K191718 is an FDA 510(k) clearance for the Buhlmann fCAL turbo and CALEX Cap. This device is classified as a Calprotectin, Fecal (Class II - Special Controls, product code NXO).
Submitted by Buhlmann Laboratories AG (Schönenbuch, CH). The FDA issued a Cleared decision on September 24, 2019, 90 days after receiving the submission on June 26, 2019.
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 | K191718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2019 |
| Decision Date | September 24, 2019 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| 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. |