Calprotectin, Fecal
The Calprotectin, Fecal device (product code NXO) is an in vitro diagnostic immunoassay used to measure fecal calprotectin, a neutrophilic protein marker of mucosal inflammation, in human stool samples, aiding in the diagnosis of inflammatory bowel disease (IBD), Crohn's disease, and ulcerative colitis, and helping differentiate IBD from irritable bowel syndrome. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 866.5180 within the Immunology specialty. Third-party 510(k) review is available for this device type.
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Basic Information
- Product Code
- NXO
- Device Class
- FDA class 2
- Regulation Number
- 866.5180
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K232057 | BÜHLMANN fCAL® turbo and CALEX® Cap | Feb 06, 2024 | Substantially Equivalent | Bühlmann Laboratories AG |
| K220763 | ALPCO Calprotectin Immunoturbidimetric Assay | Apr 13, 2023 | Substantially Equivalent | ALPCO |
| K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus | Jul 26, 2022 | Substantially Equivalent | DiaSorin, Inc. |
| K191807 | ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device | Oct 25, 2019 | Substantially Equivalent | ALPCO |
| K191718 | Buhlmann fCAL turbo and CALEX Cap | Sep 24, 2019 | Substantially Equivalent | Buhlmann Laboratories AG |
| K191592 | CalprestNG, EasyCal | Jul 10, 2019 | Substantially Equivalent | Eurospital S.P.A. |
| K191589 | Calprest, EasyCal | Jul 10, 2019 | Substantially Equivalent | Eurospital S.P.A. |
| K190784 | BUHLMANN fCAL turbo | Jun 25, 2019 | Substantially Equivalent | Buhlmann Laboratories AG |
| K182698 | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device | Dec 26, 2018 | Substantially Equivalent | DiaSorin, Inc. |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction Device | Oct 16, 2018 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K181012 | BUHLMANN fCAL ELISA | Jun 04, 2018 | Substantially Equivalent | Buhlmann Laboratories AG |
| K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer | Dec 22, 2017 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K160447 | Calprest NG | Nov 10, 2016 | Substantially Equivalent | Eurospital S.P.A. |
| K130945 | CALPREST | Jan 16, 2014 | Substantially Equivalent | Eurospital S.P.A. |
| DEN060001 | PHICAL TEST | Apr 26, 2006 | Unknown | Genova Diagnostics |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.