(113 days)
Diagnostic Markers, Inc.'s YeasTest™ Diagnostic Kit is used for the detection of catalase-peroxidase activity in Candida species from vaginal specimens.
Diagnostic Markers, Inc.'s YeasTest™ Diagnostic Kit
The provided text is a letter from the FDA regarding a 510(k) clearance for the "YeasTest™ Diagnostic Kit." This document does not contain any information about acceptance criteria, device performance metrics, study designs (sample sizes, ground truth establishment, expert qualifications, or adjudication methods), or comparative effectiveness studies (MRMC or standalone).
The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulatory classifications, general controls, and compliance. The "Indications For Use" section states that the device is "used for the detection of catalase-peroxidase activity in Candida species from vaginal specimens," but provides no data or performance specifications.
Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance based on the provided input.
§ 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.