510(k) K191592
K191592 is an FDA 510(k) premarket notification submitted by Eurospital S.P.A. for the device "CalprestNG, EasyCal". The FDA issued a decision of Substantially Equivalent on July 10, 2019. The device falls under product code NXO (Calprotectin, Fecal), a Class II device regulated under 21 CFR 866.5180. Eurospital S.P.A. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 2019
- Date Received
- June 14, 2019
- Clearance Type
- Special
- 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.