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The ADVIA Centaur Cyclosporine assay is an in vitro diagnostic immunoassay for the quantitative determination of cyclosporine in human whole blood using the ADVIA Centaur systems. This assay is intended for use as an aid in the management of cyclosporine therapy in kidney, heart, and liver transplant patients.

The ADVIA Centaur® Cyclosporine assay is a competitive immunoassay using direct chemiluminescent technology. Cyclosporine in the patient sample competes with acridinium ester-labeled cyclosporine in the Lite Reagent for a limited amount of biotin-labeled monoclonal mouse anti-cyclosporine antibody. Biotinlabeled anti-cyclosporine binds to streptavidin that is covalently coupled to paramagnetic particles in the Solid Phase. In the ADVIA Centaur® Cyclosporine assay the sample is manually pretreated to lyse the cells and solubilize the cyclosporine. An inverse relationship exists between the amount of cyclosporine present in the patient sample and the amount of relative light units (RLUs) detected by the system.

The ARCHITECT Cyclosporine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood on the ARCHITECT i System. The ARCHITECT Cyclosporine assay is used as an aid in the management of heart, liver, and kidney transplant patients receiving cyclosporine therapy. The ARCHITECT Cyclosporine Calibration are for the ARCHITECT i System when used for the quantitative determination of cyclosporine in human whole blood. The ARCHITECT Cyclosporine Whole Blood Precipitation Reagent is for the extraction of cyclosporine from samples (human whole blood patient specimens, controls, and ARCHITECT Cyclosporine Calibrators) to be tested on the ARCHITECT i System.

The ARCHITECT Cyclosporine assay is a two-step immunoassay for the quantitative determination of cyclosporine in human whole blood using CMIA technology with flexible assay protocols, referred to as Chemiflex. Prior to the initiation of the automated ARCHITECT sequence, a manual pretreatment step is performed in which the whole blood sample is lysed with a solubilization reagent, extracted with a precipitation reagent and centrifyged. The supernatant is decanted into a Transplant Pretreatment Tube, which is placed onto the ARCHITECT i System. In the first step, sample, assay diluent, and anti-cyclosporine coated paramagnetic microparticles are combined to create a reaction mixture. Cyclosprorine present in the sample binds to the anti-cyclosporine coated microparticles. After washing, cyclosporine acridiniumlabeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle, 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 cyclosporine in the sample and the RLUs detected by the ARCHITECT i System optics.

The CSAE method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista® system. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.

The Dimension Vista® CSAE Flex® reagent cartridge is a pre-packaged in-vitro diagnostic test method (assay) that is specifically designed to be used on the 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 (K051087). This Special 510(k) is submitted for a packaging modification to the Dimension® Cyclosporine Extended Range (CSAE) Flex® reagent cartridge (K052017), an in-vitro diagnostic device that has 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 modifications also include a change in method parameters (sample size and reagent volume) but the final concentration of sample/reagent ratio in test milieu remains the same. The reagents contained in the Dimension Vista® CSAE Flex® reagent cartridges are the same as those contained in the Dimension® CSAE Flex® reagent cartridges manyfactured for the Dimension® clinical chemistry systems, another family of Siemens analyzers. The packaging modification does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the device. The CSAE method uses an immunoassay technique in which free and CSA bound antibody-enzyme species are separated using magnetic particles. The CSAE Flex® reagent cartridge contains a pretreatment reagent, B-galactosidase-CSA antibody conjugate, CSA immobilized on chromium dioxide particles, chlorophenol red B-dgalactopyranoside (CPRG) substrate, and diluent to hydrate the tablets. To perform the CSAE assay, a sample cup containing the whole blood sample to be analyzed and a CSAE Flex® reagent cartridge are placed appropriately on the Dimension Vista® system. The Dimension Vista® system mixes and lyses the whole blood sample. The lysed sample is then mixed with the antibody conjugate reagent. The CSA present in the sample is bound by the CSA antibody conjugate reagent. Magnetic particles coated with cyclosporine A are added to bind free (unbound) antibody-enzyme conjugate. The reaction mixture is then separated magnetically. Following separation, the supernatant containing the CSA antibody-enzyme complex is transferred to a cuvette and mixed with the substrate. B-galactosidase catalyzes the hydrolysis of CPRG (chlorophenol red B-dgalactopyranoside) to produce CPR (chlorophenol red) that absorbs light maximally at 577mm. The change in absorbance at 577nm due to the formation of CPR is directly proportional to the amount of CSA in the patient's sample and is measured using a bichromatic (577, 700nm) rate technique.

The CSA method is an in vitro diagnostic test for the quantitative measurement of Cyclosporine A (CSA) in human whole blood on the Dimension Vista™ System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients. The Dimension Vista™ Cyclosporine (CSA) Flex® reagent cartridge is an in vitro device intended to quantitatively determine cyclosporine concentrations in human whole blood. Measurements of CSA are used as an aid in the management of heart, liver, and kidney transplant patients receiving therapy with this drug.

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 (K051087). This Special 510(k) is submitted for a packaging modification to the Dimension® Cyclosporine (CSA) Flex® reagent cartridge (K023065), an in-vitro diagnostic device that has been cleared under the 510(k) process. The packaging change is to allow use on the Dimension Vista™ system. The reagents contained in the Dimension Vista™ CSA Flex® reagent cartridges are the same as those contained in the CSA 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 device, nor does it alter the fundamental scientific technology of the device.

