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510(k) Data Aggregation

    K Number
    K981338
    Device Name
    LD-1
    Date Cleared
    1998-05-18

    (35 days)

    Product Code
    Regulation Number
    862.1445
    Why did this record match?
    Product Code :

    JGF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LD-1 assay is used for the quantitation of LD-1 (one of a group of enzymes with similar biological activity) in serum. Measurement of LD-1 is used in the diagnosis and treatment of cardiac diseases, such as myocardial infarction.
    Device Description
    LD-1 is an in vitro diagnostic assay for the quantitative determination of LD-1 in serum. The LD-1 assay is a clinical chemistry assay and employs sodium perchlorate, a chaotropic agent to selectively denature the LDH isoenzyme teteramers with one or more "M" subunits, removing their enzymatic activity. LD-1 is resistant to this denaturation and is assayed simultaneously. The method for measurement of the LDH activity employs the conversion of lactate to pyruvate by LD-1 with a concomitant reduction of NAD to NADH. The rate of NADH formation, as measured by the rate of absorbance increase at 340 nm, is directly proportional to LD-1 activity in the sample.
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