510(k) DEN060001
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 26, 2006
- Date Received
- March 23, 2006
- Clearance Type
- Post-NSE
- 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.