21 CFR § 864.7100 - Red blood cell enzyme assay.

---
identifier: "/us/cfr/t21/s864.7100"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.7100 - Red blood cell enzyme assay."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.7100"
section_name: "Red blood cell enzyme 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"
---


# 864.7100 Red blood cell enzyme assay.

(a) *Identification.* Red blood cell enzyme assay is a device used to measure the activity in red blood cells of clinically important enzymatic reactions and their products, such as pyruvate kinase or 2,3-diphosphoglycerate. A red blood cell enzyme assay is used to determine the enzyme defects responsible for a patient's hereditary hemolytic anemia.

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

[45 FR 60610, Sept. 12, 1980]