# K161182: Solana Trichomonas Assay

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corporation
- Decided: Aug 15, 2016 after 110 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: 3 generations back to DEN110012 (2011). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143329: AmpliVue Trichomonas Assay, Quidel Corporation (2015) Summary page 7.

## Indications for use
The Solana® Trichomonas Assay is an in vitro diagnostic test, using isothermal amplification technology (helicase-dependent amplification, HDA), for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swabs and female urine specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The Solana® Trichomonas Assay is intended for use only with the Solana® instrument.

Source page: https://510kreport.com/device/K161182
Methodology: https://510kreport.com/methodology