21 CFR 866.6020 — System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Immunology (IM) · Part 866 Subpart G—Tumor Associated Antigen Immunological Test Systems · § 866.6020
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NQI | System, Immunomagnetic, Circulating Cancer Cell, Enumeration | 2 | 13 |
Special Controls
NQI — System, Immunomagnetic, Circulating Cancer Cell, Enumeration
*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.
eCFR
NQI — System, Immunomagnetic, Circulating Cancer Cell, Enumeration
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.
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