(105 days)
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.
Not Found
This document is a 510(k) clearance letter for the C. Diff Check™ - 30 device. It states that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria, study details, or performance data for the device.
Therefore, I cannot provide the requested information. The provided text is a regulatory clearance document, not a clinical study report or performance evaluation.
§ 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.