NXO — Calprotectin, Fecal Class II
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232057 | bühlmann laboratories | BÜHLMANN fCAL® turbo and CALEX® Cap | February 6, 2024 |
| K220763 | alpco | ALPCO Calprotectin Immunoturbidimetric Assay | April 13, 2023 |
| K213858 | diasorin | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus | July 26, 2022 |
| K191807 | alpco | ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device | October 25, 2019 |
| K191718 | buhlmann laboratories | Buhlmann fCAL turbo and CALEX Cap | September 24, 2019 |
| K191589 | eurospital | Calprest, EasyCal | July 10, 2019 |
| K191592 | eurospital | CalprestNG, EasyCal | July 10, 2019 |
| K190784 | buhlmann laboratories | BUHLMANN fCAL turbo | June 25, 2019 |
| K182698 | diasorin | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Cal | December 26, 2018 |
| K180971 | inova diagnostics | QUANTA Flash Calprotectin and Fecal Extraction Device | October 16, 2018 |
| K181012 | buhlmann laboratories | BUHLMANN fCAL ELISA | June 4, 2018 |
| K170993 | inova diagnostics | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANT | December 22, 2017 |
| K160447 | eurospital | Calprest NG | November 10, 2016 |
| K130945 | eurospital | CALPREST | January 16, 2014 |
| DEN060001 | genova diagnostics | PHICAL TEST | April 26, 2006 |