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The Piccolo® Potassium Test System, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of potassium, in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. 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.

The Piccolo® Potassium Test System is a single-use, disposable system used with the Piccolo Xpress® chemistry analyzer for the in vitro quantitative determination of potassium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Piccolo® Potassium Test System 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. Alternatively, the disc may also be used with serum. The Piccolo Xpress® chemistry analyzer (previously cleared under K942782) is a portable clinical chemistry system designed to run only Piccolo test rotors. The instrument interacts with the rotor to move fluid across the sensors and generate quantitative results. Specimens are identified by scanning a barcode or by manually entering the information via the touchscreen. The Piccolo Xpress® chemistry analyzer has slots to accommodate the cartridges discs. The analyzer will determine the configuration of the system by detecting which discs are installed. The Piccolo® Potassium Test System will be used with previously cleared rotor systems in a clinical laboratory setting or point-of-care location.

For in vitro quantitative determination of potassium in human serum. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. For IVD use only. Calibrator: The Diazyme Liquid Stable Enzymatic Potassium Assay Calibrator Kit is intended for use in the calibration of quantitative Diazyme Liquid Stable Enzymatic Potassium Assay Kit (DZ113C). For IVD use only. Controls: The Diazyme Liquid Stable Enzymatic Potassium Assay Control Kit is intended for use as quality controls for the Diazyme Liquid Stable Enzymatic Potassium Assay (DZ113C). For IVD use only.

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Diazyme Potassium Enzymatic Assay Kit in conjunction with Diazyme Potassium Low and High Calibrators, are intended for the quantitative in vitro determination of potassium in serum. Results obtained by this assay are used to monitor fluid and electrolyte balance. Diazyme Potassium Enzymatic Assay has controls for normal serum potassium level and abnormal serum potassium level. These controls are used as reference samples for checking the functionality of the Diazyme Potassium Enzymatic Assay.

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Diazyme Potassium Enzymatic Assay Kit in conjunction with Diazyme Potassium Low and High Calibrators, are intended for the quantitative determination of Potassium (K) in serum.

Potassium is determined spectrophotometrically through a kinetic coupling assay system using potassium dependent urea amidolyase (UAL). NADH generated in a coupling enzymatic reaction reduces a water soluble colorless tetrazolium salt, WST-1 in the presence of an electron mediator, 1-methoxy-5-methyl-phenazinium methyl sulfate (PMS), to form a water soluble formazan dye, which has a maximum absorbance at 450 nm. The corresponding increase of optical density at 450 nm is proportional to the potassium concentration in the serum. Diazyme's Potassium Enzymatic Assay is a two reagent (R1 and R2) based kinetic assay system. The results are obtained in 15 min by measuring absorbance at 450 nm. No off line pretreatment is needed. The assay has a wide measuring range from 2 to 8 mmol/L of serum potassium.