§ 862.1325 21 CFR Ch. I (4–1–12 Edition)

patients with peptic ulcer, Zollinger- cluding diabetes mellitus, hypo- Ellison syndrome (peptic ulcer due to glycemia, and hyperglycemia. gastrin-secreting tumor of the pan- (b) Classification. Class I (general con- creas), and related gastric disorders. trols). The device is exempt from the (b) Classification. Class I (general con- premarket notification procedures in trols). The device is exempt from the subpart E of part 807 of this chapter premarket notification procedures in subject to § 862.9. subpart E of part 807 of this chapter subject to the limitations in § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787, July 25, § 862.1340 Urinary glucose (non- 2001] quantitative) test system. (a) Identification. A urinary glucose § 862.1325 Gastrin test system. (nonquantitative) test system is a de- (a) Identification. A gastrin test sys- vice intended to measure glucosuria tem is a device intended to measure (glucose in urine). Urinary glucose the hormone gastrin in plasma and (nonquantitative) measurements are serum. Measurements of gastrin are used in the diagnosis and treatment of used in the diagnosis and treatment of carbohydrate metabolism disorders in- patients with ulcers, pernicious ane- cluding diabetes mellitus, hypo- mia, and the Zollinger-Ellison syn- glycemia, and hyperglycemia. drome (peptic ulcer due to a gastrin-se- (b) Classification. Class II. creting tumor of the pancreas). (b) Classification. Class I (general con- § 862.1345 Glucose test system. trols). The device is exempt from the premarket notification procedures in (a) Identification. A glucose test sys- subpart E of part 807 of this chapter tem is a device intended to measure subject to § 862.9. glucose quantitatively in blood and other body fluids. Glucose measure- [52 FR 16122, May 1, 1987, as amended at 65 ments are used in the diagnosis and FR 2306, Jan. 14, 2000] treatment of carbohydrate metabolism disorders including diabetes mellitus, § 862.1330 Globulin test system. neonatal hypoglycemia, and idiopathic (a) Identification. A globulin test sys- hypoglycemia, and of pancreatic islet tem is a device intended to measure cell carcinoma. globulins (proteins) in plasma and (b) Classification. Class II. serum. Measurements of globulin are used in the diagnosis and treatment of § 862.1360 Gamma-glutamyl patients with numerous illnesses in- transpeptidase and isoenzymes test cluding severe liver and renal disease, system. multiple myeloma, and other disorders (a) Identification. A gamma-glutamyl of blood globulins. transpeptidase and isoenzymes test (b) Classification. Class I (general con- system is a device intended to measure trols). The device is exempt from the the activity of the enzyme gamma- premarket notification procedures in glutamyl transpeptidase (GGTP) in subpart E of part 807 of this chapter plasma and serum. Gamma-glutamyl subject to § 862.9. transpeptidase and isoenzymes meas- [52 FR 16122, May 1, 1987, as amended at 65 urements are used in the diagnosis and FR 2306, Jan. 14, 2000] treatment of liver diseases such as al- coholic cirrhosis and primary and sec- § 862.1335 Glucagon test system. ondary liver tumors. (a) Identification. A glucagon test sys- (b) Classification. Class I (general con- tem is a device intended to measure trols). The device is exempt from the the pancreatic hormone glucagon in premarket notification procedures in plasma and serum. Glucagon measure- subpart E of part 807 of this chapter ments are used in the diagnosis and subject to § 862.9. treatment of patients with various dis- [52 FR 16122, May 1, 1987, as amended at 65 orders of carbohydrate metabolism, in- FR 2306, Jan. 14, 2000]

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