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510(k) Data Aggregation
K Number
K991834Device Name
CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772
Manufacturer
CHOLESTECH CORP.
Date Cleared
1999-09-09
(104 days)
Product Code
CKD
Regulation Number
862.1030Why did this record match?
Product Code :
CKD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cholestech L·D·X Alanine aminotransferase Test (ALT) is for the in vitro quantitative determination of alanine aminotransferase (ALT) in whole blood or serum on the Cholestech L.D.X Analyzer.
Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
Device Description
The Cholestech L·D·X Alanine Aminotransferase Test (ALT) combines an enzymatic methodology and a solid-phase technology to measure ALT in whole blood or serum. Blood from a fingerstick is collected into a lithium heparin coated capillary tube (venous whole blood serum is also acceptable) and dispensed into a L·D·X cassette. The cassette is then placed into the Cholestech L·D·X where a unique system separates the plasma from the blood cells. The plasma flows to both sides of the cassette and is transferred to the ALT reaction pad.
The Cholestech L•D•X Analyzer measures alanine aminotransferase by an enzymatic method based on the method formulation of Katsuyama et al. Alanine aminotransferase catalyzes the transfer of amino groups from L-Alanine and α-Ketoglutarate to pyruvate and glutamate. Pyruvate oxidase, in the presence of oxygen, oxidizes the pyruvate to acetylphosphate and hydrogen peroxide. In a reaction catalyzed by horseradish peroxidase, the peroxide reacts with an indicator dye to form a blue color at a rate proportional to the ALT concentration of the sample. The resultant color in the reaction is measured by reflectance photometry.
L-Alanine + α -Ketoglutarate Alanine Aminotransferase → Pyruvate + Glutamate
Pyruvate + Phosphate + O2 + H2O Pyruvate Oxidase → Acetylphosphate + CO2 + H2O2
Indicator + H2O2 Peroxidase → Colored Blue Dye + H2O
A brown magnetic stripe on each cassette contains the calibration information required for the Cholestech L•D•X Analyzer to convert the reflectance reading to the ALT concentration in U/L at 37° C.
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