# K033864: Genzyme Osom Trichomonas Rapid Test

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Corp.
- Decided: Apr 2, 2004 after 112 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
Longest line of descent: 1 generation back to K020226 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020226: Xenostrip-TV Trichomonas Diagnostic Test Kit; Catalog Numbers S1383.01, S1383.02 & S1383.03, Hellen Professional Services (2002) Summary page 1.

## Indications for use
The OSOM® Trichomonas Rapid Test is intended for the qualitative detection of Trichomonas vaginalis ("Trichomonas") antigens from vaginal swabs and from the saline solution prepared when making wet mounts from vaginal swabs. This test is intended for use in patients with symptoms of vaginosis/vaginitis or suspected exposure to the Trichomonas pathogen. This device is intended for use in physicians' offices as well as clinical laboratories.

Source page: https://510kreport.com/device/K033864
Methodology: https://510kreport.com/methodology