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The OPTI CCA-TS2 system when used with disposable cassettes containing parameter specific sensors is intended to be used for the measurement of pH, pCO2, pO2, Na *, K , Ca *, Cl , Glucose, BUN (urea), lactate, tHb, and SO2 in samples of whole blood, and pH, Na *, K , C * , Cl , Glucose and BUN (urea) in serum and plasma, in a clinical laboratory setting or point of care locations. Measurements of blood gases (PCO2, PO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances. Lactate (lactic acid) measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood). Total hemoglobin {tHb) measurement is used to determine the hemoglobin content of human blood. Oxygen saturation (SO2) measurement is used to determine the oxygen capacity of the hemoglobin. Potassium (K ) measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Calcium (Ca*) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). Sodium (Na*) measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insibidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst),adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Chloride (Cl`) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Urea nitrogen (an end-product of nitrogen metabolism) measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The OPTI® CCA-TS2 is a modified model of the legally marketed OPTI® CCA-TS analyzer system. The OPTI® CCA-TS2 analyzer system uses the same technology and operating principles to perform the same intended uses as the OPTI® CCA-TS cleared with k993837. Optical fluorescence and reflectance technology is used to perform the parameter measurements outlined in the intended use. The technology is the same as that employed in previous models of OPTI products. The OPTI® CCA-TS2 analyzer is sold separately from disposable cassettes containing sensors that interact with an in-vitro blood or plasma/serum sample aspirated into the cassette by the analyzer system. The disposable cassettes are designed and manufactured by OPTI Medical Systems, Inc. for exclusive use with OPTI Analyzers. The parameters reported by the analyzer system are determined by the sensors contained within each cassette style. Various styles of cassettes are available to report up to six combinations of blood gases, electrolytes and metabolites for each sample aspirated into the cassette. Each cassette style is bar-coded with calibration information determined for each lot of cassettes prior to release.

The OPTI CCA-TS B-Lac cassette is intended to be used for in vitro measurements of pH, PCO2, PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood samples (either arterial or venous) on the OPTI CCA-TS system, in either a clinical setting or point-of-care locations. Measurements of blood gases (PCO2, PO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances. Lactate (lactic acid) measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood). Total hemoglobin measurement is used to determine the hemoglobin content of human blood. Oxygen saturation measurement is used to determine the oxygen capacity of the hemoglobin. The OPTI CCA-TS B-Lac cassette is for prescription use only.

The OPTI CCA-TS system is a portable [4.7 x 14.2 x 9.1 inches, 12 pounds], microprocessor-based instrument using optical fluorescence for the measurement blood gases, electrolytes and enzymes and utilizes a graphical touch screen interface. There is an additional laser based measurement of total hemoglobin (tHb) and SO2 capability available with any cassette that contains a pO₂ sensor. The OPTI CCA-TS system is currently cleared [K993837, K984299, and K974784] for the measurement of pH, PO2, PCO2, Na, K, Ca, Cl, Glucose, BUN (Urea), tHb and SO2, Measurements made on the OPTI CCA-TS system require the use of the OPTI CCA-TS analyzer, a disposable cassette containing fluorescent sensors for the measurement of the analytes (except tHb and SO2) and presentation of the blood sample for measurement of tHb and SO2 by lasers on board the CCA-TS analyzer, and software to calculate measurements from the optical data provided by the analyzer for a blood sample and perform on-board QC tests to safeguard results using known standards. OPTI Medical has designed a lactic acid (lactate) sensor to provide lactate results when a cassette containing the lactate sensor is used with the OPTI CCA-TS analyzer. The B-Lac cassette is a disposable, single use cassette that contains four (4) sensors for in vitro measurements of pH, PCO2, PO2, and Lactate. The B-Lac cassette is sealed in a foil pouch along with a desiccant and is marked with a barcode label that includes a lot identification number, calibration information, and expiration date. The OPTI Critical Care Analyzer (CCA-TS model) hardware is unchanged from the design described in the most recent clearance [K993837] of the device. The capacity to add analytes was part of the design since product inception and electromagnetic compatibility is unaffected. Software changes were made to add the lactate measurement algorithms and operational features for the B-Lac cassette addition.