Cleared Traditional

LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device

K182698 · DiaSorin, Inc. · Immunology

Dec 2018

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K182698 is an FDA 510(k) clearance for the LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device, a Calprotectin, Fecal (Class II — Special Controls, product code NXO), submitted by DiaSorin, Inc. (Stillwater,, US). The FDA issued a Cleared decision on December 26, 2018, 90 days after receiving the submission on September 27, 2018. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5180.

Submission Details

510(k) Number	K182698 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2018
Decision Date	December 26, 2018
Days to Decision	90 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.