510(k) K170993
K170993 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer". The FDA issued a decision of Substantially Equivalent on December 22, 2017. The device falls under product code NXO (Calprotectin, Fecal), a Class II device regulated under 21 CFR 866.5180. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2017
- Date Received
- April 3, 2017
- 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.