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510(k) Data Aggregation

    K Number
    K102428
    Device Name
    WUNDER TEST
    Manufacturer
    Date Cleared
    2012-04-18

    (601 days)

    Product Code
    Regulation Number
    862.3870
    Why did this record match?
    Applicant Name (Manufacturer) :

    HIEN HELEN NGUYEN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A competitive binding immunoassay used for the qualitative determination of Cannabinoids in human urine. The device is visually read and intended for over the counter single use. The test has a cutoff of 50 ng/mL of Cannabinoids. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
    Device Description
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