Cleared Traditional

LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus

K213858 · DiaSorin, Inc. · Immunology

Jul 2022

Decision

228d

Days

Class 2

Risk

About This 510(k) Submission

K213858 is an FDA 510(k) clearance for the LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus, a Calprotectin, Fecal (Class II — Special Controls, product code NXO), submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on July 26, 2022, 228 days after receiving the submission on December 10, 2021. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5180.

Submission Details

510(k) Number	K213858 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 10, 2021
Decision Date	July 26, 2022
Days to Decision	228 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.