Journal: Federal register
Article Title: Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format. Final order.
PMID/MRN: 27731614
Publication Date: 2016-Oct-04
Abstract:
The Food and Drug Administration (FDA) is publishing an order denying a petition requesting exemption from the premarket notification
requirements for "method, metallic reduction, glucose (urinary, nonquantitative)'' devices that are in a reagent tablet format and are
classified as class II devices as urinary glucose (nonquantitative) test system (hereinafter referred to as copper reduction tablet
test"). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including
diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this order in accordance with procedures established by the Food and
Drug Administration Modernization Act of 1997 (FDAMA).