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OUY — Trichomonas Vaginalis Nucleic Acid Amplification Test System Class II

FDA Device Classification

Classification Details

Product Code
OUY
Device Class
Class II
Regulation Number
866.3860
Submission Type
Review Panel
MI
Medical Specialty
Immunology
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K231316hologicAptima Trichomonas vaginalis AssayNovember 6, 2023
K182692becton, dickinson andBD MAX CTGCTV2, BD MAX SystemJanuary 8, 2019
K151589becton, dickinson andBD MAX CT/GC/TV, BD MAX INSTRUMENTSeptember 6, 2016
K161619cepheidXpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-IIAugust 29, 2016
K161182quidel corporationSolana Trichomonas AssayAugust 15, 2016
K151565cepheidXpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXOctober 16, 2015
K143329quidel corporationAmpliVue Trichomonas AssayMarch 17, 2015
K130268becton, dickinson andBD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAYAugust 23, 2013
K122062gen-probeAPTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHERJanuary 9, 2013
DEN110012gen-probe incorporatedAPTIMA TRICHOMONAS VAGINALIS ASSAYApril 19, 2011