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510(k) Data Aggregation
K Number
K082001Device Name
DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B
Manufacturer
DIAZYME LABORATORIES
Date Cleared
2008-12-05
(144 days)
Product Code
JII
Regulation Number
862.3560Why did this record match?
Product Code :
JII
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diazyme Liquid Enzymatic Assay Kit is for quantitative in vitro determination of Lithium in human serum. Measurements of Lithium are carried out essentially to ensure that proper drug dosage is administered in the treatment of patient suffering from bipolar disorder and to avoid toxicity.
Device Description
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K Number
K033360Device Name
DIAZYME LITHIUM ENZYMATIC ASSAY KIT
Manufacturer
GENERAL ATOMICS
Date Cleared
2003-12-23
(63 days)
Product Code
JII
Regulation Number
862.3560Why did this record match?
Product Code :
JII
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diazyme Lithium Enzymatic Assay Kit is for quantitative in vitro determination of lithium in human serum and plasma. Measurements of lithium are carried out essentially to ensure that proper drug dosage is administered in the treatment of patient suffering from bipolar disorder and to avoid toxicity.
Device Description
Diazyme's lithium enzymatic assay is a spectrophotometric method, which can be adapted to most automated clinical chemistry analyzers. In Diazyme's lithium enzymatic assay, Lithium is determined spectrophotometrically through a kinetic coupling assay system involving a Diazyme's proprietary phosphatase whose activity is sensitive to lithium concentration (IC50=0.1mM). Through enzymatic coupling, the phosphatase substrate, adenosine biphosphate (PAP) is converted to hypoxanthine by a series of enzymatic reactions to generate uric acid and hydrogen peroxide (H2O2). H2O2 generated reacts with N-Ethyl-N-(2-hydroxy-3-sulfopropyl)-3-m-toluidine (EHSPT) and 4-aminoantipyrine (4-AA) in the presence of peroxidase (POD) to form a quinone dye which has maximal absorbance at 556nm. The rate of the quinine dye formation is inversely proportion to the concentration of lithium in serum samples.
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