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510(k) Data Aggregation

    K Number
    K972384
    Device Name
    AQ ONE STEP COCAINE TEST
    Manufacturer
    BIONIKE LABORATORIES, INC.
    Date Cleared
    1997-08-06

    (41 days)

    Product Code
    DIO
    Regulation Number
    862.3250
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AQ ONE STEP COCAINE TEST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Bionike One Step Cocaine Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of benzoylecgonine at a cutoff concentration of 300ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals only.

    Device Description

    Not Found

    AI/ML Overview

    This FDA premarket notification (510k) provides marketing authorization for a device and therefore does not contain acceptance criteria or study data.

    To clarify, 510(k)s demonstrate substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. This typically involves performance data compared to the predicate, but not necessarily a formal study with acceptance criteria in the same way a de novo or PMA submission would require.

    Therefore, I am unable to provide the requested information based on the provided document.

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