# K020226: Xenostrip-TV Trichomonas Diagnostic Test Kit; Catalog Numbers S1383.01, S1383.02 & S1383.03

- Pathway: 510(k) (Traditional)
- Applicant: Hellen Professional Services
- Decided: Aug 22, 2002 after 212 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K033864: Genzyme Osom Trichomonas Rapid Test (2004), 0 descendants of its own

## Indications for use
The Xenotope Dlsgnostics Inc. XenOStripM- rv Trichomonas Teat is Intended for the qualitative detectlon of Tfichomonas vagfnalls (L'Trlchomonas'3 antigens from vaginal swabs. Early detection and treatment of trichomonas-related diseases (vaginitls, trtchomoniasis) is useful in the prevention and reduction of disease and dkease symptomotogy.

Source page: https://510kreport.com/device/K020226
Methodology: https://510kreport.com/methodology