C. DIFF CHEK - 60

K030992 · Techlab, Inc. · LLH · Jul 11, 2003 · Microbiology

Device Facts

• Record ID: K030992
• Device Name: C. DIFF CHEK - 60
• Applicant: Techlab, Inc.
• Product Code: LLH · Microbiology
• Decision Date: Jul 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2660
• Device Class: Class 1

Indications for Use

The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile disease. The test does not distinguish toxigenic from non toxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, the test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history. FOR IN VITRO DIAGNOSTIC USE.

Device Story

C. DIFF CHEK™ - 60 is an enzyme immunoassay (EIA) for in vitro diagnostic use. It detects glutamate dehydrogenase (GDH) antigen in human fecal specimens. The device serves as a screening tool for C. difficile disease. It is intended for use by laboratory professionals. The test does not differentiate between toxigenic and non-toxigenic strains; therefore, it must be used in conjunction with additional tests that detect C. difficile toxins and clinical patient history to aid in diagnosis. The output is a qualitative result indicating the presence or absence of the GDH antigen.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Enzyme immunoassay (EIA) for the detection of glutamate dehydrogenase antigen. In vitro diagnostic device. No software or electronic components.

Indications for Use

Indicated for screening fecal specimens for Clostridium difficile antigen (glutamate dehydrogenase) in patients suspected of having C. difficile disease. Used as an aid in diagnosis in conjunction with toxin-detecting tests and patient history. Does not distinguish between toxigenic and non-toxigenic strains.

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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Public Health Service

JUL 1 1 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

David M. Lverly, Ph.D. Vice-President of Research and Development TECHLAB, Inc. VPI Research Park 1861 Pratt Drive, Suite 1030 Blacksburg, VA 24060-6364

Re: k030992 Trade/Device Name: C. Diff Check 1M - 60 Regulation Number: 21 CFR 866.2660 Regulation Name: Microorganism Differentiation and Identification Device Regulatory Class: Class I Product Code: LLH Dated: June 20, 2003 Received: June 23, 2003

Dear Dr. Lyerly:

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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INTENDED USE 2.

510(k) Number (if known): R030992 Not known

Device Name: C. DIFF CHEKTM - 60

Indications for Use

The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile disease. The test does not distinguish toxigenic from non toxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, the test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history. FOR IN VITRO DIAGNOSTIC USE.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use

(Optional format 1-2-96)

Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K030992