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510(k) Data Aggregation
K Number
K992140Device Name
PICCOLO METLYTE 7 REAGENT DISC
Manufacturer
ABAXIS, INC.
Date Cleared
1999-08-26
(63 days)
Product Code
JLB, CEM, KHS
Regulation Number
862.1210Why 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
K971817Device Name
OLYMPUS CK-MB REAGENT
Manufacturer
OLYMPUS AMERICA, INC.
Date Cleared
1997-06-11
(26 days)
Product Code
JLB
Regulation Number
862.1210Why 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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