# K020595: Xenostrip-TV Trichomonas Cassette Test, Model C1383.01

- Pathway: 510(k) (Traditional)
- Applicant: Xenotope Diagnostics, Inc.
- Decided: Feb 20, 2003 after 363 days
- Product code: JWZ (Kit, Screening, Trichomonas)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Xenotope Diagnostics’ Inc. XenoStripTM-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.

Source page: https://510kreport.com/device/K020595
Methodology: https://510kreport.com/methodology