21 CFR § 864.5200 - Automated cell counter.

---
identifier: "/us/cfr/t21/s864.5200"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.5200 - Automated cell counter."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.5200"
section_name: "Automated cell counter."
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"
---


# 864.5200 Automated cell counter.

(a) *Identification.* An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.

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

[45 FR 60593, Sept. 12, 1980]