BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Aptima Trichomonas vaginalis Assay

    K Number: K231316 · Decision Nov 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    9
    Applicant Total
    116
    Review Days
    182

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Aptima Trichomonas vaginalis Assay
    K Number
    K231316
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3860
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hologic, Inc.
    Date Received
    May 8, 2023
    Decision Date
    November 6, 2023
    Product Code
    OUY
    Advisory Committee
    Immunology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OUY), ordered by most recent decision date.

    BD MAX CTGCTV2, BD MAX System

    FDA 510(k)
    FDA Class 2 ·Immunology

    BD MAX CT/GC/TV, BD MAX INSTRUMENT

    FDA 510(k)
    FDA Class 2 ·Immunology

    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

    FDA 510(k)
    FDA Class 2 ·Immunology

    Solana Trichomonas Assay

    FDA 510(k)
    FDA Class 2 ·Immunology

    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

    FDA 510(k)
    FDA Class 2 ·Immunology

    AmpliVue Trichomonas Assay

    FDA 510(k)
    FDA Class 2 ·Immunology
    View all

    Other Clearances by Hologic, Inc.

    K Number Device Name
    K253634 CoolSeal Generator® (CSL-200-90)
    K251993 Panther Fusion GI Expanded Bacterial Assay
    K243341 Genius AI Detection 2.0
    K243396 Aptima SARS-CoV-2 Assay
    K243935 Aptima CMV Quant Assay
    K243345 Aptima BV Assay; Aptima CV/TV Assay
    K242465 Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
    K240886 Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)
    K233352 Aptima HCV Quant Dx Assay
    K241240 Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
    Search all 116 clearances from Hologic, Inc. →