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Intended Use: The CR cartridge is intended for professional use with the IRMA® Blood Analysis System for the direct measurement of creatinine, in human whole blood. The CR cartridge and the IRMA® Blood Analysis System are for in vitro diagnostic use. Indications for Use: The measurement of creatinine aids in the diagnosis and treatment of certain renal diseases, and in monitoring renal dialysis.

The IRMA® SL Blood Analysis System CR Creatinine Cartridge is for use with the IRMA Blood Analysis System. The creatinine cartridge is a single use, disposable cartridge, for the in vitro measurement of creatinine in whole blood. Samples are introduced via syringe or capillary injections with the IRMA® Capillary Collection Device. The creatinine sensor uses an enzymatic method for measuring creatinine. The IRMA sensors are calibrated prior to each test using a calibrant packaged with the sensor. Calibration of the cartridge is completed when information determined at the factory for each lot of cartidges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry. Throughout the calibration and analysis process, signals from the sensors are analyzed. If any abnormal conditions are detected, an error message is generated and the test will be terminated. If there are no abnormal conditions, then the sample results are displayed after successful calibration and analysis. In addition, the user has the option to print a hard copy of the results.

The lactate sensor is intended for professional and point of care use with the IRMA " Blood Analysis System for the direct measurement of lactate, in human whole blood. The Lactate Cartridge and the IRMA "Blood Analysis System are for in vitro diagnostic use. Lactate evaluates the acid-base status and is used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

The IRMA" SL Blood Analysis System Lacrate Cartridge is for use with the IRMA "Blood Analysis System. The Lactate cartridge is a single use, disposable cartridge, for the in vitro measurement of lactate in whole blood. Samples are introduced via syringe or capillary injections with the IRMA® Capillary Collection Device. The lactate sensor uses an amperometric electrode along with a reference electrode that measures the lactate oxidase reaction. The IRMA® sensors are calibrated prior to each test using a calibrant packaged with the sensors. Calibration of the cartidge is completed when information determined at the factory for each lot of cartridges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry. Throughout the calibration and analysis process, signals from the sensors are analyzed. If any abnormal conditions are detected, an error message is generated and the test will be terminated. If there are no abnormal conditions, then the sample results (measured and calculated) are displayed after successful calibration and analysis. In addition, the user has the option to print a hard copy of the results.

The GL Cartridge is intended for professional use with the IRMA® Blood Analysis System for the direct measurement of sodium, potassium, glucose, and chloride in human whole blood. The GL Cartridge and the IRMA® Blood Analysis System are for in vitro diagnostic use. The electrolyte measurements (Nat, K*, Cl ) are used to assess hydrational status, aid in the diagnosis of respiratory and metabolic acid-balance, and prevention of cardiac arrhythmia. Common disease states, which use these measurements for diagnosis, are acid-base disturbances, dehydration, diarrhea, ketoacidosis, alcoholism and other toxicities. The measurement of glucose aids in the diagnosis and treatment of diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia.

The IRMA® SL Blood Analysis System GL Cartridge is for use with the IRMA Blood Analysis System. The GL cartidge is a single use, disposable carridge, for the in vitro measurement of any of the may on the may GL cartidge comprises the analytes sodium, potassium (K945240), chloride (K981270) and glucose. Oiz currently markets cartridges with sodium, potassium, (K945240) and chloride. Samples are introduced via syringe or capillary injections with the IRMA® Capillary Collection Device. The glucose sensor uses an amperometric electrode along with a reference electrode that measures the glucose oxidase reaction. The IRMA® sensors are calibrated prior to each test using a calibrant packaged with the sensors. Calibration of the cartridge is completed when information a canorally partil the factory for each lot of cartridges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry. Throughout the calibration and analysis process, signals from the sensors are analyzed. If any abnormal conditions are detected, an error message is generated and the test will be terminated. If abliotinal continuent a conditions, then the sample results (measured and calculated) are displayed after successful calibration and analysis. In addition, the user has the option to print a hard copy of the results.

The IRMA Blood Analysis System is intended for professional use in those settings where direct measurement of blood such as blood gases (pCO2 and pO2), pH, Na , K , iCa BUN. CI'. and Hct. in whole blood are performed such as the clinical laboratory or the patient bedside. The pH, pCO2, pO2 measurements, and their associated calculated values are used to assess acid-base status and state of oxygenation. Common causes of acid-base disturbances include: cardiopulmonary disease, metabolic abnormalities, drugs and poisons, and fluid imbalance. The electrolyte measurements (Na . K . Cl) are used to assess hydrational status, aid in the diagnosis of respiratory and metabolic acid-balance, and prevention of cardiac arrhythmia. Common disease states which utilize these measurements for diagnosis are acid-base disturbances, dehydration, diarrhea, ketoacidosis, alcoholism and other toxicities. The measurement of ionized calcium is used to assess disease states such as thyroid abnormalities, renal failure or transplant, and to monitor dialysis patients. The measurement of blood urea nitrogen is used to monitor renal disease, dialysis --patients, and hyperalimentation. The measurement of hematocrit is used to assess anemia, blood loss such as in an accident or during surgical procedures, and polycythemia. With the addition of BUN and Cr, the IRMA Blood Analysis System will measure: blood gases (pCO2 and pO2), pH, sodium, potassium, ionized calcium, blood urea nitrogen, chloride, and hematocrit. The sensor arravs of the cartridge will also be packaged in various combinations.

