# DEN110012: Aptima Trichomonas Vaginalis Assay

- Pathway: De Novo (Post-NSE)
- Applicant: Gen-Probe Incorporated
- Decided: Apr 19, 2011 after 6 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
No predicates in its family tree.
20 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K122062: Aptima Trichomonas Vaginalis Assay - Panther (2013), 11 descendants of its own
- K130268: BD Probetec Trichomonas Vaginalis (TV) QX Amplified Dna Assay (2013), 7 descendants of its own
- K151589: BD Max CT/GC/TV, BD Max Instrument (2016), 6 descendants of its own
- 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
- K182692: BD MAX CTGCTV2, BD MAX System (2019), 3 descendants of its own

Source page: https://510kreport.com/device/DEN110012
Methodology: https://510kreport.com/methodology