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The Alc iGear is intended for in vitro diagnostic use only for the quantitative measurement of the percent hemoglobin A1c (%HbA1c) from fingerstick blood or venous whole blood collected in either EDTA or sodium fluoride (NaF) for clinical laboratory and point of care use. The measurement of HbA1c is recommended to monitor long-term glycemic control of persons previously diagnosed with diabetes mellitus. This test is not for screening or diagnosis of diabetes.

A1c iGear is a fully automated, desktop, electrical spectrophotometer that measures %HbA1c in human whole blood using a dedicated reagent (MEDIDAS HbA1c). The system shines light from a 660 nm light emitting diode (LED) through the test material and measures the percent of hemoglobin A1c in the total hemoglobin (%HbA1c) based on the lot-specific reagent parameters and changes in light absorbency caused by antigen-antibody reactions. MEDIDAS HbA1c (the reagent component) is composed of a test cartridge, capillary, pipette tip and master calibration card. The cartridge is pre-filled with the reagent; namely latex (Reagent 1: R1), antibody (Reagent 2: R2), and sample diluent solution. The A1c iGear and MEDIDAS HbA1c assay utilize an immuno-turbidimetric method to determine the percentage of HbA1c in total hemoglobin directly.

The Alc GEAR System is intended for in vitro diagnostic use only for the quantitative measurement of the percent hemoglobin A 1 (%HbA1c) from finger-stick blood or venous whole blood collected in either EDTA or sodium fluoride (NaF) for clinical laboratory and point of care use. The measurement of HbAlc is recommended to monitor long-term glycemic control of persons previously diagnosed with diabetes mellitus. This test is not for screening or diagnosis of diabetes.

The Alc GEAR instrument is a fully automated desktop electric spectrophotometer that measures %HbAlc in human whole blood using a dedicated reagent (MEDIDAS HbA1c). The system illuminates a 660 nm LED (Light Emitting Diode) through the test material and quantitatively measures the percent of hemoglobin Alc in the total hemoglobin (%HbA1c) by means of light absorbance changes and a non-linear calibration curve. The system includes the Hemoglobin A Ic Analyzer (Alc GEAR), thermal printer, barcode reader, power cable, and fan filter. MEDIDAS HbAIc is composed of a test cartridge, capillary, pipette tip and master calibration card. The cartridge is pre-filled with reagent; latex (reagent R1), antibody (reagent R2), and sample dilute solution.