CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR866.6020]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 866 -- IMMUNOLOGY AND MICROBIOLOGY DEVICES

Subpart G - Tumor Associated Antigen immunological Test Systems

Sec. 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]