# K122062: Aptima Trichomonas Vaginalis Assay - Panther

- Pathway: 510(k) (Traditional)
- Applicant: Gen-Probe, Inc.
- Decided: Jan 9, 2013 after 180 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: 1 generation back to DEN110012 (2011). 1 ancestor in all.
11 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN110012: Aptima Trichomonas Vaginalis Assay, Gen-Probe Incorporated (2011). 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.

## Most influential descendants
- K151565: Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit (2015), 4 descendants of its own
- K200748: Visby Medical Sexual Health (2021), 2 descendants of its own
- K200436: Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit (2020), 2 descendants of its own
- K220407: Visby Medical Sexual Health Test (2023), 1 descendant of its own
- K200866: Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) (2020), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K122062
Methodology: https://510kreport.com/methodology