Cleared Traditional

Calprest NG

K160447 · Eurospital S.P.A. · Immunology

Nov 2016

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K160447 is an FDA 510(k) clearance for the Calprest NG, a Calprotectin, Fecal (Class II — Special Controls, product code NXO), submitted by Eurospital S.P.A. (Trieste, IT). The FDA issued a Cleared decision on November 10, 2016, 267 days after receiving the submission on February 17, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5180.

Submission Details

510(k) Number	K160447 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 17, 2016
Decision Date	November 10, 2016
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	NXO — Calprotectin, Fecal
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5180
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.