21 CFR § 864.5300 - Red cell indices device.

---
identifier: "/us/cfr/t21/s864.5300"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.5300 - Red cell indices device."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.5300"
section_name: "Red cell indices device."
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"
---


# 864.5300 Red cell indices device.

(a) *Identification.* A red cell indices device, usually part of a larger system, calculates or directly measures the erythrocyte mean corpuscular volume (MCV), the mean corpuscular hemoglobin (MCH), and the mean corpuscular hemoglobin concentration (MCHC). The red cell indices are used for the differential diagnosis of anemias.

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

[45 FR 60597, Sept. 12, 1980]