510(k) K191807
K191807 is an FDA 510(k) premarket notification submitted by ALPCO for the device "ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device". The FDA issued a decision of Substantially Equivalent on October 25, 2019. The device falls under product code NXO (Calprotectin, Fecal), a Class II device regulated under 21 CFR 866.5180. ALPCO has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 2019
- Date Received
- July 5, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calprotectin, Fecal
- Device Class
- Class II
- Regulation Number
- 866.5180
- Review Panel
- IM
- Submission Type
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.