21 CFR § 866.5180 - Fecal calprotectin immunological test system.

---
identifier: "/us/cfr/t21/s866.5180"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.5180 - Fecal calprotectin immunological test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.5180"
section_name: "Fecal calprotectin immunological test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "866"
part_name: "IMMUNOLOGY AND MICROBIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "47 FR 50823, Nov. 9, 1982, unless otherwise noted."
cfr_part: "866"
---


# 866.5180 Fecal calprotectin immunological test system.

(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 for*in 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).

[71 FR 42598, July 27, 2006]