21 C.F.R. 21 CFR--PART 866
Title 21 - Food and Drugs
Effective Date(s): August 28, 2006 2. Section 866.5180 is added to subpart F to read as follows: (a) Identification. A fecal calprotectin immunological test system is an in vitro diagnostic device that consists of reagents used to quantitatively measure, by immunochemical techniques, fecal calprotectin in human stool specimens. The device is intended forin vitro diagnostic use as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically Crohn's disease and ulcerative colitis, and as an aid in differentiation of IBD from irritable bowel syndrome. (b) Classification. Class II (special controls). The special control for these devices is FDA's guidance document entitled “Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems.” For the availability of this guidance document, see §866.1(e).
Amendment from July 27, 2006
21 CFR--PART 866
Amendment(s) published July 27, 2006, in 71 FR 42598
§ 866.5180 Fecal calprotectin immunological test system.
