Cleared Traditional

CALPREST (K130945) - FDA 510(k) Clearance

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

K130945 · Eurospital S.P.A. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
287d
Days
Class 2
Risk

K130945 is an FDA 510(k) clearance for the CALPREST. Classified as Calprotectin, Fecal (product code NXO), Class II - Special Controls.

Submitted by Eurospital S.P.A. (Woodstock, US). The FDA issued a Cleared decision on January 16, 2014 after a review of 287 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. 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 Eurospital S.P.A. devices

Submission Details

510(k) Number K130945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2013
Decision Date January 16, 2014
Days to Decision 287 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
183d slower than avg
Panel avg: 104d · This submission: 287d
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 Peers - NXO Calprotectin, Fecal

All 14
Devices cleared under the same product code (NXO) and FDA review panel - the closest regulatory comparables to K130945.
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LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
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ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device
K191807 · ALPCO · Oct 2019
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K191718 · Buhlmann Laboratories AG · Sep 2019
Calprest, EasyCal
K191589 · Eurospital S.P.A. · Jul 2019