K170993 is an FDA 510(k) clearance for the QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer. This device is classified as a Calprotectin, Fecal (Class II - Special Controls, product code NXO).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 22, 2017, 263 days after receiving the submission on April 3, 2017.
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 | K170993 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2017 |
| Decision Date | December 22, 2017 |
| Days to Decision | 263 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. |