(80 days)
The Triage® C. difficile test is an enzyme immunoassay used for the detection of Clostridium difficile antigen (glutamate dehydrogenase or common antigen) and Toxin A in human fecal specimens. The test will be offered as two singular tests for each protein. This test is used as an aid in the diagnosis of C. difficile associated disease.
The Triage® C. difficile test is an enzyme immunoassay.
The provided document is an FDA 510(k) clearance letter for the Triage® C difficile Panel. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this document does not contain any information regarding acceptance criteria, study details, or performance data for the device.
Therefore, I cannot provide the requested information based on the given text. The letter only acknowledges the device's clearance for marketing.
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MAR 20 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
John F. Bruni, Ph.D. Director, Clinical and Regulatory Affairs Biosite Diagnostics 11030 Roselle Street San Diego, CA 92121
Re: K974881 Trade Name: Triage® C difficile Panel Regulatory Class: I Product Code: MCB Dated: December 29, 1997 Received: December 30, 1997
Dear Dr. Bruni:
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 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 OS 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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" (21 CFR 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely vours.
Steven Autman
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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5 lO(k) Number if known)
Device Name: Triage® C. difficile Panel
Indications for Use:
The Triage® C. difficile test is an enzyme immunoassay used for the detection of Clostridium difficile antigen (glutamate dehydrogenase or common antigen) and Toxin A in human fecal specimens. The test will be offered as two singular tests for each protein. This test is used as an aid in the diagnosis of C. difficile associated disease.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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thon
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K97488)
Prescription Use V
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§ 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.