Electronic Code of Federal Regulations
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e-CFR data is current as of October 22, 2020 |
Title 21 → Chapter I → Subchapter H → Part 866 → Subpart G → §866.6010 |
Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart G—Tumor Associated Antigen immunological Test Systems
§866.6010 Tumor-associated antigen immunological test system.
(a) Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.
(b) Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
[62 FR 66005, Dec. 17, 1997]