Search Results

The ARCHITECT i Theophylline assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of theophylline in human serum or plasma on the ARCHITECT i System with STAT protocol capability. Theophylline is used in the treatment of bronchospasm associated with bronchial asthma, chronic bronchitis and pulmonary emphysema. The measurements obtained are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to help ensure appropriate therapy. The ARCHITECT i Theophylline Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of theophylline in human serum and plasma.

The ARCHITECT iTheophylline assay is a one-step STAT immunoassay for the quantitative determination of theophylline in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex. Sample, anti-theophylline coated paramagnetic microparticles, and theophylline acridinium-labeled conjugate are combined to create a reaction mixture. The antitheophylline coated microparticles bind to theophylline present in the sample and to the theophylline acridinium-labeled conjugate. After washing, pre-trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of theophylline in the sample and the RLUs detected by the ARCHITECT / System optics.

The DGTX method is an in vitro diagnostic test for the quantitative measurement of digitoxin in serum and plasma on the Dimension Vista™ System. Measurements of digitoxin are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy. The DIG method is an in vitro diagnostic test for the quantitative measurement of digoxin in serum and plasma on the Dimension Vista™ System. Measurements of digoxin are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy. The GENT method is an in vitro diagnostic test for the quantitative measurement of gentamicin, an aminoglycoside antibiotic, in human serum and plasma on the Dimension Vista™ System. Gentamicin measurements may be used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. The NAPA method is an in vitro diagnostic test for the quantitative measurement of N-acetylprocainamide in serum and plasma on the Dimension Vista™ System. N-acetylprocainamide measurements may be used in therapeutic drug monitoring to maintain adequate procainamide therapy. The PTN method is an in vitro diagnostic test for the quantitative measurement of phenytoin, (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma on the Dimension Vista™ System. Phenytoin measurements may be used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy. The THEO method is an in vitro diagnostic test for the quantitative measurement of theophylline in human serum and plasma on the Dimension Vista™ System.

Dade Behring Dimension VistaTM 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 VistaTM 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.

1. For in vitro diagnostic use only. VITROS Chemistry Products CAFFN Reagent Kit is used on the VITROS 5,1 FS Chemistry System to quantitatively measure caffeine (CAFFN) concentration in human serum and plasma of subjects undergoing therapy with caffeine, especially for cases of neonatal apnea. 2. 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 CAFFN on VITROS Chemistry Systems.

The VITROS 5,1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens. The VITROS 5,1 FS Chemistry System is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays. The system is comprised of four main elements: 1. The VITROS 5,1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5,1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924). 2. The VITROS Chemistry Products range of MicroTip assays, in this case the VITROS Chemistry Products CAFFN Reagent Kit (Reagents 1 and 2, Buffer and Calibrators) and the VITROS Chemistry Products TDM Performance Verifiers, which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS CAFFN assay. 3. The VITROS Chemistry Products Thin Film range of products, which are dry, multilavered, analytical elements, coated on polyester supports. The thin film products each have their own 510(k) clearance numbers and were cleared for market for use on the VITROS 5.1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5,1 FS Chemistry System premarket notification (K031924). 4. Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 3). The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

The Emit® Caffeine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of caffeine levels in human serum in subjects undergoing therapy with caffeine, especially in cases of neonatal apnea.

The Emit® Caffeine Assay is a homogeneous enzyme immunoassay technique used for the analysis of specific compounds in biological fluids. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate deyhdrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD) to NADH. resulting in an absorbance change that can be measured spectrophotometrically.

The Roche ONLINE Theophylline assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of theophylline, a broncodilator, widely used to treat patients with asthma, apnea (temporary asphyxia), and other obstructive lung diseases. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.

The Roche ONLINE Theophylline assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of theophylline, a bronchodilator, widely used to treat patients with asthma, apnea (temporary asphyxia), and other obstructive lung diseases, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to ensure appropriate therapy. The proposed labeling indicates that the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Theophylline reagent kits.

