21 CFR § 864.7360 - Erythrocytic glucose-6-phosphate dehydrogenase assay.

---
identifier: "/us/cfr/t21/s864.7360"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.7360 - Erythrocytic glucose-6-phosphate dehydrogenase assay."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.7360"
section_name: "Erythrocytic glucose-6-phosphate dehydrogenase assay."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "864"
part_name: "HEMATOLOGY AND PATHOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
cfr_part: "864"
---


# 864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay.

(a) *Identification.* An erythrocytic glucose-6-phosphate dehydrogenase assay is a device used to measure the activity of the enzyme glucose-6-phosphate dehydrogenase or of glucose-6-phosphate dehydrogenase isoenzymes. The results of this assay are used in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a glucose-6-phosphate dehydrogenase deficiency. This generic device includes assays based on fluorescence, electrophoresis, methemoglobin reduction, catalase inhibition, and ultraviolet kinetics.

(b) *Classification.* Class II (performance standards).

[45 FR 60616, Sept. 12, 1980]