ETEST VORICONAZOLE 0.002-32 UG/ML

K082534 · Ab Biomerieux · NGZ · Nov 2, 2009 · Microbiology

Device Facts

• Record ID: K082534
• Device Name: ETEST VORICONAZOLE 0.002-32 UG/ML
• Applicant: Ab Biomerieux
• Product Code: NGZ · Microbiology
• Decision Date: Nov 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

This submission is for Etest Voriconazole for MIC determinations across 0.002-32 µg/mL with C. albicans, C. glabrata, C. parapsilosis and C. tropicalis. Etest is an agar-based gradient technique for quantitative antifungal susceptibility testing of Candida species. It uses a predefined concentration gradient of the specific antifungal agent to determine the Minimum Inhibitory Concentration (MIC) in ug/mL inhibiting the growth of the test organism under defined conditions.

Device Story

Etest® is an agar-based gradient strip for quantitative antifungal susceptibility testing. Input: isolated Candida colonies inoculated on agar plates. Operation: plastic strip with predefined exponential gradient of dried Voriconazole applied to inoculated agar; antifungal agent diffuses into agar creating concentration gradient; incubation at 35°C. Output: symmetrical inhibition ellipse intersecting strip at MIC value (µg/mL). Used in clinical laboratories; manual reading by technicians. Benefits: provides discrete MIC values for antifungal susceptibility, aiding clinical decision-making regarding treatment.

Clinical Evidence

No clinical data provided. Performance is based on bench testing for MIC determination of Voriconazole against specified Candida species.

Technological Characteristics

Thin, inert, non-porous plastic strip (5mm x 60mm). Contains predefined exponential gradient of dried antifungal agent. Principle: combination of dilution and diffusion. Manual reading of inhibition ellipse. No electronic components or software.

Indications for Use

Indicated for quantitative antifungal susceptibility testing (MIC determination) of Candida species (C. albicans, C. glabrata, C. parapsilosis, and C. tropicalis) using an agar-based gradient technique. For prescription use only.

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

AB BioMerieux c/o Anette Engelhardt CEO Dalvagen 10 16956 Solna Sweden

NOV - 2 2009

## Re: K082534

Trade/Device Name: E test Voriconazole (0.002-32 mg/ml) Regulation Number: 21CFR 866.1640 Regulation Name: Etest® for Antimicrobial Suspectibility Testing Regulatory Class: Class II Product Code: NGZ Dated: October 2, 2009 Received: October 8, 2009

Dear Ms. Engelhardt

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 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 Part 801); 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.

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Page 2 - Anette Engelhardt

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Jalquitingo

Sally A. Hojvat, 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): K082534

Device Name: Etest Voriconazole - Antifungal Susceptibility Test - MIC at 0.002-32 ug/mL

Indications For Use: This submission is for Etest Voriconazole for MIC determinations across 0.002-32 µg/mL with C. albicans, C. glabrata, C. parapsilosis and C. tropicalis.

Etest is an agar-based gradient technique for quantitative antifungal susceptibility testing of Candida species. It uses a predefined concentration gradient of the specific antifungal agent to determine the Minimum Inhibitory Concentration (MIC) in ug/mL inhibiting the growth of the test organism under defined conditions.

Prescription Use __ ਮ (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)

Leedalie k. Poolr
Division Sign-Off

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ision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K082534