VITEK 2 GRAM POSITIVE GATIFLOXACIN

K032314 · bioMerieux, Inc. · LON · Aug 22, 2003 · Microbiology

Device Facts

• Record ID: K032314
• Device Name: VITEK 2 GRAM POSITIVE GATIFLOXACIN
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Aug 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

VITEK® 2 Gram Positive Gatifloxacin is designed for antimicrobial susceptibility testing of Staphylococcus aureus (methicillin susceptible strains only) and Staphylococcus saprophyticus. 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 Gatifloxacin test card; 64 microwells containing culture medium and pre-measured gatifloxacin. Input: organism suspension in 0.45-0.5% saline, standardized to McFarland 0.5. Process: VITEK® 2 instrument automatically dilutes, vacuum-fills, and seals cards; incubates at 35.5°C; performs optical scanning every 15 minutes. Principle: transmittance optics measure light blockage by organism growth. Output: MIC values and category interpretations (S, I, R). Used in clinical laboratories; operated by technicians. Healthcare providers use MIC results to guide antimicrobial therapy decisions. Benefits: automated, standardized susceptibility testing for specific Staphylococcus species.

Clinical Evidence

Method comparison study using 365 Staphylococcus isolates (clinical and challenge) compared to NCCLS M7 agar dilution reference method. Results: 99.5% Essential Agreement (EA) and 80.5% Category Agreement (CA). Minor discrepancies noted; no very major discrepancies. Reproducibility >95% across three sites using both manual and automatic dilution methods.

Technological Characteristics

Miniaturized doubling dilution AST card for use with VITEK 2 System. Sensing principle: automated optical monitoring of bacterial growth in wells over 18 hours. Connectivity: integrated with VITEK 2 System. Software: automated incubation and MIC calculation.

Indications for Use

Indicated for antimicrobial susceptibility testing of Staphylococcus aureus (methicillin-susceptible strains) and Staphylococcus saprophyticus. For professional laboratory use as an aid in determining in vitro susceptibility to antimicrobial agents.

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 Sparfloxacin (N50510/S141)

Submission Summary (Full Text)

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K032314

AUG 2 2 2003

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# 510(k) SUMMARY

### VITEK® 2 Gram Positive Gatifloxacin

#### 510(k) Submission 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: | 314-731-8695 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | July 18, 2003 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 Gram Positive Gatifloxacin |
| Classification Name: | Fully Automated Short-Term Incubation Cycle<br>Antimicrobial Susceptibility Device,<br>21 CFR 866.1645 |
| Common Name: | VITEK 2 AST-GP Gatifloxacin |
| C. Predicate Device: | VITEK 2 Gram Positive AST Panel for<br>Sparfloxacin (N50510/S141) |

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

VITEK® 2 Gram Positive Gatifloxacin is designed for antimicrobial susceptibility testing of Staphylococcus aureus and Staphylococcus saprophyticus. 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) 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

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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 Gatifloxacin demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution method, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial susceptibility Devices", dated March 8, 2000 and Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA. Issued Feb. 5, 2003.

The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive Gatifloxacin.

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 Gatifloxacin by comparing its performance with the NCCLS agar dilution reference method. VITEK 2 Gram Positive Gatifloxacin demonstrated acceptable performance of 99.5% overall Essential Agreement when compared to the agar dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

AUG 2 2 2003

Food and Drug Administrati 2098 Gaither Road Rockville MD 20850

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

Re: k032314

Trade/Device Name: VITEK® 2 Gram Positive Gatifloxacin (0.5-4 µg/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: July 24, 2003 Received: July 28, 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): K032314

Device Name: VITEK® 2 Gram Positive Gatifloxacin (0.5 – 4 µg/ml)

Indications for Use:

VITEK® 2 Gram Positive Gatifloxacin is designed for antimicrobial susceptibility testing of Staphylococcus aureus (methicillin susceptible strains only) and Staphylococcus saprophyticus. 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)

Prescription Use
Per 21 CFR 801.109)

Saugmats 8/22/03

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Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032314

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