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Intended for the in vitro quantitative measurement of acetaminophen in serum, lithium heparin plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.

The SEKURE Acetaminophen L3K assay is an enzymatic, spectrophotometric assay for the measurement of acetaminophen concentration in serum, lithium heparin plasma and sodium heparin plasma. The assay consists two working reagents, an enzyme reagent and a color reagent. The enzyme reagent contains acyl amidohydrolase, which cleaves the amide bond of the acetaminophen, forming p-aminophenol which then reacts with the 2,5- dimethylphenol (contained the color reagent) in the presence of manganese. The product of that reaction causes increased absorbance at 605 nm which is directly proportional to the acetaminophen concentration in the sample. Testing is performed on open system clinical chemistry analyzers, such as the Hitachi 717 (K872494) in conjunction with a calibrator (510(k) exempt) which is included and controls which are provided separately.

The SEKURE HbA1c assay is used to measure the percent concentration of hemoglobin A1c (NGSP) or the HbA1c fraction mmol/mol (IFCC) in human venous whole blood and hemolysate on the SK500 Clinical Chemistry System. Measurement of HbA 1c is used as an aid in the diagnosis of diabetes mellitus, as an aid in the identification of patients at risk for development of diabetes mellitus, and for the monitoring of long-term blood glucose with diabetes mellitus. For In Vitro Diagnostic Use Only.

The SEKURE HbA1c assay is an enzymatic assay for the measurement of the percent hemoglobin A1c concentration. The assay consists of a pre-treatment hemolyzing buffer solution and two working reagents. Testing is performed on the SK500 K103531in conjunction with calibrators and controls which will be provided separately.