Calprotectin, Fecal
FDA product code NXO · Class II (moderate risk) · 21 CFR 866.5180 · Immunology
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.
14510(k) clearances
0PMA approvals
3recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232057 | BÜHLMANN fCAL® turbo and CALEX® CapNXO · Special | Bühlmann Laboratories AG | 02/06/2024SE |
| K220763 | ALPCO Calprotectin Immunoturbidimetric AssayNXO · Traditional | Alpco | 04/13/2023SE |
| K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusNXO · Traditional | DiaSorin, Inc. | 07/26/2022SE |
| K191807 | ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction DeviceNXO · Traditional | Alpco | 10/25/2019SE |
| K191718 | Buhlmann fCAL turbo and CALEX CapNXO · Traditional | Buhlmann Laboratories AG | 09/24/2019SE |
| K191592 | CalprestNG, EasyCalNXO · Special | Eurospital S.P.A. | 07/10/2019SE |
| K191589 | Calprest, EasyCalNXO · Special | Eurospital S.P.A. | 07/10/2019SE |
| K190784 | BUHLMANN fCAL turboNXO · Traditional | Buhlmann Laboratories AG | 06/25/2019SE |
| K182698 | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration…NXO · Traditional | DiaSorin, Inc. | 12/26/2018SE |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction DeviceNXO · Traditional | Inova Diagnostics, Inc. | 10/16/2018SE |
| K181012 | BUHLMANN fCAL ELISANXO · Traditional | Buhlmann Laboratories AG | 06/04/2018SE |
| K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash…NXO · Traditional | Inova Diagnostics, Inc. | 12/22/2017SE |
| K160447 | Calprest NGNXO · Traditional | Eurospital S.P.A. | 11/10/2016SE |
| K130945 | CalprestNXO · Traditional | Eurospital S.P.A. | 01/16/2014SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0787-2026 Class II | Leaky Gut TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0784-2026 Class II | IBS TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0677-2025 Class II | DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation…Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's… | Diasorin Inc. | 11/07/2024Open, Classified |