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The epoc® Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous, or capillary whole blood in the laboratory or at the point of care. The Blood Gas Electrolyte and Metabolite (BGEM) Test Card panel configuration includes sensors that quantitate pH, pCO2, oO2, Sodium, Potassium, Ionized Calcium, Chloride, Total Carbon Dioxide, Glucose, Lactate, Blood Urea Nitrogen, Creatinine, and Hematocrit. pH, pCO2, pO2 (blood gases) measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of lifethreatening acid-base disturbances. Sodium and Potassium measurements from the epoc Blood Analysis System are treatment of diseases involving electrolyte imbalance. lonized Calcium measurements from the epoc Blood Analysis System are treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. Chloride measurements from the epoc Blood Analysis System are used in the treatment of electrolyte and metabolic disorders. Total Carbon Dioxide measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of disorders associated with changes in body acid-base balance. Glucose measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of carbolism disorders, including diabetes mellitus and idiopathic hypodycemia, and of pancreatic islet cell tumors. Lactate measurements from the epoc Blood Analysis System are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood), Blood Urea Nitrogen measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal and metabolic diseases. Creatinine measurements from the epoc Blood Analysis System are used in the diagnosis and treatment diseases and in monitoring renal dialysis. Hematocrit measurements from the epoc Blood Analysis System are used to distinguish normal states of blood volume, such as anemia and erythrocytosis.

The epoc® Blood Analysis System is an in vitro diagnostic device system for the quantitative testing of blood gases, electrolytes, and metabolites in venous, arterial, and capillary whole blood samples. The epoc® System is comprised of three (3) major subsystems: epoc® Host, epoc® Reader and epoc® BGEM Test Card. - epoc® Blood Gas Electrolyte Metabolite (BGEM) Test Card: single-use, device with . port for blood sample introduction which contains the sensor configurations for testing Sodium (Na+), Potassium (K+), Calcium (Ca++), Chloride (C)I-, pH, partial pressure of carbon dioxide (pCO2), partial pressure of oxygen (pO2), Glucose (Glu), Lactate (Lact), Creatinine (Crea), Hematocrit (Hct), Blood Urea Nitrogen (BUN) and Total Carbon Dioxide (TCO2). - . epoc® Reader: portable, battery-powered device component that measures electrical signals from the test card sensors during blood testing and transmits this sensor data wirelessly via Bluetooth to the epoc Host. - . epoc® Host: mobile computer-based device component for calculating test results from the sensor data sent by the epoc Reader and displaying these results on the graphical user interface. The epoc Host component can be physically connected to the Reader by a cradle component. The epoc Host also incorporates an internal laser barcode scanner for scanning patient and operator IDs. The epoc Host component currently runs on Microsoft® Windows Mobile 6.5 Operating System (OS).

The Blood Urea Nitrogen and Total Carbon Dioxide tests, as part of the epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care. Blood Urea Nitrogen measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal and metabolic diseases. Total Carbon Dioxide measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of disorders associated with changes in body acid-base balance.

The epoc Blood Analysis System is an in vitro diagnostic device system for the quantitative testing of blood gases, electrolytes, and metabolites in venous, arterial, and capillary whole blood samples. The epoc System is comprised of 3 major subsystems: epoc Host, epoc Reader and epoc BGEM Test Card. The main accessory used with the epoc System includes the epoc Care-Fill Capillary Tubes used to collect and introduce capillary blood samples into the epoc Test Card. The epoc Blood Analysis System was previously cleared for prescription use to quantitate pH, pCO2, pO2, Na, K, iCa, Cl, Glu, Lact, Crea, and Hct in arterial, venous, and capillary blood samples per k061597, k090109, k092849, k093297, and k113726. This premarket notification submission adds blood urea nitrogen (BUN) and total carbon dioxide (TCO2) quantitation to the epoc BGEM Test Card and Blood Analysis System.