title: Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format. Final order.
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).
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D005947:Glucose / Q000032:analysis*; D006029:Glycosuria / Q000175:diagnosis*; D006801:Humans; D011933:Reagent Kits, Diagnostic / Q000145:classification*; D014481:United States; D016482:Urinalysis / Q000295:instrumentation
chemical_list: D011933:Reagent Kits, Diagnostic; D005947:Glucose