K232057 is an FDA 510(k) clearance for the BÜHLMANN fCAL® turbo and CALEX® Cap. This device is classified as a Calprotectin, Fecal (Class II - Special Controls, product code NXO).
Submitted by B?hlmann Laboratories AG (Schönenbuch, CH). The FDA issued a Cleared decision on February 6, 2024, 210 days after receiving the submission on July 11, 2023.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5180. 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) Number | K232057 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2023 |
| Decision Date | February 06, 2024 |
| Days to Decision | 210 days |
| Submission Type | Special |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | NXO - Calprotectin, Fecal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5180 |
| 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. |