(123 days)
The VIDAS C. difficile Toxin A II assay detects the presence of C. difficile toxin A. It is substantially equivalent to the Meridian Premier C. difficile Toxin A test as an aid in the diagnosis of Clostridium difficile associated disease (CDAD).
The VIDAS C. difficile Toxin A II assay detects the presence of C. difficile toxin A.
Here's a breakdown of the acceptance criteria and study information for the VIDAS C. difficile Toxin A II assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implied/Expected) | Reported Device Performance |
|---|---|---|---|
| False Positive Results | Specificity | High (e.g., >95%) | 99.1% |
| False Negative Results | Sensitivity | High (e.g., >90%) | 94.9% |
| Equivocal Results | Occurrence | Low (e.g., |
§ 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.