K130945 is an FDA 510(k) clearance for the CALPREST. This device is classified as a Calprotectin, Fecal (Class II - Special Controls, product code NXO).
Submitted by Eurospital S.P.A. (Woodstock, US). The FDA issued a Cleared decision on January 16, 2014, 287 days after receiving the submission on April 4, 2013.
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 | K130945 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2013 |
| Decision Date | January 16, 2014 |
| Days to Decision | 287 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. |