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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.

The Piccolo® Lactate Test System (presently contained on the MetLac 12 Panel Reagent Disc) used with the Piccolo xpress™ Chemistry Analyzer is intended to be used for the in vitro quantitative determination of lactate concentration in heparinized whole blood or heparinized plasma in a clinical laboratory setting or point-of-care location. Lactate measurements are used in the diagnosis and treatment of lactate acidosis, monitoring tissue hypoxia, and diagnosis of hyperlactatemia.

The Piccolo MetLac 12 Panel Reagent Disc (which contains the Piccolo Lactate Test System) is designed for lithium heparinized whole blood and lithium heparinized plasma. The disc meters the required quantity of sample and diluent, mixes the sample with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted sample mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.

The Piccolo Total Cholesterol - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of total cholesterol in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein disorders.

The Piccolo® Lipid Panel - Capillary Reagent Disc (which contains the Piccolo® Total Cholesterol - Capillary 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.

The Piccolo HDL - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of HDL in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The Piccolo® Lipid Panel – Capillary Reagent Disc (which contains the Piccolo® HDL - Capillary 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.

The Piccolo Triglycerides - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of triglycerides in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders.

The Piccolo® Lipid Panel - Capillary Reagent Disc (which contains the Piccolo® Triglycerides - Capillary 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.

The Piccolo® C-Reactive Protein Test System used with the Piccolo xpress™ Chemistry Analyzer is intended to be used for the in vitro quantitative determination of CRP concentration in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point of care location. This test is not intended for high sensitivity CRP measurement. C-Reactive Protein test results aid in the evaluation of infection, tissue injury, and inflammatory disorders in conjunction with other laboratory and clinical findings.

The Piccolo MetLyte Plus CRP Reagent Disc (which contains the Piccolo C-Reactive Protein Test System) is designed for lithium heparinized whole blood, lithium heparinized plasma, and serum, only. The disc meters the required quantity of sample and diluent, mixes the sample with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted sample mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.

The Piccolo Magnesium Test System used with the Piccolo Chemistry Analyzer is intended to be used for the in vitro quantitative determination of magnesium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia.

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The Piccolo Lactate Dehydrogenase Test System (presently contained on the Piccolo Basic Metabolic Panel Plus Reagent Disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of lactate dehydrogenase activity in heparinized plasma or serum in a clinical laboratory setting or point-of-care location. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis and cirrhosis; cardiac diseases such as myocardial infarction; malignant diseases; and tissue alterations of the heart, kidney, liver, and muscle.

The Piccolo Basic Metabolic Panel Plus Reagent Disc (which contains the Piccolo Lactate Dehydrogenase Test System) is designed for heparinized plasma and serum, only. The disc meters the required quantity of sample and diluent, mixes the sample with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted samples mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternately, the disc may also be used with serum.

The Piccolo Magnesium Test System (presently contained on the Renal Function Panel Plus Reagent Disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of magnesium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia.

The Piccolo Renal Function Panel Plus Reagent Disc (which contains the Piccolo Magnesium 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. Alternately, the disc may also be used with serum.

The Piccolo Triglycerides Test System used with the Piccolo Point-of-Care Chemistry Analyzer is intended for the in vitro quantitative determination of triglycerides in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders.

The Piccolo® Lipid Panel Reagent Disc (which contains the Piccolo® Triglycerides 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 analvzer. Alternately, the disc mav also be used with serum.