(363 days)
The Xenotope Diagnostics' Inc. XenoStrip™-Tv Trichomonas Cassette Test is intended for the qualitative detection of Trichomonas vaginalis ("Trichomonas") antigens from vaginal swabs. This test is intended for use in patients with symptoms of vaginosis/vaginitis or suspected exposure to the Trichomonas pathogen.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "XenoStrip-TVTM Trichomonas Cassette Test". It does not contain information about acceptance criteria, study details, or performance data for the device. The letter primarily states that the device has been found substantially equivalent to legally marketed predicate devices and can therefore be marketed.
Therefore, I cannot provide the requested information from this document.
§ 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.