Trichomonas Vaginalis Nucleic Acid Amplification Test System
FDA product code OUY · Class II (moderate risk) · 21 CFR 866.3860 · Immunology
In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic patients
9510(k) clearances
0PMA approvals
4recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231316 | Aptima Trichomonas vaginalis AssayOUY · Traditional | Hologic, Inc. | 11/06/2023SE |
| K182692 | BD MAX CTGCTV2, BD MAX SystemOUY · Traditional | Becton, Dickinson and Company | 01/08/2019SE |
| K151589 | BD Max Ct/Gc/Tv, BD Max InstrumentOUY · Traditional | Becton, Dickinson and Company | 09/06/2016SE |
| K161619 | Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV…OUY · Traditional | Cepheid | 08/29/2016SE |
| K161182 | Solana Trichomonas AssayOUY · Traditional | Quidel Corporation | 08/15/2016SE |
| K151565 | Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert…OUY · Traditional | Cepheid | 10/16/2015SE |
| K143329 | AmpliVue Trichomonas AssayOUY · Traditional | Quidel Corporation | 03/17/2015SE |
| K130268 | BD Probetec Trichomonas Vaginalis (TV) QX Amplified DNA AssayOUY · Traditional | Becton, Dickinson & CO | 08/23/2013SE |
| K122062 | Aptima Trichomonas Vaginalis Assay - PantherOUY · Traditional | Gen-Probe, Inc. | 01/09/2013SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0818-2026 Class II | 8 in 1 STI Test KitDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0817-2026 Class II | 3 in 1 STI TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0816-2026 Class II | 2 in 1 Trichomonas / Gardnerella TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-2331-2019 Class II | Kit BD Max CT/GC/TV; Catalog # 442970The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | Becton Dickinson & Co. | 07/17/2019Terminated |