21 CFR § 864.5680 - Automated heparin analyzer.

---
identifier: "/us/cfr/t21/s864.5680"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.5680 - Automated heparin analyzer."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.5680"
section_name: "Automated heparin analyzer."
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"
---


# 864.5680 Automated heparin analyzer.

(a) *Identification.* An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.

(b) *Classification.* Class II (special controls).

[45 FR 60601, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 58 FR 51571, Oct. 4, 1993]