OUY · Trichomonas Vaginalis Nucleic Acid Amplification Test System
Immunology · 21 CFR 866.3860 · Class 2
Overview
| Product Code | OUY |
|---|---|
| Device Name | Trichomonas Vaginalis Nucleic Acid Amplification Test System |
| Regulation | 21 CFR 866.3860 |
| Device Class | Class 2 |
| Review Panel | Immunology |
Identification
A Trichomonas vaginalis nucleic acid assay is a device that consists of primers, probes, enzymes, and controls for the amplification and detection of trichomonas nucleic acids in endocervical swabs, vaginal swabs, and female urine specimens, from women symptomatic for vaginitis, cervicitis, or urethritis and/or to aid in the diagnosis of trichomoniasis in asymptomatic women. The detection of trichomonas nucleic acids, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of trichomoniasis caused by Trichomonas vaginalis.
Classification Rationale
Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection of Trichomonas vaginalis; Guideline for Industry and Food and Drug Administration Staff.” See § 866.1(e) for information on obtaining this document.
Special Controls
*Classification.* Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection of*Trichomonas vaginalis;* Guideline for Industry and Food and Drug Administration Staff.” See § 866.1(e) for information on obtaining this document.
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231316 | Aptima Trichomonas vaginalis Assay | Hologic, Inc. | Nov 6, 2023 | SESE |
| K182692 | BD MAX CTGCTV2, BD MAX System | Becton, Dickinson and Company | Jan 8, 2019 | SESE |
| K151589 | BD MAX CT/GC/TV, BD MAX INSTRUMENT | Becton, Dickinson and Company | Sep 6, 2016 | SESE |
| K161619 | Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems | Cepheid | Aug 29, 2016 | SESE |
| K161182 | Solana Trichomonas Assay | Quidel Corporation | Aug 15, 2016 | SESE |
| 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 | Cepheid | Oct 16, 2015 | SESE |
| K143329 | AmpliVue Trichomonas Assay | Quidel Corporation | Mar 17, 2015 | SESE |
| K130268 | BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | Aug 23, 2013 | SESE |
| K122062 | APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER | Gen-Probe, Inc. | Jan 9, 2013 | SESE |
| DEN110012 | APTIMA TRICHOMONAS VAGINALIS ASSAY | Gen-Probe Incorporated | Apr 19, 2011 | DENG |
Top Applicants
- Quidel Corporation — 2 clearances
- Cepheid — 2 clearances
- Becton, Dickinson and Company — 2 clearances
- Hologic, Inc. — 1 clearance
- Gen-Probe, Inc. — 1 clearance
