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510(k) Data Aggregation

    K Number
    K991010
    Device Name
    ACP
    Manufacturer
    ABBOTT DIAGNOSTICS MFG., INC.
    Date Cleared
    1999-05-19

    (54 days)

    Product Code
    CKB
    Regulation Number
    862.1020
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBOTT DIAGNOSTICS MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in serum.
    Device Description
    Acid Phosphatase is an in vitro diagnostic assay for the quantitative determination of total and prostatic acid phosphatase in human scrum. The Acid Phosphatase assay is a clinical chemistry assay in which the acid phospliatase in the sample catalyzes the hydrolysis of alpha-naphthylphosphate liberating the alpha-naphthol and phosphate. The alpha-naphthol is then coupled with diazotized 2-amino-5-chlorotoluene (Fast Red TR) to form a diazo dye. The absorbances measured at 412 and 660 nm are directly proportional to the amount of acid phosphatase present in the sample. The addition of I .- Tartrate inhibits prostatic acid phosphatase, but does not inhibit other isocnzymes. The difference between the two protocols (Total Acid Phosphatasc and Non-Prostatic Acid Phosphatase) is the level of prostatic acid phosphatase in the sample.
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