VITEK GRAM NEGATIVE GATIFLOXACIN

K032711 · bioMerieux, Inc. · LON · Oct 31, 2003 · Microbiology

Device Facts

• Record ID: K032711
• Device Name: VITEK GRAM NEGATIVE GATIFLOXACIN
• 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

The VITEK® Gram Negative Gatifloxacin is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Acinetobacter lwoffii, Citrobacter koseri, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca, Morganella morganii and Proteus vulgaris. It is intended for use with the VITEK® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

Device Story

VITEK® GNS Gatifloxacin card; used with VITEK® System for antimicrobial susceptibility testing (AST). Input: pure culture organism suspension (standardized to McFarland 1). Process: card wells contain premeasured antibiotic concentrations; organism suspension rehydrates medium; incubation at 35.5°C; optical scanner measures light transmittance to detect growth via attenuation. Output: MIC (minimum inhibitory concentration) and category interpretation (S, I, R). Used in clinical laboratories; operated by technicians. System uses discriminate analysis algorithm to determine susceptibility based on growth characteristics. Benefits: provides rapid, automated in vitro susceptibility results to guide antibiotic therapy.

Clinical Evidence

External evaluation conducted using fresh and stock clinical isolates and stock challenge strains. Performance compared to NCCLS agar dilution reference method. Results demonstrated 97.9% overall Essential Agreement. Reproducibility and Quality Control testing yielded acceptable results.

Technological Characteristics

VITEK® card with 30-45 microwells; microdilution technique. Optics system uses visible light transmittance to measure growth. Automated incubation at 35.5°C. Software-based discriminate analysis algorithm. Standardized inoculum preparation via VITEK® Colorimeter.

Indications for Use

Indicated for antimicrobial susceptibility testing of specific Gram-negative bacteria (E. coli, K. pneumoniae, P. mirabilis, A. lwoffii, C. koseri, C. freundii, E. aerogenes, E. cloacae, K. oxytoca, M. morganii, P. vulgaris) in clinical laboratory settings. For prescription use only.

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® Gram Negative Susceptibility Test for Cefpodoxime (N50510/S73)

Submission Summary (Full Text)

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K032711

OCT 3 1 2003

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# 510(k) SUMMARY

## VITEK® Gram Negative 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: | August 29, 2003 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® Gram Negative Gatifloxacin (1.5 - 10 µg/ml) |
| Classification Name: | Fully Automated Short-Term Incubation Cycle<br>Antimicrobial Susceptibility Device, 21 CFR 866.1645 |
| Common Name: | VITEK GNS Gatifloxacin |
| C. Predicate Device: | VITEK® Gram Negative Susceptibility Card -<br>Cefpodoxime (N50510/S073) |

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

B

C

VITEK® Gram Negative Gatifloxacin is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis. Acinetobacter Iwoffii, Citrobacter koseri, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca, Morganella morganii and Proteus vulgaris. It is intended for use with the VITEK® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK GNS Card is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK GNS 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 automatically fills, seals and places the card into the incubator/reader. The VITEK monitors the growth of each well in the card over a defined period of time (up to 15 hours). At the

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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 Gram Negative Gatifloxacin 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, February 5, 2003.

The Premarket Notification (510[k]) presents data in support of VITEK Gram Negative 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 Gram Negative Gatifloxacin by comparing its performance with the NCCLS agar dilution reference method. VITEK Gram Negative Gatifloxacin demonstrated acceptable performance of 97.9% 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

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

Re: k032711

Trade/Device Name: VITEK® Gram Negative Gatifloxacin (1.5-10 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: August 29, 2003 Received: September 2, 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. Iisting 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

KD32711 510(k) Number (if known): _

Device Name: VITEK® Gram Negative Gatifloxacin (1.5 - 10 µg/ml)

Indications for Use:

The VITEK® Gram Negative Gatifloxacin is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Acinetobacter lwoffii, Citrobacter koseri, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca, Morganella morganii and Proteus vulgaris. It is intended for use with the VITEK® 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)

Freddie tur Poole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032711

- For Prescription Use Only