510(k) · Cleared
ClearedAptima Trichomonas Vaginalis Assay - Panther
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gen-Probe, Inc. · OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System
Cleared on Jan 9, 2013 as substantially equivalent to DEN110012 (Gen-Probe Incorporated, 2011) after a 180-day review. Its family tree reaches back 1 generation to 2011. 11 later devices descend from it.
- Decided
- Jan 9, 2013
- Review
- 180 days
- Class
- Class II
- Product code
- OUY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN110012 (2011). 11 later devices descend from it, 5 citing it directly.
- Root · 1 generation backDEN110012 Aptima Trichomonas Vaginalis AssayGen-Probe Incorporated · 2011
- This deviceK122062 Aptima Trichomonas Vaginalis Assay - PantherGen-Probe, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK151565 Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems…Cepheid · 2015
- Descendant · 2 generations on · 2 of its ownK200748 Visby Medical Sexual HealthVisby Medical · 2021
- Descendant · cites it directly · 2 of its ownK200436 Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay…Hologic, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK220407 Visby Medical Sexual Health TestVisby Medical · 2023
- Descendant · 2 generations on · 1 of its ownK200866 Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris)…Hologic, Inc. · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K151565Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert…Cepheid · 2015 · cites it directly4descendants
- K200748Visby Medical Sexual HealthVisby Medical · 2021 · 2 generations on2descendants
- K200436Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test…Hologic, Inc. · 2020 · cites it directly2descendants
- K220407Visby Medical Sexual Health TestVisby Medical · 2023 · 3 generations on1descendant
- K200866Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)Hologic, Inc. · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN110012 | Aptima Trichomonas Vaginalis Assay | Gen-Probe Incorporated | 2011 | — |
| 0 (this device) | K122062 | Aptima Trichomonas Vaginalis Assay - Panther | Gen-Probe, Inc. | 2013 | — |
| +1 | K151565 | Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx… | Cepheid | 2015 | — |
| +2 | K200748 | Visby Medical Sexual Health | Visby Medical | 2021 | — |
| +1 | K200436 | Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) -… | Hologic, Inc. | 2020 | — |
| +3 | K220407 | Visby Medical Sexual Health Test | Visby Medical | 2023 | — |
| +2 | K200866 | Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) | Hologic, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
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 |
|---|---|---|---|
| * | DEN110012 | Aptima Trichomonas Vaginalis Assay Our reading of the summary gave K102911, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN110012, Aptima Trichomonas Vaginalis Assay (Gen-Probe Incorporated), granted Apr 19, 2011; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2011 |
| † | K111409 | Aptima Combo 2 Assay | 2012 |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151565 | Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert… | 2015 | 4 |
| K200436 | Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test… | 2020 | 2 |
| K143329 | AmpliVue Trichomonas Assay | 2015 | 1 |
| K231316 | Aptima Trichomonas vaginalis Assay | 2023 | 0 |
| K220321 | Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris… | 2022 | 0 |
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?
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. 2013, 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 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 women: clinician-collected endocervical swabs, clinician-collected vaginal swabs, and specimens collected in PreservCyt Solution.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122062: Aptima Trichomonas Vaginalis Assay - Panther.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122062
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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