DeviceClearance

Product code NXO— Immunology

ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device

Classification name
Calprotectin, Fecal
Device class
Class 2
Regulation
21 CFR 866.5180
Advisory panel
Immunology
Total cleared
15
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code NXO under 21 CFR 866.5180, via openFDA

Market context for product code NXO

FDA has cleared 15 devices under product code NXO between 2006 and 2024, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NXO

Recent clearances under product code NXO

Data sourced from openFDA. This site is unofficial and independent of the FDA.