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The Evolution of Accuracy Requirements for Glucose Meters: How We Got to the Recent Food and Drug Administration Draft Guidances
AbstractThe initial US patent (patent no. 3,604,815) for a reflectance glucose meter was assigned to Miles Laboratories, Inc, in 1971. This meter was based on the Ames Dextrostix, a dipstick using glucose oxidase and peroxidase to generate a blue color where the intensity was dependent on the glucose concentration. Developed for use in physician offices, the Dextrostix was good enough to distinguish hypoglycemia from hyperglycemia using a color intensity chart and the human eye. The initial Miles Reflectance Meter was designed to quantify color intensity of a Dextrostix using light reflectance. The process involved rinsing...
Source: Point of Care: The Journal of Near-Patient Testing and Technology - September 1, 2014 Category: Pathology Tags: Editorials Source Type: research

Blood Glucose Meters: What is Next?
No abstract available (Source: Point of Care: The Journal of Near-Patient Testing and Technology)
Source: Point of Care: The Journal of Near-Patient Testing and Technology - September 1, 2014 Category: Pathology Tags: Editorials Source Type: research