The current IRMA Blood Analysis System comprises a system of an electronic instrument and disposable cartridges (single-use or multi-use) intended for the measurement of blood gases (pCO2 and pO2), pH, potassium, sodium, ionized calcium, and hematocrit in blood. The new system will measure the above mentioned analytes plus blood urea nitrogen (BUN) and chloride (Cl) in blood on the single-use cartridge. Except for the addition of these two analytes and their associated changes, the system will remain the same as the current system. The IRMA analyzer can use either battery or AC power. The system's operation utilizes a microprocessor which is controlled by internal electronics and diagnostics. The microprocessor controls the touch screen, analog electronics which collect the digital signals from the sensors and the controls the printer. The printer provides a hard copy of the measured and calculated values. Samples are introduced via syringe or capillary injections with the IRMA Capillary Collection Device. The minimum sample volumes are 200uL from a syringe injection and 125uL from a Capillary Collection Device injection. Other capillary collection devices which require aspiration are not compatible with the system. The cartridges utilize microelectrode technology for the measurement of the following blood analytes: pH, pCO2, pO2, sodium, potassium, ionized calcium, blood urea nitrogen, chloride, and hematocrit. The principles of measurement are similar to traditional electrode methodologies for blood gas and electrolyte measurements. The pH, pCO2, Na*, K*, iCa**, BUN, and Cli utilize ion-selective potentiometric electrodes including a reference electrode. The pO2 electrode is an amperometric Clark electrode. The hematocrit sensor utilizes a conductivity electrode.

The IRMA Blood Analysis System is intended for professional use in those settings where blood analysis of blood gases (pCO2 and pO2), pH, Na+, K+, iCa++ and Hct in whole blood are performed such as the clinical laboratory or the patient bedside. The system may utilize either a single-use or a multi-use cartridge for these measurements. The pH, pCO2, pO2 measurements, and their associated calculated values are used to assess acid-base status and state of oxygenation. Common causes of acid-base abnormalities, drugs and poisons, and fluid imbalance. The electrolyte measurements (Na+, K+) are used to assess hydrational status, aid in the diagnosis of respiratory and metabolic acid-balance, and prevention of cardiac arrhythmia. Conditions which utilize these measurements for diagnosis are malnutrition, diarrhea, ketoacidosis, alcoholism and other toxicities. The measurement of ionized calcium is used to assess disease states such as thyroid abnormalities, renal failure or transplant, and to monitor dialysis patients. The measurement of hematocrit is used to assess anemia, blood loss such as in an accident or during surgical procedures, and polycythemia. These indications for use of the IRMA Blood Analysis System which utilizes the multiuse cartridge are identical to those of the IRMA Blood Analysis System which utilizes the single-use cartridge. The System will now offer the user an option to choose which cartridge platform best fits their needs either the single-use or multi-use cartridge. Both platforms offer the following sensors: blood gases (pCO2 and pO2), pH, sodium, potassium, ionized calcium, and hematocrit. Similar to the single-use cartridge, the sensor arrays of the multi-use cartridge will also be packaged in various combinations.

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The IRMA® Blood Analysis System is intended for professional use in those settings where direct measurement of blood such as blood gases (pCO2 and pO2), pH, Na+, K+, iCa++ and Hct in whole blood are performed such as the clinical laboratory or patient bedside, and The IRMA/Lifescan SureStep®Pro glucose module is intended for quantitative measurement of glucose in a sample of whole blood. It can be used in a clinical setting to measure glucose in arterial, venous, and capillary samples in both adults and neonates. It can also be used by lay persons for capillary blood glucose monitoring in the home. Indications for Use: The pH, pCO2, pO2 measurements, and their associated calculated values are used to assess acid-base status and state of oxygenation. Common causes of acid-base disturbances include cardiopulmonary disease, metabolic abnormalities, drugs and poisons, and fluid imbalance. The electrolyte measurements (Na+ K+)are used to assess hydrational status, aid in the diagnosis of respiratory and metabolic acid-balance, and prevention of cardiac armythmia. Common disease states which utilize these measurements are acid-base disturbances, dehydration, diarrhea, ketoacidosis, alcoholism and other toxicities. The measurement of ionized calcium is used to assess disease states such as thyroid abnormalities, renal failure or transplant, and to monitor dialysis patients. The measurement of hematocrit is used to assess anemia, blood loss such as in an accident or during surgical procedures, and polycythemia. The measurement of glucose on the module is used to monitor glucose levels in diabetic patients. It is not intended to be used for the diagnosis of diabetes. These indications for use are identical to the predicate devices since the new system consists of an integration of the two predicate devices.

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