NXO

Calprotectin, Fecal

Product code

NXO

Device name

Calprotectin, Fecal

Device class

Class 2

21 CFR

21 CFR 866.5180

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

15 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-02-06.

1 summaries are archived here for direct download.