510(k) · Cleared
ClearedSolana Trichomonas Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corporation · OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System
Cleared on Aug 15, 2016 as substantially equivalent to K143329 (Quidel Corporation, 2015) after a 110-day review. Its family tree reaches back 3 generations to 2011.
- Decided
- Aug 15, 2016
- Review
- 110 days
- Class
- Class II
- Product code
- OUY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN110012 (2011). No later device cites it as a predicate yet.
- Root · 3 generations backDEN110012 Aptima Trichomonas Vaginalis AssayGen-Probe Incorporated · 2011
- 2 generations backK122062 Aptima Trichomonas Vaginalis Assay - PantherGen-Probe, Inc. · 2013
- 1 generation backK143329 AmpliVue Trichomonas AssayQuidel Corporation · 2015
- This deviceK161182 Solana Trichomonas AssayQuidel Corporation · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN110012 | Aptima Trichomonas Vaginalis Assay | Gen-Probe Incorporated | 2011 | — |
| −2 | K122062 | Aptima Trichomonas Vaginalis Assay - Panther | Gen-Probe, Inc. | 2013 | — |
| −1 | K143329 | AmpliVue Trichomonas Assay | Quidel Corporation | 2015 | — |
| 0 (this device) | K161182 | Solana Trichomonas Assay | Quidel Corporation | 2016 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OUY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OUY device
- #1 K231316 Aptima Trichomonas vaginalis Assayscore 6.6 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K143329 | AmpliVue Trichomonas AssaySummary page 7…• Solana Instrument J. Substantial Equivalence Information: 1. Predicate device name(s): AmpliVue® Trichomonas Assay 2. Predicate 510(k) number(s): K143329 3. Comparison with predicate: Similarities Item Sola… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All OUY devicesOUY Trichomonas Vaginalis Nucleic Acid Amplification Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OUY
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OUY
110in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OUY
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OUY
1in 2024
MAUDE reports naming product code OUY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 3 | 110 | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 3 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161182: Solana Trichomonas Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161182
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026