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The Avie™ Total Hb Test System is for the quantitative measurement of total hemoglobin in whole blood (capillary or venous EDTA,K2). The test system is designed for point-of-care use in primary care settings. The test system is for professional in vitro diagnostic use only.

The Avie™ Total Hb Test System is a point of care (POC) IVD system that utilizes general chemistry reactions to quantify total hemoglobin in fresh capillary blood and venous blood. The test system includes a small instrument (Reader) and disposable reagent strips- the strips are packaged in a reusable canister with desiccant, similar to the packaging of routine urine test strips. The concentration of total hemoglobin is calculated photometrically and is based on the optical intensity of the reaction within the quantitative area of the test strip. The calibration of the Avie™ Total Hb Test is traceable to the same high-order reference method as the HemoCue (hemiglobincyanide [HiCN].

The Avie™ A1C System test is a point of care system that quantitatively measures % A1C (glycated hemoglobin) in capillary and venous whole blood. The Avie™ A1C System consists of the Avie™ A1C System Reader, Avie™ A1C System Test Cartridge and Avie™ A1C System Diluent. The test is for physician directed prescription home use and professional use to monitor glycemic control in patients with diabetes mellitus. Single use, auto-disabling lancing devices are to be used in the professional setting. The device cannot be used in patients with hemoglobinopathies of Hemoglobin C and Hemoglobin D.

The Avie A1C Test is a point of care system that utilizes a Reader and disposable test cartridges to measure %A1C in whole blood samples. Whole blood from either capillary of venous is directly applied to the sample port of a test cartridge. Insertion of the test cartridge into the reader automatically prompts the operator to add diluent. Addition of diluent lyses the red bloods cell which allows both the A1C and total hemoglobin analytes to be measured. The test completes in less than three (3) minutes. Both the A1C and Total Hemoglobin (Total Hb) analytes are measured using its own distinct wavelength. Hemoglobin from the lyzed blood is converted to met-hemoglobin and is read at 420 nm. The concentration of hemoglobin is directly proportional to the intensity of met-hemoglobin concentration. For A1C the lysed blood is mixed with anti-hemoglobin antibodies conjugated to colored microparticles. After a predetermined time the microparticle mixture is automatically released onto a reagent strip where the reacted and unreacted microparticle species are separated and read optically. The final displayed result is expressed as; %A1C = (A1C = Total Hb)×100. MEC Dynamics, Corp. calibrates the Avie™ A1C System using National Glycohemoglobin Standardization Program (NGSP) certified laboratory value assigned blood samples. Lot specific information is transferred to the Avie™ AIC Reader via radio frequency identification (RFID).

The Avie A1C test is a point of care system that quantitatively measures % A1C (glycated hemoglobin) in capillary or venous whole blood samples. The test is for prescription use and physician-directed home use to monitor glycemic control in patients with diabetes mellitus. The device cannot be used in patients with hemoglobinopathies of HbF, HbC, and HbD.

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The Avie™ Alc test is a point of care system that quantitatively measures %A1C (glycated hemoglobin) in capillary or venous whole blood samples. The test is for prescription use and physician-directed home use to monitor glycemic control in people with diabetes mellitus. The device cannot be used in patients with hemoglobinopathies of HbF, HbC, and HbD.

The Avie A1C test system is for the quantitative measurement of %A1C in fingerstick whole blood at the point-of-care (Professional or Physician Directed Home Use). The system consists of a small instrument ("Reader), a single-use diluent solution vial, single-use reagent test cartridges, and control levels I and II solutions. To perform one test, the Reader is turned on by the push of a button on its top surface, and a self-check (optics and software) is performed automatically. If a malfunction is detected, the Reader displays an error message on the LCD display. When the LCD display denotes "Ready" a test cartridge is inserted into an unambiguous slot in the reader. About four uL of whole blood is delivered into a vial containing wash solution or diluent, via a transfer pipette, and the vial is inverted five times for mixing. At the instruction of the reader (LCD read-out), three drops of blood mixture are applied to a well in the cartridge: the reactions then proceed automatically. There are no further procedural steps, and results in %A1C are displayed on the reader's LCD screen in approximately three minutes. The concentration of A1C is expressed as a percentage of the total hemoglobin as follows: %HBA1C = (HBA1C ÷ TOTAL HB) ×100