21 CFR § 864.5800 - Automated sedimentation rate device.
---
identifier: "/us/cfr/t21/s864.5800"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.5800 - Automated sedimentation rate device."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.5800"
section_name: "Automated sedimentation rate 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"
---
# 864.5800 Automated sedimentation rate device.
(a) *Identification.* An automated sedimentation rate device is an instrument that measures automatically the erythrocyte sedimentation rate in whole blood. Because an increased sedimentation rate indicates tissue damage or inflammation, the erythrocyte sedimentation rate device is useful in monitoring treatment of a disease.
(b) *Classification.* Class I (general controls). This 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 60602, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790, July 25, 2001]