Cleared Special

CalprestNG, EasyCal (K191592) - FDA 510(k) Clearance

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

K191592 · Eurospital S.P.A. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
26d
Days
Class 2
Risk

K191592 is an FDA 510(k) clearance for the CalprestNG, EasyCal. Classified as Calprotectin, Fecal (product code NXO), Class II - Special Controls.

Submitted by Eurospital S.P.A. (Trieste, IT). The FDA issued a Cleared decision on July 10, 2019 after a review of 26 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Eurospital S.P.A. devices

Submission Details

510(k) Number K191592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2019
Decision Date July 10, 2019
Days to Decision 26 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
78d faster than avg
Panel avg: 104d · This submission: 26d
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 Peers - NXO Calprotectin, Fecal

All 14
Devices cleared under the same product code (NXO) and FDA review panel - the closest regulatory comparables to K191592.
BÜHLMANN fCAL® turbo and CALEX® Cap
K232057 · B?hlmann Laboratories AG · Feb 2024
ALPCO Calprotectin Immunoturbidimetric Assay
K220763 · ALPCO · Apr 2023
LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
K213858 · DiaSorin, Inc. · Jul 2022
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