Cleared Traditional

K220763 - ALPCO Calprotectin Immunoturbidimetric Assay
(FDA 510(k) Clearance)

K220763 · ALPCO · Immunology

Apr 2023

Decision

393d

Days

Class 2

Risk

K220763 is an FDA 510(k) clearance for the ALPCO Calprotectin Immunoturbidimetric Assay, a Calprotectin, Fecal (Class II — Special Controls, product code NXO), submitted by ALPCO (Salem, US). The FDA issued a Cleared decision on April 13, 2023, 393 days after receiving the submission on March 16, 2022. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5180.

Submission Details

510(k) Number	K220763 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 16, 2022
Decision Date	April 13, 2023
Days to Decision	393 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

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.