YEASTEST

K993554 · Diagnostic Markers, Inc. · JXB · Feb 10, 2000 · Microbiology

Device Facts

• Record ID: K993554
• Device Name: YEASTEST
• Applicant: Diagnostic Markers, Inc.
• Product Code: JXB · Microbiology
• Decision Date: Feb 10, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2660
• Device Class: Class 1

Intended Use

Diagnostic Markers, Inc.'s YeasTest™ Diagnostic Kit is used for the detection of catalase-peroxidase activity in Candida species from vaginal specimens.

Device Story

YeasTest™ Diagnostic Kit is an in vitro diagnostic test used to detect catalase-peroxidase activity in Candida species. The device utilizes vaginal specimens as input. It is intended for use by healthcare professionals in a clinical laboratory setting to aid in the identification of Candida species. The test provides a qualitative result based on enzymatic activity, which assists clinicians in diagnosing yeast infections. The device is a manual diagnostic kit.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic kit for enzymatic detection of catalase-peroxidase activity. Manual test format. No software or electronic components.

Indications for Use

Indicated for the detection of catalase-peroxidase activity in Candida species from vaginal specimens.

Regulatory Classification

Identification

A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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## FEB 1 0 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Diagnostic Markers, Inc. c/o Mr. Greg Holland Holland & Associates 3722 Avenue Sausalito Irvine, California 92606

Re: K993554 Trade Name: YeasTest™ Diagnostic Kit Regulatory Class: I Product Code: JXB Dated: January 12, 2000 Received: January 14, 2000

Dear Mr. Holland:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Holland & Associates

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:Diagnostic Markers, Inc.'s YeasTest™ Diagnostic Kit

Indications For Use:

Diagnostic Markers, Inc.'s YeasTest™ Diagnostic Kit is used for the detection of catalase-peroxidase activity in Candida species from vaginal specimens.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993554

Prescription Use Y (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)