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The S TEST Reagent Cartridge Alanine Amino Transferase (ALT) is intended for the quantitative measurement of the activity of the enzyme alanine amino transferase (ALT) in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. ALT measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. The S TEST Reagent Cartridge Aspartate Amino Transferase (AST) is intended for the quantitative measurement of the activity of the enzyme aspartate amino transferase (AST) in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. AST measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available. The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) × 28 mm (D) × 20.2 mm (H). System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for reagent cartridge test systems for glucose.

The ACE ALT Reagent is intended for the quantitative determination of alanine aminotransferase activity in serum using the ACE Axcel Clinical Chemistry System. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE AST Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum using the ACE Axcel Clinical Chemistry System. Measurements of aspartate aminotransferase are used in the diagnosis and treatment of certain types of liver and heart disease. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE γ-GT Reagent is intended for the quantitative determination of gamma-glutamyltransferase activity in serum using the ACE Axcel Clinical Chemistry System. Gamma-glutamyltransferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

In the ACE ALT Reagent assay, alanine aminotransferase in serum converts the L-alanine and α-ketoglutarate substrates in the reagent to L-glutamate and pyruvate. Lactate dehydrogenase (LDH) catalyzes the oxidation of the reduced cofactor to the cofactor. The rate of conversion of the reduced cofactor to the cofactor can be determined by monitoring the decrease in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from the reduced cofactor to the cofactor is a function of the activity of ALT in the sample. In the ACE AST Reagent assay, aspartate aminotransferase in serum converts the L-aspartate and α-ketoglutarate in the reagent to oxalacetate and L-glutamate. The oxalacetate undergoes reduction with simultaneous oxidation of NADH to NAD+ in the malate dehydrogenase catalyzed indicator reaction. NADH absorbs strongly at 340 nm, whereas NAD+ does not. Therefore, the rate of conversion of NADH to NAD+ can be determined by monitoring the decrease in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from NADH to NAD+ is a function of the activity of AST in the sample. Lactate dehydrogenase is added to prevent interference from endogenous pyruvate, which is normally present in serum. In the ACE γ-GT Reagent assay, γ-GT in serum catalyzes the transfer of the γ-glutamyl group from L-γ-glutamyl-3-carboxy-4-nitroanilide to glycylglycine in the reagent. The product, 5-amino-2-nitrobenzoate, absorbs strongly at 408 nm. The rate of increase in absorbance, monitored bichromatically at 408 nm/486 nm, is directly proportional to the γ-GT activity in the sample.

Dimension Vista™ Albumin (ALB) Flex® reagent cartridge: The ALB method is an in vitro diagnostic test for the quantitative measurement of albumin in human serum and plasma on the Dimension Vista™ System. Measurements obtained by this device are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. Dimension Vista™ Aspartate amino transferase (AST) Flex® reagent cartridge: The AST method is an in vitro diagnostic test for the quantitative measurement of aspartate aminotransferase in human serum and plasma on the Dimension Vista™ System. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. Dimension Vista™ Carbamazepine (CRBM) Flex® reagent cartridge: The CRBM method is an in vitro diagnostic test for the quantitative measurement of carbamazepine in human serum and plasma on the Dimension Vista™ System. Carbamazepine measurements may be used in the diagnosis and treatment of carbamazepine overdose and in therapeutic drug monitoring. Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to ensure appropriate therapy. Dimension Vista™ Alanine amino transferase (ALT) Flex® reagent cartridge: The ALT method is an in vitro diagnostic test for the quantitative measurement of alanine aminotransferase in human serum and plasma on the Dimension Vista™ System. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g. viral hepatitis and cirrhosis) and heart diseases. Dimension Vista™ Total Iron-binding capacity (TIBC) Flex® reagent cartridge: The TIBC method is an in vitro diagnostic test for the quantitative measurement of total iron binding capacity in human serum and plasma on the Dimension Vista™ System. Measurements of total iron binding capacity are used in the diagnosis and treatment of iron deficiency anemia and chronic inflammatory disorders.

Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K 051087). This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system. The ALB, AST, CRBM, ALT, and TIBC reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the devices.

For in vitro diagnostic use with the CARESIDE Analyzer to quantitatively measure ALT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of patients with certain types of liver and heart disease.

CARESIDE ALT cartridges are used with the CARESIDE, Inc. CARESIDE Analyzer to measure ALT activity in anti-coagulated whole blood, plasma, or serum specimens. The CARESIDE® ALT cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of sample to a dry film to initiate the measurement of ALT activity. The patented film cartridge contains all reagents necessary to measure ALT activity. Each CARESIDE ALT cartridge consists of an ALT-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the specimen into the cartridge sample well, closes the lid and inserts the cartridge into the CARESIDE Analyzer. Once loaded, the CARESIDE Analyzer scans the cartridge barcode, brings the cartridge and the contained specimen to 37℃, and spins the cartridge to move the sample from the sample well into the cartridge channels and chambers. Approximately 8.5 microliters of sample remains in the metering passage. Any excess sample flows into an overflow well. The sample is automatically dispensed onto the multi-layer reagent film. The spreading and substrate layer uniformly distributes the specimen. As the specimen passes through the spreading and substrate layer, ALT in the specimen catalyzes the reaction of L-aspartate and a-ketotglutaric acid to form pyruvic acid and L-glutamic acid (see Test Reaction Sequence). The pyruvic acid is converted to acetyl phosphoric acid, CO2 and hydrogen peroxide in the reaction layer. Peroxidase in the reaction layer then catalyzes the oxidation of a diaryliminidazole leuco dye by hydrogen peroxide to form a green dye. The rate of change of intensity of the color as measured by the amount of reflected light at 655 directly relates to the amount of ALT activity in the specimen.

Intended for the In Vitro, quantitative determination of ALT (GPT) activity in human serum on automated chemistry analyzers. "Alanine amino transferase (ALT/SGPT) measurements are used in the diagnosis and treatment of certain types of liver (e.g. viral hepatitis and cirrhosis) and heart diseases." CFR 862.1030

