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The QMS® Tobramycin assay is intended for the quantitative determination of tobramycin in human serum or plasma on automated clinical chemistry analyzers. The results obtained are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to help ensure appropriate therapy.

The QMS® Tobramycin assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle. The assay consists of reagents R1: anti- tobramycin monoclonal antibody and R2: tobramycin -coated microparticles. A six-level set of QMS® Tobramycin Calibrators (A through F) is used to calibrate the assay.

The Dimension Vista™ Acetaminophen (ACTM) Flex® reagent cartridge is a device intended to measure acetaminophen, an analgesic and antipyretic (fever reducing) drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose. The Dimension Vista™ Amylase (AMY) Flex® reagent cartridge is a device intended to measure the activity of the enzyme amylase in serum, plasma and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). The Dimension Vista™ Creatine Kinase (CK) Flex® reagent cartridge is a device intended to measure the activity of the enzyme creatine kinase in serum and plasma. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive Duchenne-type muscular dystrophy. The Dimension Vista™ Cholesterol (CHOL) Flex® reagent cartridge is a device intended to measure cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. The Dimension Vista™ Gamma-glutamyl transferase (GGT) Flex® reagent cartridge is a device intended to measure gamma-glutamyl transferase in human serum and plasma. Gamma-glutamyl transferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors. The Dimension Vista™ Glucose (GLU) Flex® reagent cartridge is a device intended to measure glucose in human serum, plasma, urine and cerebrospinal fluid. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal and idiopathic hypoglycemia, and pancreatic islet cell carcinoma. The Dimension Vista™ High-Density Lipoprotein Cholesterol (HDLC) Flex® reagent cartridge is intended to measure high-density lipoprotein cholesterol in serum and plasma. Measurements of high-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The Dimension Vista™ Low-Density Lipoprotein Cholesterol (LDLC) Flex® reagent cartridge is intended to measure low-density lipoprotein cholesterol in serum and plasma. Measurements of low-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The Dimension Vista™ Lidocaine (LIDO) Flex® reagent cartridge is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy. The Dimension Vista™ Magnesium (MG) Flex® reagent cartridge is intended for the measurement of magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). The Dimension Vista™ Pseudocholinesterase (PCHE) Flex® reagent cartridge is a device intended to measure pseudocholinesterase activity in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning). The Dimension Vista™ Phosphorus (PHOS) Flex® reagent cartridge 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. The Dimension Vista™ Procainamide (PROC) Flex® reagent cartridge is a device intended to measure procainamide in serum and plasma. Measurements obtained may be used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to ensure appropriate therapy. The Dimension Vista™ Salicylate (SAL) Flex® reagent cartridge is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human serum. Measurements obtained by this device are used in the diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy. The Dimension Vista™ Thyroxine (T4) Flex® reagent cartridge is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases. The Dimension Vista™ Tobramycin (TOBR) Flex® reagent cartridge is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in palsma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy. The Dimension Vista™ Triglyceride (TRIG) Flex® reagent cartridge 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. The Dimension Vista™ Uric Acid (URCA) Flex® reagent cartridge is a device intended to measure uric acid in serum, plasma, and 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. The Dimension Vista™ Valproic Acid (VALP) Flex® reagent cartridge is a device intended to measure valproic acid, an anti-convulsant drug in serum and plasma. Measurements obtained may be used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy. The Dimension Vista™ Vancomycin (VANC) Flex® reagent cartridge is a device intended to measure vancomycin, an antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Vade 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 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.

The ONLINE TDM Tobramycin assay is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in human plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.

The ONLINE TDM Tobramycin assay is for the quantitative determination of tobramycin in human serum or plasma on Roche automated clinical chemistry analyzers. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Tobramycin reagent kits.

1. For in vitro diagnostic use only. VITROS Chemistry Products TOBRA Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure tobramycin (TOBRA) concentration in human serum and plasma. Serum or plasma tobramycin measurements are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy. 2. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 14 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of tobramycin (TOBRA). 3. For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assayed control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and TOBRA on VITROS Chemistry Systems.

The VITROS Chemistry Products TOBRA Reagent, VITROS Chemistry Products Calibrator Kit 14, and the VITROS Chemistry Products TDM Performance Verifiers are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS TOBRA assay. VITROS Chemistry Products TOBRA Reagent is a dual chambered package containing ready-to-use liquid reagents that are used in a two-step reaction to quantitatively measure tobramycin. VITROS Chemistry Products Calibrator Kit 14 and TDM Performance Verifiers are packaged and sold separately. VITROS Chemistry Products Calibrator Kit 14 is a liquid ready to use calibrator set for tobramycin. Each kit contains one bottle each of six (6) levels. The level 1 bottle (zero level) contains 5 milliliters. The level 2 through 6 bottles each contain 2 milliliters. VITROS Chemistry Products TDM Performance Verifier I, II and III are liquid ready to use controls with assayed values published for each lot. The controls are prepared from bovine serum with therapeutic drugs and preservatives added. The product is sold in separate kits of Level I, II and III. Each kit contains 6 vials (2 mL each).

