VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM

K042963 · bioMerieux, Inc. · LON · Dec 13, 2004 · Microbiology

Device Facts

• Record ID: K042963
• Device Name: VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Dec 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2
• Attributes: AI/ML

AI Performance

Output	Acceptance	Observed	Dev DS	Test DS
Antimicrobial Susceptibility Testing (Ertapenem) for Staphylococcus spp.	Essential Agreement (EA) > 90%, Category Agreement (CA) > 90%	Combined EA: 99.5%, Combined CA: 98.4%	Not specified	Clinical study at three sites including 138 clinical isolates and 44 challenge isolates
Antimicrobial Susceptibility Testing (Ertapenem) for Streptococcus agalactiae	Essential Agreement (EA) > 90%, Category Agreement (CA) > 90%	Clinical EA: 100%, Clinical CA: 100%	Not specified	Clinical study at three sites including 59 clinical isolates

Intended Use

The VITEK® Gram Positive 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 Positive Ertapenem is designed for antimicrobial susceptibility testing of Staphylococcus aureus and Streptococcus agalactiae. 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 Positive Susceptibility Card performs automated antimicrobial susceptibility testing (AST). Input: isolated bacterial colonies suspended in 0.45–0.5% saline. Process: vacuum-filled card (45 wells) incubated in VITEK® Reader/Incubator; optical scanner monitors turbidity hourly (6–15 hours). Algorithm: regression analysis and discriminant analysis correlate growth characteristics with MIC values. Output: MIC value and interpretive category (S/I/R). Used in clinical laboratories by technicians; results assist clinicians in selecting appropriate antimicrobial therapy for patients with bacterial infections.

Clinical Evidence

Bench testing only. Performance evaluated using fresh and stock clinical isolates and stock challenge strains. Compared against NCCLS agar dilution reference method. Results demonstrated 99.3% overall Category Agreement. Reproducibility and Quality Control testing yielded acceptable results.

Technological Characteristics

Miniaturized card format for doubling dilution technique. Automated optical growth monitoring. Energy source: VITEK System Reader/Incubator. Connectivity: Integrated with VITEK System. Software: Automated growth threshold detection and MIC calculation.

Indications for Use

Indicated for susceptibility testing of staphylococci, enterococci, and Group B and Group D streptococci to ertapenem (concentrations 2, 4, 8 ug/ml; calling range ≤ 0.5 – ≥ 32 ug/ml). For prescription use.

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 Positive Susceptibility Card for Gatifloxacin (N50510/S143)

Submission Summary (Full Text)

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K042963

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# 510(k) SUMMARY

### VITEK® Gram Positive 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: | October 22, 2004 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® Gram Positive Ertapenem (≤0.5 - ≥32<br>µg/ml) |
| Classification Name: | Fully Automated Short-Term Incubation Cycle<br>Antimicrobial Susceptibility Device,<br>21 CFR 866.1645 |
| Common Name: | VITEK GPS Ertapenem |
| C. Predicate Device: | VITEK Gram Positive Susceptibility (GPS) Card for<br>Gatifloxacin (N50510/S143) |

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

VITEK® Gram Positive Ertapenem is designed for antimicrobial susceptibility testing of Staphyloccocus aureus and Steptococcus agalactiae. 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 GPS Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK GPS Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

After the card is inoculated with a standardized organism suspension, it is placed in the Reader/Incubator of the VITEK System. Organism growth inside the card is optically monitored throughout the 6-15 hour incubation cycle. MIC results are automatically

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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 Positive 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 Positive The Fromanet Notineation (oroly) Pras conducted with fresh and stock clinical isolates and stock challenge strains. The external evaluations were designed to confirm the and otook chairenge birain Positive Ertapenem by comparing its performance with the NCCLS agar dilution reference method. VITEK Gram Positive Ertapenem demonstrated acceptable performance of 99.3% 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of a human figure with an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 3 2004

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

k042963 Re:

Trade/Device Name: VITEK® Gram Positive Ertapenem (≤0.5 - ≥32 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: October 22, 2004 Received: October 27, 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,

Sagaxtys

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): k042963

Device Name: VITEK® Gram Positive Ertapenem (≤0.5 – ≥32 µg/ml)

Indications For Use:

The VITEK® Gram Positive 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 Positive Ertapenem is designed for antimicrobial susceptibility testing of Staphylococcus aureus and Streptococcus agalactiae. 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 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)

Ludlow h. Locke

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Salay

510(k) K04 2963

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