NXO · Calprotectin, Fecal
Immunology · 21 CFR 866.5180 · Class 2
Overview
| Product Code | NXO |
|---|---|
| Device Name | Calprotectin, Fecal |
| Regulation | 21 CFR 866.5180 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A fecal calprotectin immunological test system is an in vitro diagnostic device that consists of reagents used to quantitatively measure, by immunochemical techniques, fecal calprotectin in human stool specimens. The device is intended for in vitro diagnostic use as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically Crohn's disease and ulcerative colitis, and as an aid in differentiation of IBD from irritable bowel syndrome.
Classification Rationale
Class II (special controls). The special control for these devices is FDA's guidance document entitled “Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems.” For the availability of this guidance document, see § 866.1(e).
Special Controls
The device is classified as Class II under regulation 21 CFR 866.5180 with special controls. The special control guidance document, "Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems" will be available shortly.
*Classification.* Class II (special controls). The special control for these devices is FDA's guidance document entitled “Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems.” For the availability of this guidance document, see § 866.1(e).
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232057 | BÜHLMANN fCAL® turbo and CALEX® Cap | Bühlmann Laboratories AG | Feb 6, 2024 | SESE |
| K220763 | ALPCO Calprotectin Immunoturbidimetric Assay | ALPCO | Apr 13, 2023 | SESE |
| K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus | DiaSorin, Inc. | Jul 26, 2022 | SESE |
| K191807 | ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device | ALPCO | Oct 25, 2019 | SESE |
| K191718 | Buhlmann fCAL turbo and CALEX Cap | Buhlmann Laboratories AG | Sep 24, 2019 | SESE |
| K191592 | CalprestNG, EasyCal | Eurospital S.P.A. | Jul 10, 2019 | SESE |
| K191589 | Calprest, EasyCal | Eurospital S.P.A. | Jul 10, 2019 | SESE |
| K190784 | BUHLMANN fCAL turbo | Buhlmann Laboratories AG | Jun 25, 2019 | SESE |
| K182698 | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device | DiaSorin, Inc. | Dec 26, 2018 | SESE |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction Device | Inova Diagnostics, Inc. | Oct 16, 2018 | SESE |
| K181012 | BUHLMANN fCAL ELISA | Buhlmann Laboratories AG | Jun 4, 2018 | SESE |
| K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer | Inova Diagnostics, Inc. | Dec 22, 2017 | SESE |
| K160447 | Calprest NG | Eurospital S.P.A. | Nov 10, 2016 | SESE |
| K130945 | CALPREST | Eurospital S.P.A. | Jan 16, 2014 | SESE |
| DEN060001 | PHICAL TEST | Genova Diagnostics | Apr 26, 2006 | DENG |
Top Applicants
- Eurospital S.P.A. — 4 clearances
- Buhlmann Laboratories AG — 3 clearances
- Inova Diagnostics, Inc. — 2 clearances
- DiaSorin, Inc. — 2 clearances
- ALPCO — 2 clearances
