21 CFR § 866.5420 - -1-glycoproteins immunological test system.
---
identifier: "/us/cfr/t21/s866.5420"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.5420 - -1-glycoproteins immunological test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.5420"
section_name: "-1-glycoproteins immunological test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "866"
part_name: "IMMUNOLOGY AND MICROBIOLOGY 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."
regulatory_source: "47 FR 50823, Nov. 9, 1982, unless otherwise noted."
cfr_part: "866"
---
# 866.5420 -1-glycoproteins immunological test system.
(a) *Identification.* An *alpha-*1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques *alpha-*1-glycoproteins (a group of plasma proteins found in the *alpha-*1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specific *alpha-*1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.
(b) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]