Cleared Traditional

LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device (K182698) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence.

K182698 · DiaSorin, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
90d
Days
Class 2
Risk

K182698 is an FDA 510(k) clearance for the LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin .... Classified as Calprotectin, Fecal (product code NXO), Class II - Special Controls.

Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on December 26, 2018 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 DiaSorin, Inc. devices

Submission Details

510(k) Number K182698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2018
Decision Date December 26, 2018
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.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Immunology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03143517 Completed Observational Industry-sponsored

Fecal Calprotectin Collection Protocol

CALFE Stool Sample Collection Protocol

240
Patients (actual)
13
Sites
Condition studied Inflammatory Bowel Diseases; Irritable Bowel Syndrome; Ulcerative Colitis; Crohn Disease; Indeterminate Colitis; Chronic Diarrhea; Celiac Disease; Diverticulitis; Abdominal Pain; Distension; Weight Loss; Food Intolerance; Constipation
Eligibility All sexes · 4 Years+
Sponsor DiaSorin Inc. (industry)
Started 2017-04-19 → Primary completion 2018-08-23
Primary outcome
Calprotectin Stool Collection
Study completed - no results published. This trial concluded in 2018 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - NXO Calprotectin, Fecal

All 14
Devices cleared under the same product code (NXO) and FDA review panel - the closest regulatory comparables to K182698.
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