(113 days)
Diagnostic Markers, Inc.'s YeasTest™ Diagnostic Kit is used for the detection of catalase-peroxidase activity in Candida species from vaginal specimens.
Diagnostic Markers, Inc.'s YeasTest™ Diagnostic Kit
The provided text is a letter from the FDA regarding a 510(k) clearance for the "YeasTest™ Diagnostic Kit." This document does not contain any information about acceptance criteria, device performance metrics, study designs (sample sizes, ground truth establishment, expert qualifications, or adjudication methods), or comparative effectiveness studies (MRMC or standalone).
The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulatory classifications, general controls, and compliance. The "Indications For Use" section states that the device is "used for the detection of catalase-peroxidase activity in Candida species from vaginal specimens," but provides no data or performance specifications.
Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance based on the provided input.
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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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANQTHER PAGE IF NEEDED)
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)
§ 866.2660 Microorganism differentiation and identification device.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.