21 CFR § 866.6030 - AFP-L3% immunological test system.

---
identifier: "/us/cfr/t21/s866.6030"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.6030 - AFP-L3% immunological test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.6030"
section_name: "AFP-L3% 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"
---


# 866.6030 AFP-L3% immunological test system.

(a) *Identification.* An AFP-L3% immunological test system is an in vitro device that consists of reagents and an automated instrument used to quantitatively measure, by immunochemical techniques, AFP and AFP-L3 subfraction in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma, in conjunction with other laboratory findings, imaging studies, and clinical assessment.

(b) *Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: AFP-L3% Immunological Test Systems.” See § 866.1(e) for the availability of this guidance document.

[70 FR 57749, Oct. 4, 2005]