VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM

K043230 · bioMerieux, Inc. · LON · Dec 30, 2004 · Microbiology

Device Facts

• Record ID: K043230
• Device Name: VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Dec 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

The VITEK® Gram Negative Susceptibility Test is intended to be used with the VITEK® System 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 agalactiae, and S. pneumoniae. VITEK® Gram Negative Ertapenem is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca (excluding ESBL producing strains), Morganella morganii, Proteus mirabilis, Proteus vulgaris and Serratia marcescens. VITEK Gram Negative Ertapenem is for qualitative testing only. 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® Gram Negative Susceptibility Card is a 45-well test card used with the VITEK® System. Clinical laboratory personnel inoculate the card with a saline-diluted suspension of isolated gram-negative bacilli using a vacuum filling process. The VITEK® Reader/Incubator optically monitors organism growth via light attenuation in wells over a 6–15 hour incubation cycle. The system uses regression and discriminate analysis to process growth characteristics and organism identification to determine susceptibility results. The device outputs qualitative SIR (Susceptible, Intermediate, Resistant) interpretations. This automated process eliminates manual handling after inoculation, providing standardized susceptibility testing to guide antimicrobial therapy decisions.

Clinical Evidence

External evaluation conducted using fresh and stock clinical isolates and stock challenge strains. Performance compared to NCCLS agar dilution reference method. Results showed 98.7% overall Category Agreement. Reproducibility and Quality Control testing yielded acceptable results.

Technological Characteristics

Miniaturized microdilution card for use with the VITEK System. Automated short-term incubation and growth monitoring. Measures antimicrobial susceptibility via growth threshold detection. Qualitative testing only.

Indications for Use

Indicated for qualitative susceptibility testing (SIR) of rapidly growing aerobic and/or facultatively anaerobic gram-negative bacilli to ertapenem (concentrations 0.5, 1, and 2 µg/mL; calling range ≤0.5 – ≥8 µg/mL). 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 Card for Gatifloxacin (k032711)

Submission Summary (Full Text)

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K043230

DEC 3 0 2004

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# 510(k) SUMMARY

## VITEK® Gram Negative Ertapenem

### 510(k) Submission Information:

| Submitter's Name: | bioMérieux, Inc. |
|----------------------|--------------------------------------------------------------------------------------------------------|
| Address: | 595 Anglum Road<br>Hazelwood, MO 63042 |
| Contact Person: | Jolyn Tenllado<br>Regulatory Affairs Specialist |
| Phone Number: | 314-731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | November 17, 2004 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® Gram Negative Ertapenem (≤0.5 – ≥8<br>$µg/ml$ ) |
| Classification Name: | Fully Automated Short-Term Incubation Cycle<br>Antimicrobial Susceptibility Device,<br>21 CFR 866.1645 |
| Common Name: | VITEK GNS Ertapenem |
| C. Predicate Device: | VITEK Gram Negative Susceptibility (GNS) Card<br>for Gatifloxacin (K032711) |

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

VITEK® Gram Negative Ertapenem is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca (excluding ESBL producing strains), Morganella morganii, Proteus mirabilis, Proteus vulgaris and Serratia marcescens. It is intended for use with the VITEK® System as a laboratory and in the determination of in vitro susceptibility to antimicrobial agents. The antimicry ial presented in VITEK GNS Cards is in concentrations equivalent by efficacy to atandard method concentrations in mcg/ml. The VITEK GNS Cards are essentially miniturized versions of the doubling dilution technique for determining the minimum in hilitory concentration (MIC) microdilution methodology.

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calculated once a predetermined growth threshold is reached, and a report is generated that contains the MIC result and the interpretive category result.

VITEK Gram Negative Ertapenem demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution method, as defined in the FDA 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 Gram Negative Ertapenem. An external evaluation was conducted with fresh and stock clinical isalates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK Gram Negative Ertapenem by comparing its performance with the NCCLS agar dilution reference method. VITEK Gram Negative Ertapenem demonstrated acceptable performance of 98.7% overall Category Agreement when compared to the agar dilution 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 stylized eagle with three wavy lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 3 0 2004

Ms. Jolyn Tenllado Regulatory Affairs Specialist BioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320

Re: k043230

Trade/Device Name: VITEK® Gram Negative Ertapenem (≤0.5 ->>8 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: November 17, 2004 Received: November 22, 2004

Dear Ms. Tenllado:

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). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Saartys

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): k043230

Device Name: VITEK® Gram Negative Ertapenem (≤ 0.5 – ≥ 8 µg/ml)

Indications For Use:

The VITEK® Gram Negative Susceptibility Test is intended to be used with the VITEK® System 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 agalactiae, and S. pneumoniae. VITEK® Gram Negative Ertapenem is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca (excluding ESBL producing strains), Morganella morganii, Proteus mirabilis, Proteus vulgaris and Serratia marcescens. VITEK Gram Negative Ertapenem is for qualitative testing only. It is intended for use with the VITEK System 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)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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KO43230 510(k)_