21 CFR § 864.8625 - Hematology quality control mixture.

---
identifier: "/us/cfr/t21/s864.8625"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.8625 - Hematology quality control mixture."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.8625"
section_name: "Hematology quality control mixture."
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"
---


# 864.8625 Hematology quality control mixture.

(a) *Identification.* A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

(b) *Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

[45 FR 60637, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]