FDA Product Code OUY: Trichomonas Vaginalis Nucleic Acid Amplification Test System
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
Leading manufacturers include Quidel Corporation, Cepheid and Becton, Dickinson and Company.
10
Total
9
Cleared
156d
Avg days
2011
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Trichomonas Vaginalis Nucleic Acid Amplification Test System Devices (Product Code OUY)
10 devices
Cleared
Nov 06, 2023
Aptima Trichomonas vaginalis Assay
Hologic, Inc.
Microbiology
182d
Cleared
Jan 08, 2019
BD MAX CTGCTV2, BD MAX System
Becton, Dickinson and Company
Microbiology
103d
Cleared
Sep 06, 2016
BD MAX CT/GC/TV, BD MAX INSTRUMENT
Becton, Dickinson and Company
Microbiology
452d
Cleared
Aug 29, 2016
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
Microbiology
77d
Cleared
Aug 15, 2016
Solana Trichomonas Assay
Quidel Corporation
Microbiology
110d
Cleared
Oct 16, 2015
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
Microbiology
128d
Cleared
Mar 17, 2015
AmpliVue Trichomonas Assay
Quidel Corporation
Microbiology
117d
Cleared
Aug 23, 2013
BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY
Becton, Dickinson & CO
Microbiology
200d
Cleared
Jan 09, 2013
APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER
Gen-Probe, Inc.
Microbiology
180d
About Product Code OUY - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code OUY since 2011, with 9 receiving FDA clearance (average review time: 156 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.