Cleared Special

K191589 - Calprest, EasyCal

K191589 is an FDA 510(k) clearance for Calprest, manufactured by Eurospital S.P.A.. The device is a Class 2 Immunology device with product code NXO cleared through the Special 510(k) pathway after a 26-day FDA review.

K191589 · Eurospital S.P.A. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
26d
Days
Class 2
Risk

K191589 is an FDA 510(k) clearance for the Calprest, 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.

FDA 510(k) Submission Details - K191589

510(k) Number K191589 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
79d faster than avg
Panel avg: 105d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

NXO Device Classification - Class 2, Special Controls

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 K191589.
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
CalprestNG, EasyCal
K191592 · Eurospital S.P.A. · Jul 2019
BUHLMANN fCAL turbo
K190784 · Buhlmann Laboratories AG · Jun 2019
LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device
K182698 · DiaSorin, Inc. · Dec 2018
K191589 · Calprest, EasyCal
Download PDF FDA Summary Eurospital S.P.A.