(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.
§ 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.