← Product Code [LLH](/submissions/MI/subpart-c%E2%80%94microbiology-devices/LLH) · K030991

# C. DIFF CHEK - 30 (K030991)

_Techlab, Inc. · LLH · Jul 11, 2003 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/LLH/K030991

## Device Facts

- **Applicant:** Techlab, Inc.
- **Product Code:** [LLH](/submissions/MI/subpart-c%E2%80%94microbiology-devices/LLH.md)
- **Decision Date:** Jul 11, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.2660
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Indications for Use

The C. DIFF CHEK™ - 30 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™ - 30 is an enzyme immunoassay (EIA) for the detection of Clostridium difficile glutamate dehydrogenase (GDH) antigen in human fecal specimens. Used in clinical laboratory settings by trained personnel. Input: fecal specimen; Output: qualitative visual or spectrophotometric result indicating presence or absence of GDH antigen. Device serves as a screening tool; results must be interpreted alongside patient history and confirmed with additional toxin-detection assays to diagnose C. difficile disease. Benefits include rapid screening to identify potential C. difficile presence, facilitating subsequent diagnostic workflows.

## Clinical Evidence

Bench testing only. Performance evaluated by comparing results against established culture or toxin-detection methods. Sensitivity and specificity metrics were established to demonstrate equivalence to the predicate device.

## Technological Characteristics

Enzyme immunoassay (EIA) for antigen detection. Manual or automated plate-based format. Requires standard laboratory equipment for incubation and reading (e.g., spectrophotometer).

## Regulatory 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.

## Predicate Devices

- C. DIFF CHEK-60

## Submission Summary (Full Text)

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## Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 1 2003

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

k030991 Re:

Trade/Device Name: C. Diff Check™ - 30 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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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): Ko 30991 Not known

C. DIFF CHEKTM - 30 Device Name:

Indications for Use

The C. DIFF CHEK™ - 30 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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div> <span></span> </div> |
|---------------------------------------|----------------------------|
| OR                                    | Over-The Counter Use       |

(Optional format 1-2-96)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety

| 510(k) | K03 0991 |
|--------|----------|
|--------|----------|

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/LLH/K030991](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/LLH/K030991)

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