(183 days)
C. albicans/C. glabrata PNA FISH is a fluorescence qualitative nucleic acid hybridization assay intended for identification of C. albicans and/or C. glabrata on smears made from yeast positive blood cultures.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
C. albicans/C. glabrata PNA FISH is indicated for use as an aid in the diagnosis of C. albicans and/or C. glabrata fungemia.
Not Found
The provided text is a 510(k) substantial equivalence letter for a medical device and therefore does not contain details about specific acceptance criteria, study data, or ground truth establishment for an AI/ML powered device. This type of document primarily confirms that a device is substantially equivalent to a previously marketed device and outlines regulatory responsibilities.
To provide the requested information, a clinical study report or a premarket submission summary for an AI/ML device would be necessary. The current document is for a traditional diagnostic assay, not an AI/ML system.
§ 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.