Cleared Traditional

Buhlmann fCAL turbo and CALEX Cap

K191718 · Buhlmann Laboratories AG · Immunology

Sep 2019

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K191718 is an FDA 510(k) clearance for the Buhlmann fCAL turbo and CALEX Cap, a Calprotectin, Fecal (Class II — Special Controls, product code NXO), submitted by Buhlmann Laboratories AG (Sch?nenbuch, CH). The FDA issued a Cleared decision on September 24, 2019, 90 days after receiving the submission on June 26, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5180.

Submission Details

510(k) Number	K191718 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 2019
Decision Date	September 24, 2019
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.