VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN

K052656 · bioMerieux, Inc. · LON · Nov 7, 2005 · Microbiology

Device Facts

• Record ID: K052656
• Device Name: VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Nov 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2

Intended Use

VITEK® Gram Positive Daptomycin is designed for antimicrobial susceptibility testing of Enterococcus faecalis, Staphylococcus aureus, Streptococcus agalactiae, Staphylococcus epidermidis and Stapylococcus haemolyticus. VITEK Gram Positive Daptomycin is a qualitative test. It is intended for use with the VITEK System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. 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 clinicant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

Device Story

VITEK Gram Positive Daptomycin is a test card used with the VITEK System for automated antimicrobial susceptibility testing. The card is inoculated with a standardized organism suspension and placed in the VITEK System Reader/Incubator. The system optically monitors organism growth within the card over a 6-15 hour incubation cycle. Once a predetermined growth threshold is reached, the system automatically calculates the Minimum Inhibitory Concentration (MIC) and generates a report with the MIC result and interpretive category. Used in clinical laboratories by trained personnel to determine in vitro susceptibility to antimicrobial agents, the device aids clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections.

Clinical Evidence

Bench testing only. Performance evaluated using fresh and stock clinical isolates and stock challenge strains compared to the CLSI broth microdilution reference method. Results demonstrated 99.5% overall Category Agreement. Reproducibility and Quality Control testing yielded acceptable results.

Technological Characteristics

VITEK 2 card with 45 microwells containing premeasured Daptomycin and culture media. Sensing principle: optical light attenuation (turbidity) to detect bacterial growth. Energy source: VITEK 2 instrument. Connectivity: VITEK 2 system integration. Software: automated growth detection and regression analysis for MIC calculation.

Indications for Use

Indicated for susceptibility testing of Enterococcus faecalis, Staphylococcus aureus, Streptococcus agalactiae, Staphylococcus epidermidis, and Staphylococcus haemolyticus isolates to Daptomycin. Prescription use only. Resistant strains cannot be defined; results suggestive of non-susceptibility require reference laboratory testing.

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 AST Panel for Linezolid (K022045)

Submission Summary (Full Text)

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**NOV - 7 2005**

BIOMÉRIEUX

K052656

# 510(k) SUMMARY

## VITEK® Gram Positive Daptomycin

#### 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: | September 23, 2005 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® Gram Positive Daptomycin (≤0.5-≥16<br>µg/ml) |
| Classification Name: | Fully Automated Short-Term Incubation Cycle<br>Antimicrobial Susceptibility Device,<br>21 CFR 866.1645 |
| Common Name: | VITEK GPS Daptomycin |
| C. Predicate Device: | VITEK Gram Positive Susceptibility (GPS) Card for<br>Linezolid (K022045) |

### D. 510(k) Summary:

B

VITEK® Gram Positive Daptomcyin is designed for antimicrobial susceptibility testing of Enterococcus faecalis, Staphyloccocus aureus, Steptococcus agalactiae, Staphylococcus epidermidis and Staphylococcous haemolyticus. 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

#### bioMérieux, Inc. 595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: [phone]/638-4´¯¯ http://www.biomerieux-usa.com

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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 Daptomycin. 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 Positive Dapytomycin by companing its performance with the CLSI (formerly NCCLS) broth microdilution reference method. VITEK Gram Positive Daptomycin demonstrated acceptable performance of 99.5% overall Category Agreement when compared to the broth microdilution reference method. Reproducibility and Quality Control demonstrated acceptable results.

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Food and Grug Administration 2098 Gaither Road Rockville MD 20850

NOV - 7 2005

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

Re: k052656

> Trade/Device Name: VITEK® Gram Positive Daptomycin (≤0.5 - ≥16 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: September 23, 2005 Received: September 26, 2005

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/industry/support/index.html

Sincerely yours,

Sally a. For

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): K05 a 656

Device Name: VITEK® Gram Positive Daptomycin (<0.5 - ≥16 µg/ml)

Indications For Use:

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

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 clinicant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

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)

Luddie Poole

Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Sulery

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