The Emit® 2000 Cyclosporine Specific Assay is for in vitro quantitative analysis of cyclosporine (CsA) in human whole blood as an aid in the management of cyclosporine therapy in kidney, heart and liver transplant patients.

The Emit® 2000 Cyclosporine Specific Assay employs a homogeneous enzyme immunoassay technique used for the analysis of cyclosporine in whole blood. The assay contains mouse monoclonal antibodies with a high specificity for cyclosporine. The Emit® 2000 Cyclosporine Specific Assay is based on competition for cyclosporine antibody binding sites. Cyclosporine in the sample competes with cyclosporine in Enzyme Reagent B that is labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH). Active (unbound) enzyme converts the oxidized nicotinamide adenine dinucleotide (NAD) in Antibody Reagent A to NADH, resulting in a kinetic absorbance change that can be measured spectrophotometrically. Enzyme activity decreases upon binding to the antibody, allowing the cyclosporine concentration in the sample to be measured in terms of enzyme activity. Endogenous serum G6PDH does not interfere because the coenzyme NAD functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.

The Cyclosporine CSAE Flex® reagent cartridge is an in vitro diagnostic test intended to quantitatively measure cyclosporine A (CSA) in human whole blood for the Dimension® clinical chemistry system. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.

The Dimension® CSAE Cyclosporine Flex® reagent cartridge (DF108) is an in vitro rine Differences that consists of prepackaged reagents in a plastic eight well cartridge for use on the Dade Behring Dimension® clinical chemistry system for the quantitative determination cyclosporine A (CSA) in human whole blood.

The AxSYM Cyclosporine assay is a Fluorescence Polarization Immunoassay (FPIA) in vitro reagent system for the quantitative measurement of cyclosporine (cyclosporine A) in human whole blood as an aid in the management of cardiac, liver, and renal transplant patients.

The AxSYM Cyclosporine assay requires the use of the AxSYM System, a random and continuous access immunoassay analyzer performs all sample and reagent transfers, incubations, and data processing, and completes the assay with a printed report. Samples (calibrators, controls, and specimens) are pretreated to minimize interference from endogenous protein-bound fluorescent compounds. Sample pretreatment consists of lysing the erythrocytes in the whole blood with Solubilization Reagent and precipitating protein with Precipitation Reagent. Cyclopsorine is dissolved into the liquid phase. The mixture is centrifuged to generate a clarified extract. The AxSYM Cyclopsorine assay is performed on the clarified extract. The AxSYM Cyclosporine Reagents and pretreated sample are pipetted in the following sequence: - Pretreated sample, Cyclosporine Antibody, Cyclosporine Pretreatment and Solution 4 (Line Diluent) required for one test are pipetted by the Sample Probe into one well of a Reaction Vesssel (RV) to form a Sample Solution, - Cyclosporine Fluorescein Tracer is added to a second well of the RV. - The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center by the Processing Probe. - Aliquots of Solution 4 and Sample Solution are dispensed into the RV curvette. - The polarized fluorescent background is measured by the FPIA optical assembly. - Second aliquots of Solution 4 and Sample Solution, and an aliquot of . Cyclosporine Fluorescein Tracer are dispensed into the same RV curvette. - The intensity of polarized fluorescent light is measured by the FPIA optical assembly.

The CEDIA Cyclosporine Plus Assay is for the quantitative determination of cyclosporine in human whole blood using automated clinical chemistry analyzers as an aid in the management of therapy in kidney, liver, and heart transplants. The CEDIA Cyclosporine Calibrators are used to calibrate the CEDIA Cyclosporine Plus Assay in human whole blood.

The CEDIA Cyclosporine Plus Assay is a two-reagent set intended to be used with automated clinical chemistry analyzers. The assay uses recombinant DNA technology (US Patent No. 4708929) to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß galactosidase, which has been genetically engineered into two inactive fragments, termed Enzyme Acceptor (EA) and Enzyme Donor (ED) spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, to generate a color change that can be measured spectrophotometrically. In the CEDIA Cyclosporine Plus Assay, drug in the sample competes with drug conjugated to ED for antibody binding sites. If drug is present in the sample, it binds to antibody, leaving the EDdrug conjugate free to reassociate with EA to form active ß-galactosidase. If no drug is present in the sample, antibody binds to the ED-cyclosporine conjugate, inhibiting the reassociation of inactive B-galactosidase fragments, and thus reducing the amount of active enzyme formed. The amount of active enzyme formed, and resulting absorbance change, is proportional to the amount of CEDIA Cyclosporine Plus Assay present in the sample.

The CSA Flex® reagent cartridge is an in vitro diagnostic test intended to quantitatively measure cyclosporine A (CSA) in human whole blood for the Dimension® clinical chemistry system. Measurements of CSA are used as an aid in the management of heart, liver, and kidney transplant patients.

The automated Dimension® CSA method uses an immunoassay technique in which free and CSA-bound antibody-enzyme species are separated using magnetic particles. Following separation, the CSA-antibody-enzyme complex is mixed with the substrate. Bgalactosidase catalyzes the hydrolysis of CPRG (chlorophenol red ß-d- galactopyranoside) to produce CPR (chlorophenol red) that absorbs light maximally at 577 nm. The change in absorbance at 577 nm due to the formation of CPR is directly proportional to the amount of CSA in the patient's sample and is measured using a bichromatic (577, 700 nm) rate technique.