21 CFR § 864.5260 - Automated cell-locating device.

---
identifier: "/us/cfr/t21/s864.5260"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.5260 - Automated cell-locating device."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.5260"
section_name: "Automated cell-locating 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"
---


# 864.5260 Automated cell-locating device.

(a) *Identification.* An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)

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

[45 FR 60597, Sept. 12, 1980]