Search Results

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.

The C. DIFF CHEK™ - 60 test is an enzyme immunoassay.

The provided document does not contain information regarding a study that proves the device meets acceptance criteria, nor does it detail acceptance criteria or device performance data. This document is a 510(k) substantial equivalence letter from the FDA for the C. Diff Check 1M - 60 device, indicating that the device has been found substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document focuses on the regulatory approval of the device based on substantial equivalence, not on a detailed performance study with acceptance criteria.

Ask a specific question about this device