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ST AIA-PACK CEA is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Carcinoembryonic Antigen (CEA) in human serum to aid in the management of cancer patients in whom changing concentrations of CEA are observed on specific TOSOH AIA System Analyzers.

The ST AIA-PACK CEA is a two-site immunoenzymometric assay which is performed entirely in the AIA-PACK. CEA present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the AJA-PACK. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the CEA concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.

ST AIA-PACK Testosterone is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific TOSOH AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. This device is intended "For Professional Use" only.

The ST AIA-PACK Testosterone is a competitive immunoenzymometric assay which is performed entirely in the AIA-PACK. Testosterone present in the test sample competes with enzyme-labeled testosterone for a limited number of binding sites on a testosterone-specific monoclonal antibody, immobilized on a magnetic solid phase. The magnetic beads are washed to remove urbound enzyme-labeled testosterone and are then incubated with a fluorogenic substrate, 4methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled testosterone that binds to the beads is inversely proportional to the testosterone concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.

ST AIA-PACK AFP is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Alpha-Fetoprotein (AFP) in serum to aid in the management of patients with nonseminomatous testicular carcinoma.

The ST AIA-PACK AFP is a two-site immunoenzymometric assay which is performed entirely in the AIA-PACK. AFP present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the AIA-PACK. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the AFP concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.

ST AIA-PACK CA 125 is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 125 in human serum on specific TOSOH AIA System analyzers. ST AIA-PACK CA 125 is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

The ST AIA-PACK CA 125 is a two-site immunoenzymometric assay which is performed entirely in the AIA-PACK. CA 125 present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the AIA-PACK. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbellifery| phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the CA 125 concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.

The G7 Automated HPLC Analyzer: Beta-thalassemia Mode is intended for IN VITRO DIAGNOSTIC USE ONLY for the separation and area percent determinations of hemoglobins A2 and F and as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood using ion-exchange high performance liquid chromatography (HPLC). The G7 Automated HPLC Analyzer: Beta-thalassemia Mode reagents and software are intended only for use on the Tosoh G7 Automated HPLC Analyzer.

The G7 Automated HPLC Analyzer - Beta-thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports HbF and HbA2 quantitative percentages in whole blood. A chromatographic tracing of the hemoglobin products found in the sample is also produced which allows for the comparison of an individual chromatogram with standard patterns of known composition. The operational portion of the G7 Beta-thalassemia Mode is composed of a sampling unit, liquid pump, degasser, detector, microprocessors, sample loader, floppy disk drive unit, operational panel and a printer all of which have already been cleared by the FDA (K011434). The reagents and software program specific to the Beta-thalassemia Mode consist of calibrators, elution buffers, column and software only. The G7 Automated HPLC System - Beta-thalassemia Mode uses a cation exchange column and separates the hemoglobin in the blood into fractions. The separation is accomplished by eluting the hemoglobins from the column with a gradient of three elution buffers containing increasing salt concentrations. The resulting report is printed out on the on-board printer and can be stored on a floppy disk in the on-board floppy disk drive. The data can also be transmitted to a host computer through the RS232 port. The result report includes a sample ID, date, time, area percentages and retention time in minutes of each individual peak detected. Peaks that meet the retention time "windows" pre-set in the software are labeled as F, A0, A2, D+, S+, C+. All others are designated in order of appearance as PXX and are listed in order of appearance. All automated processes in the G7 Beta-thalassemia Mode are controlled by internal microprocessors using software downloaded via the on-board floppy disk drive.

AIA-PACK cTnl 2nd-Gen is designated for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of cardiac troponin I (cTnl) in human heparinized plasma on specific TOSOH AIA System analyzers. Cardiac troponin I measurements are used as an aid in the diagnosis of acute myocardial infarction (AMI).

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The G7 Automated HPLC Analyzer is a high pressure liquid chromatography system intended for IN VITRO DIAGNOSTIC USE ONLY. Glycosylated system intended for wents obtained by this device are used in the management and treatment of diabetes.

The G7 Automated HPLC Analyzer: HbA1c Variant Analysis Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports stable A1c (SA1c) percentage in whole blood. The operational portion of the HPLC G7 is composed of a sampling unit, liquid pump, degasser, column, detector, microprocessors, sample loader, floppy disk drive unit, operation panel and a printer. The G7 uses a cation exchange column and separates the usual hemoglobin components in the blood into six fractions, A1a, A1b, F, L-A1c, SA1c and A0. The separation is done by eluting the hemoglobins from the column with a gradient of three elution buffers containing different salt concentrations. The result report is printed out from the on-board printer and can be stored on a floppy disk from the on-board floppy disk drive. The data can be transmitted to a host computer. The result report includes a sample ID, date, percentage and retention time of each fraction, SA1c percentage and total A1 percentage (A1a + A1b + SA1c) along with a chromatogram of the elution pattern of the hemoglobin fractions. If a sample contains a hemoglobin variant, the column elutes the material depending upon its charge. The software compares the retention times to "known windows" and designates the material as P0X or H-VX if it does not match a defined window. All automated processes in the G7 are controlled by internal microprocessors, using software downloaded via the on-board floppy disk drive.

AIA-PACK FOLATE is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on TOSOH AIA System analyzers.

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AIA-PACK CA 125 is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 125 in human serum on TOSOH AIA System analyzers. AIA-PACK CA 125 is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

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