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NXO — Calprotectin, Fecal Class II

FDA Device Classification

FDA product code NXO covers "Calprotectin, Fecal", a Class II medical device regulated under 21 CFR 866.5180. Submissions are reviewed by the Immunology panel. At least 15 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
NXO
Device Class
Class II
Regulation Number
866.5180
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232057bühlmann laboratoriesBÜHLMANN fCAL® turbo and CALEX® CapFebruary 6, 2024
K220763alpcoALPCO Calprotectin Immunoturbidimetric AssayApril 13, 2023
K213858diasorinLIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusJuly 26, 2022
K191807alpcoALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction DeviceOctober 25, 2019
K191718buhlmann laboratoriesBuhlmann fCAL turbo and CALEX CapSeptember 24, 2019
K191592eurospitalCalprestNG, EasyCalJuly 10, 2019
K191589eurospitalCalprest, EasyCalJuly 10, 2019
K190784buhlmann laboratoriesBUHLMANN fCAL turboJune 25, 2019
K182698diasorinLIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin CalDecember 26, 2018
K180971inova diagnosticsQUANTA Flash Calprotectin and Fecal Extraction DeviceOctober 16, 2018
K181012buhlmann laboratoriesBUHLMANN fCAL ELISAJune 4, 2018
K170993inova diagnosticsQUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTDecember 22, 2017
K160447eurospitalCalprest NGNovember 10, 2016
K130945eurospitalCALPRESTJanuary 16, 2014
DEN060001genova diagnosticsPHICAL TESTApril 26, 2006

FDA data resources