21 CFR 866.6020
§ 866.6020 Immunomagnetic circulating cancer cell selection and enumeration system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 866.6020, § 866.6020 Immunomagnetic circulating cancer cell selection and enumeration system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89691
- Permanent ID
ys:prov:89691@1- SHA-256
97221c8d1fe63bbce8fd51df3d2092a919b32899b694d0f58455218849812808
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.