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510(k) Data Aggregation

    K Number
    K990957
    Device Name
    ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K
    Manufacturer
    ASTORIA-PACIFIC,INC.
    Date Cleared
    1999-05-11

    (50 days)

    Product Code
    JBL
    Regulation Number
    864.7360
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    Product Code :

    JBL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Astoria-Pacific SPOTCHECK G6PD 50 Hour Reagent Kit is intended for the semi-quantitative determination of glucose-6-phosphate dehydrogenase activity in erythrocytes using the Astoria-Pacific SPOTCHECK Analyzer. Measurements of glucose-6-phosphate dehydrogenase activity are used primarily in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a G6PD deficiency. It is for in vitro diagnostic use primarily as an aid in screening for decreased levels of G6PD enzyme activity. This device is for use by trained, qualified laboratory personnel.
    Device Description
    The Astoria-Pacific SPOTCHECK G6PD 50 Hour Reagent Kit is a reagent kit used for the semi-quantitative determination of glucose-6-phosphate dehydrogenase activity in erythrocytes. The method is based on the spectrophotometric method where enzyme activity is measured by observing NADP+ reduction to NADPH when glucose-6-phosphate is present as a substrate. Maleimide is added to inhibit the production of NADPH by 6-phosphogluconate dehydrogenase. The fluorescent NADPH produced is proportional to the G6PD enzyme activity. The kit contains Extraction Buffer, Tris Buffer, G6PD Substrate, and NADH Stock Std reagents.
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