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VITROS® Automation Solutions is intended to automate pre-analytical sample processing in the clinical laboratory. VITROS® Automation Solutions allows the consolidation of software, automation modules and clinical analyzers, such as VITROS® Systems into a unified workstation to perform a variety of assays such as total T4, carbamazepine and gentamicin. Carbamazepine measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose. Gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. Total thyroxine (T4) measurements are used to aid in the differential diagnosis of thyroid disease.

VITROS® Automation Solutions is a configurable, scalable laboratory automation system (LAS) designed to streamline pre and post analytical processes in the clinical laboratory. VITROS® Automation Solutions is comprised of personal computer (PC) Kit(s) (including software and hardware), sample conveyors with turns, parallel and perpendicular bypasses, storage module, single-tube entry, rack entry and exit, centrifuge, de-capper modules and clinical analyzers. In the basic configuration, patient sample tubes are loaded onto the automation track to be centrifuged, de-capped, and sorted for further processing on clinical analyzers such as the VITROS® Systems. Additional modules may be added to enable aliquot capability, sample capping, and refrigerated storage. Parallel and perpendicular bypasses are extensions of the automation track that link with an analyzer's existing laboratory automation system (LAS) interface. These bypasses support on-track metering at the analyzer based on point-in-space pipetting technology and robotic interface module (RIM). With point in space pipetting, the automation performs the sample bar code read function, presents the sample identification to the connected analyzer, and then signals for direct sampling of the open tube by the connected analyzer at an aspiration point on the automation track. With robotic interface modules, the sample tube is transferred to the analyzer and the analyzer will read the bar code to identify the sample, aspirate sample from the tube and perform the test(s) requested and then return the tube to the LAS. VITROS® Automation Solutions allows the establishment of a connection with clinical analyzers such as VITROS® Systems to enable sample routing based on reagent and calibration status. The clinical analyzers, such as VITROS® Systems, will perform all functions with respect to result generation, including sample metering, assay processing and reporting for the assays. The VITROS® Systems are fully automated, computer controlled, clinical chemistry and immunodiagnostic analyzers intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, drugs of abuse, proteins, infectious diseases, as well as cardiac, metabolic, thyroid, anemia, and oncology markers in biological fluids such as serum, plasma, urine and cerebral spinal fluid. The VITROS® Systems operate in conjunction with VITROS® Immunodiagnostic and Chemistry Products, reagents, calibrators and controls designed for use with the systems in the MicroSlide, MicroTip or MicroWell format. Representative assays (carbamazepine, gentamicin and total thyroxine) are used to demonstrate acceptable performance.

The ARCHITECT iGentamicin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy. The ARCHITECT iGentamicin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma.

The ARCHITECT iGentamicin assay is a one-step immunoassay for the quantitative determination of gentamicin in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex. In the ARCHITECT iGentamicin assay, sample, anti-gentamicin coated paramagnetic microparticles, and gentamicin acridinium-labeled conjugate are combined to create a reaction mixture. The anti-gentamicin coated microparticles bind to the gentamicin present in the sample and to the acridinium-labeled conjugate. After washing, pre-trigger and 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 gentamicin in the sample and the RLUs detected by the ARCHITECT i 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.

The Multigent® Gentamicin assay is intended for the quantitative determination of Gentamicin in human serum or plasma on the Architect C8000 System. The results obtained are used in the diagnosis and treatment of Gentamicin overdose and in monitoring levels of Gentamicin to ensure appropriate therapy.

The Multigente Gentamicin 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-gentamicin monoclonal antibody and R2: gentamicin-coated microparticles. A six-level set of Multigent" Gentamicin Calibrators (A through F) is used to calibrate the assay.

1. For in vitro diagnostic use only. VITROS Chemistry Products GENT Reagent is used to quantitatively measure gentamicin (GENT) concentration in human serum and plasma. Serum or plasma gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. 2. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 13 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of gentamicin (GENT). 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 GENT on VITROS Chemistry Systems.

The VITROS Chemistry Products GENT Reagent. VITROS Chemistry Products Calibrator Kit 13, and the VITROS Chemistry Products TDM Performance Verifiers are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS GENT assay. VITROS Chemistry Products GENT Reagent is a dual chambered package containing ready-to-use liquid reagents that are used in a two-step reaction to quantitatively measure gentamicin. VITROS Chemistry Products Calibrator Kit 13 and TDM Performance Verifiers are packaged and sold separately. VITROS Chemistry Products Calibrator Kit 13 is a liquid ready to use calibrator set for gentamicin. 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).

The Roche ONLINE Gentamicin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

The Roche ONLINE Gentamicin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Gentamicin reagent kits.

The Randox Laboratories Ltd. Gentamicin Test Kit is an in vitro diagnostic reagent for the quantitative determination of gentamicin in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Immunoglobulin is covalently coupled to latex particles which will agglutinate in the presence of gentamicin antibody. When a sample containing gentamicin is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of gentamicin in the sample. By monitoring the change in scattered light or absorbance, a concentration curve can be generated. The rate of change in scattered light or absorbance is inversely proportional to the concentration of gentamicin in the sample. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. These Application Sheets have been developed for the Hitachi 717 and Advia 1650 analysers and are for use by suitably qualified laboratory personnel under appropriate laboratory conditions.

The Randox Laboratories Ltd. Gentamicin Test Kit is an in vitro diagnostic reagent for the quantitative determination of gentamicin in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Immunoglobulin is covalently coupled to latex particles which will agglutinate in the presence of gentamicin antibody. When a sample containing gentamicin is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of gentamicin in the sample. By monitoring the change in scattered light or absorbance, a concentration curve can be generated. The rate of change in scattered light or absorbance is inversely proportional to the concentration of gentamicin in the sample.

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

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

The Emit® 2000 N-Acetylprocainamide Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of N-Acetylprocainamide in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of N-Acetylprocainamide overdose or in monitoring levels of N-Acetylprocainamide to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.

The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles. Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.

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.