BEUDAMED
    Product Code: OUY FDA class 2 21 CFR 866.3860

    Trichomonas Vaginalis Nucleic Acid Amplification Test System

    Immunology

    The Trichomonas Vaginalis Nucleic Acid Amplification Test System (product code OUY) is an in vitro nucleic acid amplification test for the qualitative detection of ribosomal RNA from Trichomonas vaginalis, used as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital, and gynecological specimens from symptomatic patients. It provides a more sensitive method for detecting this common sexually transmitted parasitic infection compared to microscopy. As an FDA Class 2 device under regulation 866.3860, it requires 510(k) premarket clearance and falls within the Immunology specialty, reviewed by the Microbiology panel. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    10
    FEI Numbers
    14
    Registration Numbers
    14
    Unique Applicants
    7
    Years Active
    13

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    Basic Information

    Product Code
    OUY
    Device Class
    FDA class 2
    Regulation Number
    866.3860
    Medical Specialty
    Immunology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 10 510(k) clearances via K numbers.

    K Number Device Name
    K231316 Aptima Trichomonas vaginalis Assay
    K182692 BD MAX CTGCTV2, BD MAX System
    K151589 BD MAX CT/GC/TV, BD MAX INSTRUMENT
    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
    K161182 Solana Trichomonas Assay
    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
    K143329 AmpliVue Trichomonas Assay
    K130268 BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY
    K122062 APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER
    DEN110012 APTIMA TRICHOMONAS VAGINALIS ASSAY

    FEI Numbers

    This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.