# OUY: Trichomonas Vaginalis Nucleic Acid Amplification Test System

- Device class: 2; regulation: 21 CFR 866.3860; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 182 days (middle half 182–182)
- Recalls: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2011: 1
- 2013: 2
- 2015: 2
- 2016: 3
- 2019: 1
- 2023: 1

## Most-cited predicates
- K122062: Aptima Trichomonas Vaginalis Assay - Panther (2013), cited by 5
- DEN110012: Aptima Trichomonas Vaginalis Assay (2011), cited by 4
- K182692: BD MAX CTGCTV2, BD MAX System (2019), cited by 2
- 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), cited by 2
- K151589: BD Max CT/GC/TV, BD Max Instrument (2016), cited by 2
- K143329: AmpliVue Trichomonas Assay (2015), cited by 1
- K130268: BD Probetec Trichomonas Vaginalis (TV) QX Amplified Dna Assay (2013), cited by 1

Source page: https://510kreport.com/product-code/OUY
Data by year (CSV): https://510kreport.com/product-code/OUY.csv