21 CFR § 866.6020 - Immunomagnetic circulating cancer cell selection and enumeration system.

---
identifier: "/us/cfr/t21/s866.6020"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.6020 - Immunomagnetic circulating cancer cell selection and enumeration system."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.6020"
section_name: "Immunomagnetic circulating cancer cell selection and enumeration 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"
---


# 866.6020 Immunomagnetic circulating cancer cell selection and enumeration system.

(a) *Identification.* An immunomagnetic circulating cancer cell selection and enumeration system is a device that consists of biological probes, fluorochromes, and other reagents; preservation and preparation devices; and a semiautomated analytical instrument to select and count circulating cancer cells in a prepared sample of whole blood. This device is intended for adjunctive use in monitoring or predicting cancer disease progression, response to therapy, and for the detection of recurrent disease.

(b) *Classification.* Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System.” See § 866.1(e) for availability of this guidance document.

[69 FR 26038, May 11, 2004]