Cleared Special

K232057 - BÜHLMANN fCAL® turbo and CALEX® Cap (FDA 510(k) Clearance)

Class II Immunology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K232057 · B?hlmann Laboratories AG · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
210d
Days
Class 2
Risk

K232057 is an FDA 510(k) clearance for the BÜHLMANN fCAL® turbo and CALEX® Cap. Classified as Calprotectin, Fecal (product code NXO), Class II - Special Controls.

Submitted by B?hlmann Laboratories AG (Schönenbuch, CH). The FDA issued a Cleared decision on February 6, 2024 after a review of 210 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5180 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all B?hlmann Laboratories AG devices

Submission Details

510(k) Number K232057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 104d · This submission: 210d
Pathway characteristics
Modification to existing cleared device.

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

QUARAS, LLC
Roshana Ahmed, M.A., RAC

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.