# K143329: AmpliVue Trichomonas Assay

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corporation
- Decided: Mar 17, 2015 after 117 days
- Product code: OUY (Trichomonas Vaginalis Nucleic Acid Amplification Test System)
- Device class: 2
- Regulation: 21 CFR 866.3860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN110012 (2011). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122062: Aptima Trichomonas Vaginalis Assay - Panther, Gen-Probe, Inc. (2013) Summary page 7.

## Most influential descendants
- K161182: Solana Trichomonas Assay (2016), 0 descendants of its own

## Indications for use
The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis.

Source page: https://510kreport.com/device/K143329
Methodology: https://510kreport.com/methodology