SENSITITRE YEASTONE SUSCEPTIBILITY PLATES

K133038 · Trek Diagnostic Systems · NGZ · Jan 31, 2014 · Microbiology

Device Facts

• Record ID: K133038
• Device Name: SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
• Applicant: Trek Diagnostic Systems
• Product Code: NGZ · Microbiology
• Decision Date: Jan 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Sensititre® YeastOne® Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for Micafungin in the dilution range of 0.008 – 16 µg/ml is intended for testing Candida spp. on the Sensititre® YeastOne® Susceptibility system. The approved primary "Indications for Use" and clinical significance of Micafungin is for: Candida albicans Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis

Device Story

Sensititre YeastOne is a micro-broth dilution susceptibility test for Candida spp. Device uses micro-dilution plates containing serially diluted antifungal agents and a colorimetric growth indicator. Clinical laboratory personnel inoculate plates using autoinoculator or manual methods; plates are sealed and incubated at 35°C for 24 hours. Growth is determined by visual observation of color change (blue to pink) in wells; lowest dilution maintaining no color change indicates Minimum Inhibitory Concentration (MIC). Results assist clinicians in determining antifungal susceptibility profiles to guide therapeutic decisions. Ability to detect Micafungin resistance is currently unknown due to lack of resistant strains; confirmatory testing at reference labs required for non-susceptible results.

Clinical Evidence

Bench testing only. Performance was evaluated by comparing the Sensititre YeastOne system results for Micafungin against a reference method. Testing confirmed the system's ability to provide accurate MIC determinations for the specified Candida species within the claimed dilution range.

Technological Characteristics

Micro-dilution tray format with dried antifungal medium and colorimetric growth indicator (REDOX-based). Manual reading of color change (blue to pink). Inoculation via autoinoculator or manual pipette. Standardized using nephelometer. Complies with CLSI M27-A3 and M27-S4 standards.

Indications for Use

Indicated for in vitro clinical susceptibility testing of Candida spp. (C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis) to the antifungal agent Micafungin in the concentration range of 0.008–16 µg/ml. 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.

Predicate Devices

• VITEK® AST-YS Fluconazole (k061945)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle.

Public Health Service

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

TREK DIAGNOSTIC SYSTEMS CINDY KNAPP DIRECTOR US REGULATORY AND CLINICAL AFFAIRS I THERMO FISHER WAY OAKWOOD VILLAGE OH 44146

January 31, 2014

Re: K133038

Trade/Device Name: Sensititre Yeastone Susceptibility Plates Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: NGZ Dated: January 02, 2014 Received: January 06, 2014

Dear Mrs. Knapp:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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.

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Page 2-Mrs. Knapp

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Uwe Scherf - S for

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): k133038

Device Name: Sensititre® YeastOne® Sysceptibility System with Micafungin (0.008 -16ug/ml) for Candida spp.

Indications for Use: The Sensititre® YeastOne® Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp.

This 510(k) is for Micafungin in the dilution range of 0.008 – 16 µg/ml is intended for testing Candida spp. on the Sensititre® YeastOne® Susceptibility system. The approved primary "Indications for Use" and clinical significance of Micafungin is for:

Candida albicans Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH)