K213858 is an FDA 510(k) clearance for the LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus. This device is classified as a Calprotectin, Fecal (Class II - Special Controls, product code NXO).
Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on July 26, 2022, 228 days after receiving the submission on December 10, 2021.
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 | K213858 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2021 |
| Decision Date | July 26, 2022 |
| Days to Decision | 228 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. |