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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.

ACE® Theophylline Reagent is intended for the quantitative determination of theophylline in serum using the ACE® clinical chemistry analyzer. Theophylline is a methylxanthine derivative which is widely used in the treatment of asthma, obstructive lung disease and neonatal apnea. The primary therapeutic effect of theophylline is due to relaxation of bronchial smooth muscle; however, theophylline has a variety of other effects. These include stimulation of the central nervous system and medullary respiratory centers, decreased peripheral vascular resistance, cardiac stimulation, and diuresis. In combination with other clinical data, monitoring serum theophylline levels may provide the physician with useful information to aid in adjusting patient dosage to achieve optimal therapeutic effect while avoiding drug toxicity.

The ACE® Theophylline Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to theophylline and is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD+ to NADH.

The ChemTrak AccuMeter® Theophylline Test provides a rapid, noninstrumented enzyme immunochromatographic method for in vitro quantitative measurement of Theophylline concentrations in ambulatory patients using fingerstick whole blood, heparinized venous whole blood or serum. This test has not been validated for use with blood from neonates.

The AccuMeter Theophylline Test is a rapid immunoassay for the quantitative detection of theophylline, using HRP labeled anti-theophylline antibodies and immobilized monoclonal anti-theophylline antibodies. The immunospecific signal is measured by the height of the enzyme label along the test strip.

The CEDIA Theophylline Assay is a homogeneous enzyme immunoassay for the in vitro assay of theophylline in human serum and plasma. Measurements are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to ensure proper therapy.

The CEDIA® Theophylline Assay is an in-vitro homogeneous enzyme immunoassay used for the measurement of theophylline in serum and plasma. It is based on competitive binding concepts employing theophylline labeled enzymatic fragments (β-galactosidase) competing with sample theophylline for the theophylline -specific antibody. Using recombinant DNA techniques, the β-galactosidase molecule has been split into two totally inactive polypeptide subunits called enzyme acceptor and enzyme donor. Theophylline has been covalently linked to the enzyme donor in a manner that does not prevent spontaneous reassociation of the subunits to yield active β-galactosidase enzyme. Theophylline -specific antibody, by binding to the Theophylline derivative on the enzyme donor will inhibit enzyme reassociation, thereby regulating the level of β-galactosidase formed. The amount of enzyme formed is proportional to the amount of theophylline as monitored by the hydrolysis of the substrate chlorophenol red-β-D-galactopyranoside (CPRG).