Cleared Traditional

ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device

K191807 · ALPCO · Immunology

Oct 2019

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K191807 is an FDA 510(k) clearance for the ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device, a Calprotectin, Fecal (Class II — Special Controls, product code NXO), submitted by ALPCO (Salem, US). The FDA issued a Cleared decision on October 25, 2019, 112 days after receiving the submission on July 5, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5180.

Submission Details

510(k) Number	K191807 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 05, 2019
Decision Date	October 25, 2019
Days to Decision	112 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.