---
kind: "section"
citation: "21 C.F.R. § 866.6020"
title: "21"
number: "866.6020"
heading: "Immunomagnetic circulating cancer cell selection and enumeration system."
url: "https://uscodex.org/cfr/21/866.6020"
---

# §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)](/cfr/21/866.1.md?p=e) for availability of this guidance document.

## Notes

### Amendments

[69 FR 26038, May 11, 2004]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 47 FR 50823, Nov. 9, 1982, unless otherwise noted.

### Amendments

[69 FR 26038, May 11, 2004]