Cleared Special

Calprest, EasyCal

K191589 · Eurospital S.P.A. · Immunology

Jul 2019

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K191589 is an FDA 510(k) clearance for the Calprest, EasyCal, 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 July 10, 2019, 26 days after receiving the submission on June 14, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5180.

Submission Details

510(k) Number	K191589 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 14, 2019
Decision Date	July 10, 2019
Days to Decision	26 days
Submission Type	Special
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.