SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS

K081063 · Trek Diagnostic Systems, Inc. · NGZ · Mar 6, 2009 · Microbiology

Device Facts

• Record ID: K081063
• Device Name: SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: NGZ · Microbiology
• Decision Date: Mar 6, 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 voriconazole in the dilution range of 0.008 - 16μg/ml for testing Candida spp. on the Sensititre® YeastOne® Susceptibility system. The approved primary "Indications for Use" and clinical significance of voriconazole is for: Candida albicans Candida krusei Candida parapsilosis Candida tropicalis

Device Story

Sensititre® YeastOne® Susceptibility system is a micro-version of broth dilution susceptibility test. System uses microdilution plates containing serially diluted antifungal agents and a colorimetric growth-indicating compound. After inoculation with yeast samples, plates are sealed and incubated at 35°C for 24 hours. Growth is determined by colorimetric change indicating REDOX state, rather than turbidity. System is used in clinical laboratories; manual reading of color change is performed by laboratory personnel. Output is quantitative MIC value. Results assist clinicians in determining antifungal susceptibility for Candida species, guiding therapeutic decisions.

Clinical Evidence

No clinical data provided. The submission relies on bench testing to demonstrate performance characteristics for the susceptibility testing of Candida spp. against voriconazole.

Technological Characteristics

Microbroth dilution susceptibility testing system. Consists of multi-well plates containing dehydrated antimicrobial agents (voriconazole). Operates via colorimetric or visual growth detection in liquid media. Standardized for clinical laboratory use.

Indications for Use

Indicated for testing C. albicans, C. krusei, C. parapsilosis, and C. tropicalis. Prescription use only. Alternative procedure required for C. glabrata. Resistance detection for Voriconazole is unknown.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## 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

6. 2009 MAR

Re: k081063

> Trade/Device Name: Sensititire® YeastOne® Susceptibility plates Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: NGZ Dated: February 19, 2009 Received: February 20, 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 yours.

Sally attayma

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): K() 8/063

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

Candida albicans 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)

Lueddie Poole

vision Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K081063