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e-CFR data is current as of July 9, 2020

Title 21Chapter ISubchapter HPart 866Subpart G → §866.6020


Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart G—Tumor Associated Antigen immunological Test Systems


§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]

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