VITEK 2 YEAST CASPOFUNGIN

K101566 · bioMerieux, Inc. · NGZ · Sep 28, 2010 · Microbiology

Device Facts

• Record ID: K101566
• Device Name: VITEK 2 YEAST CASPOFUNGIN
• Applicant: bioMerieux, Inc.
• Product Code: NGZ · Microbiology
• Decision Date: Sep 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

VITEK® 2 Yeast Caspofungin is designed for antifungal susceptibility testing of Candida species. VITEK 2 Yeast Caspofungin is a quantitative test intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. Caspofungin has been shown to be active both in vitro and in clinical infections against most strains of the following microorganisms according to the FDA label for the antifungal. Candida albicans Candida glabrata Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis . The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 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, S. pneumoniae and clinically significant yeast.

Device Story

VITEK 2 Yeast Caspofungin is an in vitro diagnostic test for determining minimum inhibitory concentration (MIC) of caspofungin against Candida species. Device uses miniaturized doubling dilution technique within AST cards. Input: isolated yeast colonies diluted in 0.45% saline. Operation: VITEK 2 or VITEK 2 Compact systems automatically fill, seal, and incubate cards; system monitors well growth over 36 hours. Output: MIC value and interpretive category. Used in clinical laboratories by technicians/microbiologists. Results assist clinicians in selecting appropriate antifungal therapy for patients with Candida infections.

Clinical Evidence

External evaluation conducted using fresh and stock clinical isolates and challenge strains. Performance compared against CLSI reference method (24-hour incubation). Results: 99.5% overall essential agreement and 99.8% overall category agreement. Reproducibility and quality control testing demonstrated acceptable performance.

Technological Characteristics

Miniaturized broth microdilution AST card. Automated growth monitoring via VITEK 2/VITEK 2 Compact systems. Quantitative MIC determination. Software-based analysis of growth kinetics.

Indications for Use

Indicated for antifungal susceptibility testing of Candida species (C. albicans, C. glabrata, C. guilliermondii, C. krusei, C. parapsilosis, C. tropicalis) in isolated colonies. For professional laboratory use.

Regulatory Classification

Identification

An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Predicate Devices

• VITEK® 2 Yeast Fluconazole (K061945)

Submission Summary (Full Text)

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K101566
SEP 28 2010

## 510(k) SUMMARY

### VITEK® 2 Yeast Caspofungin

### 510(k) Submission Information:

| Submitter's Name: | bioMérieux, Inc. | |
|-----------------------------------------|--------------------------------------------------------------------------|--|
| Address: | 595 Anglum Road<br>Hazelwood, MO 63042 | |
| Contact Person: | Nancy Weaver<br>Associate Director, Regulatory Affairs | |
| Phone Number: | 314 -731-8695 | |
| Fax Number: | 314-731-8689 | |
| Date of Preparation: | August 06, 2009 | |
| B. Device Name: | | |
| Formal/Trade Name: | VITEK® 2 Yeast Caspofungin | |
| Classification Name: | 21 CFR 866.1640<br>Antimicrobial Susceptibility Test<br>Product Code NGZ | |
| Common Name:VITEK® 2 AST-YS Caspofungin | | |
| C. Predicate Device: | VITEK® 2 Yeast Fluconazole (K061945) | |

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

VITEK® 2 Yeast Caspofungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Caspofungin is a quantitative test intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. Caspofungin has been shown to be active against most strains of the following microorganisms listed below according to the FDA label for the antifungal.

Candida albicans Candida krusei Candida parapsilosis Candida tropicalis Candida lusitaniae Candida quilliermondii

The antifungal 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 isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to TThe ISolate to be tested is different is a carded be normatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 36 hours for

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

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veast). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antifungal contained on the card.

VITEK 2 Yeast Caspofungin demonstrated substantially equivalent performance when compared with the CLSI reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA. Issued Mar. 5, 2007.

The Premarket Notification (510[k]) presents data in support of VITEK® 2 Yeast Caspolungin. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 Yeast Caspofungin by comparing its performance with the CLSI reference method incubated at 24 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms VITEK 2 Yeast Caspofungin demonstrated acceptable performance of 99.5% overall essential Agreement and 99.8% overall category agreement with the reference method incubated for 24 hrs. Reproducibility and Quality Control demonstrated acceptable results.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles connected by flowing lines, creating a sense of unity and movement. The symbol is black, providing a strong contrast against the white background.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Ms. Nancy Weaver Associate Director, Regulatory Affairs bioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042

SEP 2 8 2010

Re: K101566

Trade Name: VITEK®2 Yeast Caspofungin Regulation Number: 21 CFR §866.1640 Antimicrobial susceptibility test powder Regulation Name: Regulatory Class: Class II Product Code: NGZ, LRG Dated: August 11, 2010 Received: August 12, 2010

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section

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Page 2 - Nancy Weaver

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 advice for your device on our labeling regulation (21 CFR Part 801 and 809), 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Liddie Poole

for
Sally A. Hoivat, M.Sc., Ph.D.

Sally A. Hojvat, M.Sc., Ph.I 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): ___k101566____

SEP 2 8 2010

Device Name: VITEK 2 Yeast Caspofungin (0.25 - 4 ug/ml)

Indications For Use:

VITEK® 2 Yeast Caspofungin is designed for antifungal susceptibility testing of Candida species. VITEK 2 Yeast Caspofungin is a quantitative test intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. Caspofungin has been shown to be active both in vitro and in clinical infections against most strains of the following microorganisms according to the FDA label for the antifungal.

Candida albicans Candida glabrata Candida guilliermondii

Candida krusei Candida parapsilosis Candida tropicalis

. The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 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, S. pneumoniae and clinically significant yeast.

Prescription Use × (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)

Freddie L. Poole

vision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K/0 1566

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