Cleared Traditional

BUHLMANN fCAL ELISA (K181012) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181012 · Buhlmann Laboratories AG · Immunology device
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Jun 2018
Decision
48d
Days
Class 2
Risk

K181012 is an FDA 510(k) clearance for the BUHLMANN fCAL ELISA. Classified as Calprotectin, Fecal (product code NXO), Class II - Special Controls.

Submitted by Buhlmann Laboratories AG (Schonenbuch, CH). The FDA issued a Cleared decision on June 4, 2018 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5180 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Buhlmann Laboratories AG devices

Submission Details

510(k) Number K181012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2018
Decision Date June 04, 2018
Days to Decision 48 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 104d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NXO Calprotectin, Fecal
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Consultant

Mapi Srs, an Icon Plc Company
Roshana Ahmed

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NXO Calprotectin, Fecal

All 14
Devices cleared under the same product code (NXO) and FDA review panel - the closest regulatory comparables to K181012.
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ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device
K191807 · ALPCO · Oct 2019
Buhlmann fCAL turbo and CALEX Cap
K191718 · Buhlmann Laboratories AG · Sep 2019
Calprest, EasyCal
K191589 · Eurospital S.P.A. · Jul 2019