Cleared Special

B?HLMANN fCAL? turbo and CALEX? Cap

K232057 · B?hlmann Laboratories AG · Immunology

Feb 2024

Decision

210d

Days

Class 2

Risk

About This 510(k) Submission

K232057 is an FDA 510(k) clearance for the B?HLMANN fCAL? turbo and CALEX? Cap, a Calprotectin, Fecal (Class II — Special Controls, product code NXO), submitted by B?hlmann Laboratories AG (Sch?nenbuch, CH). The FDA issued a Cleared decision on February 6, 2024, 210 days after receiving the submission on July 11, 2023. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5180.

Submission Details

510(k) Number	K232057 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 2023
Decision Date	February 06, 2024
Days to Decision	210 days
Submission Type	Special
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.