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e-CFR data is current as of April 15, 2021

Title 21Chapter ISubchapter HPart 862Subpart B → §862.1720


Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems


§862.1720   Triose phosphate isomerase test system.

(a) Identification. A triose phosphate isomerase test system is a device intended to measure the activity of the enzyme triose phosphate isomerase in erythrocytes (red blood cells). Triose phosphate isomerase is an enzyme important in glycolysis (the energy-yielding conversion of glucose to lactic acid in various tissues). Measurements obtained by this device are used in the diagnosis and treatment of congenital triose phosphate isomerase enzyme deficiency, which causes a type of hemolytic anemia.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 subject to the limitations in §862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001]

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