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510(k) Data Aggregation

    K Number
    K963002
    Device Name
    ACTIVE ANDROSTENEDIONE EIA
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    1996-08-16

    (14 days)

    Product Code
    CIZ
    Regulation Number
    862.1075
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    Product Code :

    CIZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DSL. Androstenedione EIA assay is intended for the quantitative determination of androstenedione in human serum. The measurement of androstenedione is used in the diagnosis and treatment of females with excessive levels of androgen production.
    Device Description
    The EIA format is a competitive binding protein assay. Enzyme-labeled androstenedione competes with un-labeled androstenedione in the serum sample for binding sites to the androstenedione antibody coated to the microtitration well provided with the kit. Separation of free from bound androstenedione is achieved by aspirating and washing the wells. The resultant is analyzed in a spectrophotometer for bound absorbance. The amount of enzymelabeled androstenedione bound to the antibody is inversely proportional to the concentration of the androstenedione present in the sample.
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