(212 days)
The Xenotope Diagnostics Inc. XenoStrip™-Tv Trichomonas Test is Intended for the qualitative detection of Trichomonas vaginalis ("Trichomonas") antigens from vaginal swabs. Early detection and treatment of trichomonas-related diseases (vaginitis, trichomoniasis) is useful in the prevention and reduction of disease and disease symptomology.
Not Found
This is a letter issued by the FDA regarding the 510(k) premarket notification for the "Xenotope Diagnostics Inc. XenoStrip™-Tv Trichomonas Test."
Based on the provided document, the device described is a rapid, qualitative immunoassay for the detection of Trichomonas vaginalis antigens from vaginal swabs. The FDA letter confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided document does not contain any information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This letter is a regulatory approval, not a scientific study report.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details based on the provided text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or the relevant sections from the 510(k) submission itself which would detail the performance studies.
§ 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.