The Randox Laboratories Ltd. Theophylline Test Kit is an in vitro diagnostic reagent for the quantitative determination of theophylline in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Latex particles are coated with theophylline which, in the presence of theophylline antibody solution, rapidly agglutinate. When a sample containing theophylline is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agdutination is inversely dependent on the concentration of theophylline in the sample. By monitoring the change in scattered light as a change in absorbance, a concentration curve can be obtained. The actual change in absorbance is inversely proportional to the concentration of theophylline in the sample. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to ensure appropriate therapy. This Application Sheet has been developed for the Hitachi 717 analyser and must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

The Randox Laboratories Ltd. Theophylline Test Kit is an in vitro diagnostic reagent for the quantitative determination of theophylline in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Latex particles are coated with theophylline which, in the presence of theophylline antibody solution, rapidly agglutinate. When a sample containing theophylline is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agdutination is inversely dependent on the concentration of theophylline in the sample. By monitoring the change in scattered light as a change in absorbance, a concentration curve can be obtained. The actual change in absorbance is inversely proportional to the concentration of theophylline in the sample.

The ACS:180 and ADVIA Centaur Theophylline 2 Immunoassays are competitive, chemiluminescence immunoassay for the quantitative determination of theophylline in human serum and plasma for use on the automated analyzer manufactured by Bayer Corporation. Theophylline (1,3-dimethylxanthine) is a potent bronchodilator and is very important in the treatment of asthma. Monitoring a patient's theophylline level is very important in reducing the risks of over or under-medication resulting from the wide inter-patient variation in theophylline absorption, metabolism and excretion. The ACS and ADVIA Centaur Theophylline 2 immunoassays are used as an aid to monitor a patient's theophylline level.

The ACS and ADVIA Centaur Theophylline 2 are competitive chemiluminescence immunoassays are intended for the quantitative determination of theophylline in human serum and plasma. Theophylline in the patient sample, calibrators, standards and controls competes with acridinium ester-labeled theophylline in the Lite Reagent for a limited amount of monoclonal mouse anti-theophylline antibody, which is covalently coupled to paramagnetic particles in the Solid Phase. Following incubation, unreacted acridinium esterlabeled theophylline and unreacted theophylline from the sample are washed from the reaction mixture. The chemiluminescence of the reacted, labeled theophylline is measured in a luminometer. The measured chemiluminescence is inversely proportional to the quantity of theophylline in the sample.

The Abbott Aeroset® Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma on the Abbott Aeroset® System.

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990. Syva Company is submitting the Premarket Notification, 510(k) on behalf of Abbott Laboratories to convey Abbott's intention to commercially market an in vitro diagnostic reagent test kit for the analysis of theophylline in human serum or plasma. The Abbott Aeroset® Theophylline Assay is a homogenous enzyme assay intended for use in quantitative analysis of theophylline in human serum or plasma. The Abbott Aeroset® Theophylline Assay and calibrators has been found to be equivalent to the predicate device: Emit® 2000 Theophylline Assay (K913123) with regard to intended use, assay sample, and overall performance characteristics.

The JMMAGE Immunochemistry System (TDM) CAR. PHE. PHY. and THE Reagents in conjunction with Beckman Drug Calibrator 1, are intended for use in the quantitative determination of carbamazepine. phenobarbital, phenytoin, and theophylline concentrations respectively in human serum and plasma samples on Beckman's IMMAGE Immunochemistry System. The IMMAGE Immunochemistry System Carbamazepine (CAR) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of carbamazepine in human serum or plasma bv rate nephelometric inhibition immunoassay. The IMMAGE Immunochemistry System Phenobarbital (PHE) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of phenobarbital in human serum or plasma bv rate nephelometric inhibition immunoassay. The IMMAGE Immunochemistry System Phenytoin (PHY) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of phenytoin in human serum or plasma by rate nephelometric inhibition immunoassay. The IMMAGE Immunochemistry System Theophylline (THE) reagent when, used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of theophylline in human serum or plasma by rate nephelometric inhibition immunoassay. The IMMAGE™ Immunochemistry Systems Drug Calibrator 1, used in conjunction with IMMAGE reagents, is intended for use on Beckman's IMMAGE Immunochemistry Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, and Theophylline test systems.

The JMMAGE Immunochemistry System (TDM) CAR. PHE. PHY. and THE Reagents in conjunction with Beckman Drug Calibrator 1, are intended for use in the quantitative determination of carbamazepine. phenobarbital, phenytoin, and theophylline concentrations respectively in human serum and plasma samples on Beckman's IMMAGE Immunochemistry System.