510(k) · Cleared
ClearedAptima Trichomonas vaginalis Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System
Cleared on Nov 6, 2023 as substantially equivalent to K122062 (Gen-Probe, Inc., 2013) after a 182-day review. Its family tree reaches back 2 generations to 2011.
- Decided
- Nov 6, 2023
- Review
- 182 days
- Class
- Class II
- Product code
- OUY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN110012 (2011). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K122062 | Aptima Trichomonas Vaginalis Assay - PantherSummary page 5…aginalis Nucleic Acid Amplification Test System Regulation Number: 866.3860 Regulatory Class: Class II Product Code: OUY Legally Marketed Predicate Devices Predicate #: K122062 Predicate Trade Name: Aptima Trichomonas vaginalis Assay Product Code: OUY Device Description Summary Clearance of this pre-mark… | 2013 |
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 12 years and passes through 3 companies; a new generation was cleared every 10.8 years on median.
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K122062.
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. 2023, 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 Aptima Trichomonas vaginalis (TV) assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Panther system.
The assay may be used to test the following specimens from symptomatic or asymptomatic individuals: clinician-collected endocervical swabs, clinician-collected and patient-collected vaginal swabs (in a clinical setting), female and male urine, and specimens collected in PreservCyt Solution.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231316: Aptima Trichomonas vaginalis Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231316
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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