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510(k) Data Aggregation
K Number
K171971Device Name
Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer
Manufacturer
Lite-On Technology Corp. H.S.P.B.
Date Cleared
2018-01-25
(209 days)
Product Code
CJE, CDN, CGX, CIT, CKA, JJG
Regulation Number
862.1050Why did this record match?
Applicant Name (Manufacturer) :
Lite-On Technology Corp. H.S.P.B.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Comprehensive Metabolic Panel is intended to be used for the quantitative determination of Alkaline Phosphate (ALP), Alanine Aminotransferase (ALP/GPT), Aspartate Aminotransferase (AST/GOT), Blood Urea Nitrogen (BUN) and Creatinine (CREA) in concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
- Alkaline phosphatase or its isoenzymes measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
- Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
- Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
- Blood urea nitrogen measurements are used in the diagnosis and treatment of certain types of renal and metabolic diseases.
- Creatinine measurements are used in the diagnosis and treatment of renal dialysis, and as a calculation basis for measuring other urine analytes.
The skyla Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use.
The Minicare C300 Clinical Analyzer is an in-vitro diagnostic devices for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use.
Device Description
The skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer (private label) and Comprehensive Metabolic Panel is an automatic chemistry system intended for use in clinical laboratories or point-of-care locations. The system consists of a portable analyzer and single-use disposable reagent panel discs.
The analyzer utilizes precision photometric measurement technology, combined with the use of specific reagent panel disc, to measure the amount of substance in blood. The analyzer measures absorbance change of each reaction well in reagent panel disc and covert it to a concentration value for each analyte included on the panel.
The skyla and Minicare Comprehensive Metabolic Panel reagent disc (which contains the Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Blood Urea Nitrogen and Creatinine test systems) is designed to separate a heparinized venous 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.
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