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Intended for the the In Vitro, quantitative determination of ALT (L-Alanine;2-Oxoglutarate Aminotransferase EC2.6.1.2) in human serum on the Cobas MIRA® clinical chemistry system. This alanine aminotransferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine aminotransferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g. viral hepatitus and cirrhosis) and heart diseases. CFR 862.1030 Intended for the the In Vitro, quantitative determination of KAMYLASE (1,4-%- D glucan glucanohydrolase EC3.2.1.1) in human serum and urine on the Cobas MIRA ® clinical chemistry system. This Amylase test system is a device intended to measure the activity of the enzyme Amylase in serum and urine . Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas) CFR 862.1070 Intended for the the In Vitro, quantitative determination of AST (Aspartate aminotransferase EC2.6.1.1) in human serum on the Cobas MIRA ® clinical chemistry system. This "aspartate aminotransferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate aminotransferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liverand heart disease." CFR 862.1100 Intended for the the In Vitro, quantitative determination of Direct Bilirubin in human serum on the Cobas MIRA ® clinical chemistry system. This "Direct Bilirubin test system is a device intended to measure the levels of bilirubin (direct) in plasma or serum. Measurements of levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, if used in the diagnosis and treatment of the liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block." CFR 862.1110 Intended for the the In Vitro, quantitative determination of Total Bilirubin in human serum on the Cobas MIRA ® clinical chemistry system. This "Total Bilirubin test system is a device intended to measure the levels of bilirubin (Total) in plasma or serum. Measurements of levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, if used in the diagnosis and treatment of the liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block." CFR 862.1110 Intended for the the In Vitro, quantitative determination of Calcium in human serum or urine on the Cobas MIRA ® clinical chemistry system. This "Calcium test system is a device intended to measure the total calcium level in serum. Calcium 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" CFR 862.1145 Intended for the the In Vitro, quantitative determination of Total CO2 in human serum on the Cobas MIRA ® clinical chemistry system. This " bicarbonatel carbon dioxide test system is a device intended to measure the total bicarbonate/carbon dioxide plasma, serum and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid base balance. " CFR 862.1160 Intended for the the In Vitro, quantitative determination of Chloride in human serum on the Cobas MIRA ® clinical chemistry system. This " Chloride test system is a device intended to measure the Chloride in plasma, serum, sweat and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. " CFR 862.1170 Intended for the the In Vitro, quantitative determination of Cholesterol in human serum on the Cobas MIRA ® clinical chemistry system. This " Cholesterol test system is a device intended to measure the Cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. " CFR 862.1175 Intended for the In Vitro, quantitative determination of Creatinine in human serum and urine on the Cobas MIRA ® clinical chemistry system. This " Creatinine test system is a device intended to measure the Creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases,in monitoring renal dialysis, and a calculation basis for measuring other urine analytes. " CFR 862.1225 Intended for the the In Vitro, quantitative determination of Glucose in human serum and urine on the Cobas MIRA ® clinical chemistry system. This " Glucose test system is a device intended to measure the Glucose levels in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus,neonatal hypoglycemia , idiopathic hypoglycemia and pancreatic islet cell carcinoma. " CFR 862.1360 Intended for the the In Vitro, quantitative determination of Iron in human serum on the Cobas MIRA ® clinical chemistry system. This " Iron (non-heme) test system is a device intended to measure Iron (non-heme)in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia , hemochromatosis ( a disease associated with widespread deposit in the tissues of two iron containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin) and chronic renal disease. " CFR 862.1410 Intended for the In Vitro, quantitative determination of Magnesium in human serum and urine on the Cobas MIRA ® clinical chemistry system. This " Magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnasemia (abnormally high levels of magnesium). " CFR 862.1495 Intended for the the In Vitro, quantitative determination of Inorganic Phosphorus in human serum or urine on the Cobas MIRA ® clinical chemistry system. This " Phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases , and vitamin D imbalance. " CFR 862.1580 Intended for the the In Vitro, quantitative determination of Total Protein in human serum on the Cobas MIRA ® clinical chemistry system. This " Total Protein test system is a device intended to measure Total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney or bone marrow as well as other metabolic or nutritional disorders " CFR 862. 1635 Intended for the the In Vitro, quantitative determination of Triglycerides in human serum on the Cobas MIRA ® clinical chemistry system. This " Triglyceride test system is a device intended to measure Triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. " CFR 862.1705 Intended for the the In Vitro, quantitative determination of Urea Nitrogen in human serum or urine on the Cobas MIRA ® clinical chemistry system. This " urea nitrogen test system is a device intended to measure urea nitrogen (an end product of nitrogen metabolism) in whole blood, serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. " CFR 862.1770 Intended for the the In Vitro, quantitative determination of Unbound Iron-Binding Capacity (UIBC) in human serum on the Cobas MIRA ® clinical chemistry system. This " Iron-binding capacity test system is a device intended to measure Iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. " CFR 862.1415 Intended for the the In Vitro, quantitative determination of Uric Acid in human serum or urine on the Cobas MIRA ® clinical chemistry system. This " Uric Acid test system is a device intended to measure uric acid in serum, plasma or urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. " CFR 862.1775

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For the quantitative determination of alanine aminotransferase in serum. For IN VITRO diagnostic use. Elevated levels of alanine aminotransferase result from a myocardial infarction, or hepatic disease. In cases of hepatic necrosis, elevations of ALT levels occur prior to the onset of clinical symptoms such as jaundice. To a lesser extent levels are indicative of diseases of some internal organs.

Alanine Aminotransferase-SL Assay