Cleared Traditional

CALPREST

K130945 · Eurospital S.P.A. · Immunology

Jan 2014

Decision

287d

Days

Class 2

Risk

About This 510(k) Submission

K130945 is an FDA 510(k) clearance for the CALPREST, a Calprotectin, Fecal (Class II — Special Controls, product code NXO), submitted by Eurospital S.P.A. (Woodstock, US). The FDA issued a Cleared decision on January 16, 2014, 287 days after receiving the submission on April 4, 2013. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5180.

Submission Details

510(k) Number	K130945 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 04, 2013
Decision Date	January 16, 2014
Days to Decision	287 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.