NXO · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5180
Classification
FDA Product Code
NXO
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.5180
Review panel
IM
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
Definition
The device is used for the measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The device can be used as an aid in the diagnosis of inflammatory bowel disease (ibd), crohn's disease and ulcerative colitis and to differentiate ibd from irritable bowel syndrome.