SENSITITRE YEASTONE SUSCEPTIBILITY PLATES

K090968 · Trek Diagnostic Systems, Inc. · NGZ · Jun 4, 2009 · Microbiology

Device Facts

• Record ID: K090968
• Device Name: SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: NGZ · Microbiology
• Decision Date: Jun 4, 2009
• 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 caspofungin in the dilution range of 0.008 - 16ug/ml for testing Candida spp. on the Sensititre® YeastOne® Susceptibility system. The approved primary "Indications for Use" and clinical significance of caspofungin is for: Candida albicans Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis

Device Story

Sensititre® YeastOne® Susceptibility system is a micro-version of broth dilution susceptibility test. Device consists of micro-dilution plates containing serially diluted antifungal agents and a colorimetric growth-indicating compound. After inoculation with yeast isolates, plates are sealed and incubated at 35°C for 24 hours. Growth is determined by colorimetric change in the REDOX state of the test organism, providing a quantitative MIC result. Used in clinical laboratories; manual reading of color change. Output assists clinicians in determining antifungal susceptibility of Candida species to guide therapeutic decisions.

Clinical Evidence

Performance established via method comparison study using 304 clinical and 742 challenge Candida isolates. Compared against CLSI M27 reference method. Combined Essential Agreement (EA) was 97.9% (automated) and 99.8% (manual). Category Agreement (CA) was 100% (automated) and 99.8% (manual). Reproducibility >95% across three sites. No clinical sensitivity/specificity data provided as this is an in vitro diagnostic assay.

Technological Characteristics

Microbroth dilution susceptibility testing system. Uses multi-well plates with dried antimicrobial agents. Principle of operation involves colorimetric detection of fungal growth using an indicator (Alamar Blue). Range: 0.008 - 16ug/ml for caspofungin. System is designed for in vitro diagnostic use.

Indications for Use

Indicated for testing Candida albicans, C. glabrata, C. krusei, C. parapsilosis, and C. tropicalis using caspofungin in the dilution range of 0.008 – 16 µg/mL. Prescription use only. Resistant strains were not available for testing; non-susceptible results require confirmation by alternate method.

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)
• Sensititre YeastOne (k081063)

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 features a stylized depiction of an eagle or bird-like figure with three wing-like shapes extending upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Cythina C. Knapp Director Lab Services Trek Diagnostic System Inc 982 Keynote Circle Suite 6 Cleveland, OH 44131

JUN - 4 2009

Re: k090968

Trade/Device Name: Sensititre® YeastOne® Susceptibility System with Caspofungin (0.008 - 16ug/ml) for Candida spp. Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: NGZ Dated: March 31, 2009 Received: April 6, 2009

### Dear Ms 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.

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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Sally attigim

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):

Device Name: Sensititre® YeastOne® Susceptibility System with Caspofungin (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 caspofungin in the dilution range of 0.008 - 16ug/ml for testing Candida spp. on the Sensititre® YeastOne® Susceptibility system. The approved primary "Indications for Use" and clinical significance of caspofungin 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)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Freddie W. Poole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

109 0968 510(k)

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