Cleared Traditional

K190784 - BUHLMANN fCAL turbo

K190784 is the FDA 510(k) clearance for BUHLMANN fCAL turbo by Buhlmann Laboratories AG. It is a Class 2 Immunology device (product code NXO) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K190784 · Buhlmann Laboratories AG · Immunology device
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Jun 2019
Decision
90d
Days
Class 2
Risk

K190784 is an FDA 510(k) clearance for the BUHLMANN fCAL turbo. Classified as Calprotectin, Fecal (product code NXO), Class II - Special Controls.

Submitted by Buhlmann Laboratories AG (Schönenbuch, CH). The FDA issued a Cleared decision on June 25, 2019 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Buhlmann Laboratories AG devices

Submission Details

510(k) Number K190784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2019
Decision Date June 25, 2019
Days to Decision 90 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
14d faster than avg
Panel avg: 104d · This submission: 90d
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

QUARAS, LLC
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 11
Devices cleared under the same product code (NXO) and FDA review panel - the closest regulatory comparables to K190784.
Buhlmann fCAL turbo and CALEX Cap
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CalprestNG, EasyCal
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K182698 · DiaSorin, Inc. · Dec 2018
QUANTA Flash Calprotectin and Fecal Extraction Device
K180971 · Inova Diagnostics, Inc. · Oct 2018
BUHLMANN fCAL ELISA
K181012 · Buhlmann Laboratories AG · Jun 2018