For in vitro diagnostic use with the IMMULITE 2000 Analyzer – for the quantitative measurement of tobramycin in serum or plasma, as an aid in monitoring the therapeutic administration of this aminoglycoside.

IMMULITE® 2000 Tobramycin is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE® 2000 Automated Analyzer.

The Chiron Diagnostics ACS:180 Tobramycin Assay is for the quantitative determination of tobramycin in serum or plasma using the Chiron ACS:180 Automated Chemiluminescence Systems. Monitoring the patient's serum or plasma tobramycin levels is important both to ensure that the drug is present in therapeutic concentrations and to avoid toxicity.

The Chiron Diagnostics ACS:180 Tobramycin assay is a competitive immunoassay using direct, chemilumenescent technology. Tobramycin in the patient sample competes with acradinium ester-labeled tobramycin in the Lite Reagent for a limited amount of monoclonal mouse anti-tobramycin antibody, which is covalently coupled to the paramagnetic particles in the Solid Phase. An inverse relationship exists between the amount of tobramycin present in the patient sample and the amount of relative light units (RLUs) detected by the ACS:180® system.

The IMMAGE Immunochemistry System Gentamicin (GEN) reagent, when used in coniunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 3 Plus, is intended for the quantitative determination of cgentamicin in human serum or plasma by rate nephelometric inhibition immunoassay. The IMMAGE Immunochemistry System Tobramycin (TOB) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 3 Plus, is intended for the quantitative determination of tobramycin in human serum or plasma by rate nephelometric inhibition immunoassay. Becknan Drug Calibrator 3 Plus, used in conjunction with IMMAGE reagents, is intended for use on Beckman's IMMAGE™ Immunochemistry Systems for the calibration of Gentamicin and Tobramycin test systems.

The IMMAGE Immunochemistry System (TDM) GEN and TOB Reagents in conjunction with Beckman Drug Calibrator 3 Plus, are intended for use in the quantitative determination of gentamicin and tobramycin concentrations respectively in human serum and plasma samples on Beckman's IMMAGE Immunochemistry System.

COBAS INTEGRA Gamma- Glutamyltransferase - IFCC: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of GGT, (EC 2.3.2.2, y-glutamyl peptide: amino acid y-glutamyltransferase) in serum and plasma (test GGTI, 0-562). COBAS INTEGRA Lactate Dehydrogenase - IFCC: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of LDH (EC 1.1.1.27; L-lactate: NAD oxidoreductase ) in serum and plasma (test LDHI, 0-181). COBAS INTEGRA Total Protein - urine and CSF: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the total protein concentration in urine and cerebrospinal fluid (tests TPU, 0-123 and TPC, 0-223). COBAS INTEGRA Lactate: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the lactate concentration in plasma and cerebrospinal fluid (tests LACT, 0-22 and LACTC, 0-122). COBAS INTEGRA Tobramycin: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of tobramycin in serum or heparinized plasma (test TOBR, 0-92). COBAS INTEGRA Immunoglobulin A: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the immunological determination of human immunoglobulin A in serum. In addition to the standard application (test IGA, 0-075), the sensitive application (test IGAP, 0-175) is designed for the quantitative determination of low IgA concentrations in e.g. pediatric samples. COBAS INTEGRA Immunoglobulin G: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the immunological determination of human immunoglobulin G in serum. In addition to the standard application (test IGG, 0-076), the sensitive application (test IGGP, 0-176) is designed for the quantitative determination of low IgG concentrations in e.g. pediatric samples. COBAS INTEGRA Immunoglobulin M: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the immunological determination of human immunoglobulin M in serum. In addition to the standard application (test IGM, 0-077), the sensitive application (test IGMP, 0-177) is designed for the quantitative determination of low IgM concentrations in e.g. pediatric samples.

Through this submission it is the intention of Roche to gain clearance of an additional 5 new COBAS INTEGRA Reagent Cassettes and a modified version of 3 previously cleared reagent cassettes. All of the COBAS INTEGRA Reagent Cassettes contained in this submission are intended for use with the COBAS INTEGRA Analyzer. The Analyzer provides quantitative measurement of these analytes via three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free. Sixty-eight COBAS INTEGRA Reagent Cassettes can be stored on board, 24 hours a day at 2-8 °C. Each cassette is barcoded. This barcode label provides the analyzer with specific reagent information such as the lot number, the expiration date and the number of tests.