| | Guidance Glucose Document |
 | | DEFINITION: Portable blood glucose devices are intended for use in hospitals, at point of care, in physicians' offices, and over-the-counter as in vitro diagnostic tests for quantitative and semi-quantitative measurement of glucose by glucose oxidase, dehydrogenase, or hexokinase based methodologies. |
 | | Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell tumors. |
 | | These monitors quantify glucose amperometrically by measuring the current that is produced when glucose oxidase catalyzes the oxidation of glucose to gluconic acid or when glucose dehydrogenase catalyzes the oxidation of glucose to gluconolactone. |
| www.fda.gov /cdrh/ode/gluc.html (4663 words) |