK 2 Gram Positive Linezolid demonstrated acceptable performance of 98.7% overall Essential Agreement when compared to the microbroth dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.

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Public Health Service

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OCT 3 1 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Nancy Weaver Staff Regulatory Affairs Specialist BioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320

k032766 Re:

Trade/Device Name: VITEK 2® Gram Positive Linezolid (0.5-2.0 ug/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: September 3, 2003 Received: September 5, 2003

Dear Ms. Weaver:

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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number (if known): KO327bb

Device Name: VITEK® 2 Gram Positive Linezolid (0.5 – 2.0 µg/ml)

Indications for Use:

VITEK® 2 Gram Positive Linezolid is designed for antimicrobial susceptibility testing of Enterococcus faecalis, E. faecium, Staphylococcus aureus, S. epidermidis, S. haemolyticus and Streptococcus agalactiae. It is intended for use with the VITEK® 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Luddi h. Poole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k032764

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