NXOClass II

Calprotectin, Fecal

21 CFR 866.5180 / Immunology

NXO is the FDA product code for Calprotectin, Fecal, a class II device type, regulated under 21 CFR 866.5180. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 15 510(k) clearances under this code, the most recent dated 2024-02-06, and 3 recalls.

Classification record

Product code: NXO
Device name: Calprotectin, Fecal
FDA 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.
Regulation: 21 CFR 866.5180
Device class: Class II
Review panel: Immunology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 15
Ingested recalls: 3

Clearances, product code NXO

By decision year

15 clearances under product code NXO with a decision year between 2006 and 2024, 2019 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code NXO by decision year
Year	Clearances
2006	1
2014	1
2016	1
2017	1
2018	3
2019	5
2022	1
2023	1
2024	1

Applicants with the most clearances

Product code NXO

Applicants holding the most 510(k) clearances under product code NXO
Applicant	Clearances
Buhlmann Laboratories AG	4
Eurospital S.p.A.	4
Alpco	2
Diasorin Inc.	2
Inova Diagnostics, Inc.	2
Genova Diagnostics	1

Companies listing this code with FDA

Companies whose registered establishments list this code