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510(k) Data Aggregation

    K Number
    K961490
    Device Name
    ELECSYS T4 ASSAY
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Date Cleared
    1996-06-13

    (56 days)

    Product Code
    CDX
    Regulation Number
    862.1700
    Why did this record match?
    Product Code :

    CDX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Immunoassay for the in vitro quantitative determination of total thyroxine in human serum and plasma.
    Device Description
    The Elecsys® test principle is based on competition principle. Total duration of assay: 18 minutes (37°C). • 1st incubation (9 minutes): Sample (15 µL) and a specific anti-T4 antibody labeled with a ruthenium complex (75 uL). • 2nd incubation (9 minutes): After addition of biotinylated T4 (75 uL) and streptavidin-coated microparticles (35 uL), the still-free binding sites of the labeled antibody become occupied, with formation of an antibody-hapten complex. The entire complex is bound to the solid phase via interaction of biotin and streptavidin. •The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame). •Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.
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