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510(k) Data Aggregation

    K Number
    K992140
    Device Name
    PICCOLO METLYTE 7 REAGENT DISC
    Manufacturer
    ABAXIS, INC.
    Date Cleared
    1999-08-26

    (63 days)

    Product Code
    JLB, CEM, KHS
    Regulation Number
    862.1210
    Why did this record match?
    Product Code :

    JLB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Piccolo MetLyte 7 Reagent Disc, used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of creatine kinase, creatinine, glucose, potassium, total carbon dioxide and urea nitrogen in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Indications for Use: Creatine Kinase The creatine kinase assay is used for the quantitation of creatine kinase in human heparinized whole blood, heparinized plasma, or serum. Measurements of creatine kinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction, progressive muscular dystrophy, dermatomyositis, rhabdomyolysis due to drug ingestion, hyperosmolality, autoimmune disease, delirium tremens, convulsions, Crush syndrome, hypothyroidism, surgery, severe exercise, intramuscular injection, physical inactivity, decreased muscle mass. Creatinine The creatinine assay is used for the quantitation of creatinine in human heparinized whole blood, heparinized plasma, or serum. Creatinine measurements are used in the diagnosis and treatment of renal diseases and monitoring of renal dialysis. Glucose The glucose assay is used for the quantitation of glucose in human heparinized whole blood, heparinized plasma, or serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders, including adult and juvenile diabetes mellitus and hypoglycemia. Potassium The potassium assay is used for the quantitation of potassium in human heparinized whole blood, heparinized plasma, or serum. Potassium measurements are used in the diagnosis and treatment of renal glomerular or tubular disease, adrenocortical insufficiency, diabetic ketoacidosis, excessive intravenous potassium therapy, sepsis, panhypopituitarism, in vitro hemolysis, hyperaldosteronism, malnutrition, hyperinsulinism, metabolic alkalosis and gastrointestinal loss. Total Carbon Dioxide The total carbon dioxide assay is used for the quantitation of total carbon dioxide in human heparinized whole blood, heparinized plasma, or serum. Total carbon dioxide measurements are used in the diagnosis and treatment of primary MetLyte 7 alkalosis and primary respiratory alkalosis and acidosis. Urea Nitrogen The urea nitrogen assay is used for the quantitation of urea nitrogen in human heparinized whole blood, heparinized plasma, or serum. Urea nitrogen measurements are used in the diagnosis and treatment of renal and MetLyte 7 diseases.
    Device Description
    The Piccolo MetLyte 7 Reagent Disc is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternately, the disc may also be used with serum.
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    K Number
    K971817
    Device Name
    OLYMPUS CK-MB REAGENT
    Manufacturer
    OLYMPUS AMERICA, INC.
    Date Cleared
    1997-06-11

    (26 days)

    Product Code
    JLB
    Regulation Number
    862.1210
    Why did this record match?
    Product Code :

    JLB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Olympus Creatine Kinase MB reagent is for the quantitative determination of Creatine Kinase-MB isoenzyme in human serum on Olympus analyzers.
    Device Description
    Not Found
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