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The Evolution of Accuracy Requirements for Glucose Meters: How We Got to the Recent Food and Drug Administration Draft Guidances

Scott, Mitchell G. PhD

Point of Care: The Journal of Near-Patient Testing & Technology:
doi: 10.1097/POC.0000000000000025
Editorials
Abstract

Abstract: The 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 the strip with water, placing a blood sample on the stick for 50 seconds, washing with water again, blotting with a cotton ball, and then placing the strip into the meter that had a swinging needle indicator of the glucose concentration.1 Moreover, we worry about user error today. The initial meters were marketed to physician offices in the early 1970s, but eventually, patients began to advocate self-use, and the glucose meter industry was born. In the late 1970s and early 1980s, companies such as Boehringer-Mannheim (now Roche), Lifescan (J&J), Medisense (now Abbott), and Bayer also introduced meters. These companies continue to dominate the market and are often referred to as the “branded” meters. Before 1976, there was no premarket regulatory oversight of most medical devices, including glucose meters, in the United States. This changed with the Medical Device Amendment Act passed by the US Congress on May 28, 1976.

Author Information

From the Division of Laboratory and Genomic Medicine, Department of Pathology and Immunology, Washington University School of Medicine, St Louis, MO.

Reprints: Mitchell G. Scott, PhD, Division of Laboratory and Genomic Medicine, Washington University School of Medicine, 660 S Euclid Ave, Campus Box 8118, St Louis, MO 63110. E-mail: mscott@pathology.wustl.edu.

The author declares no conflict of interest.

© 2014 by Lippincott Williams & Wilkins