510(k) DEN140001
DEN140001 is an FDA 510(k) premarket notification submitted by Kronus Market Development Associates, Inc. for the device "ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT". The FDA issued a decision of De Novo Granted on August 20, 2014. The device falls under product code PHF (Zinc Transporter 8 Auto-Antibody), a Class II device regulated under 21 CFR 866.5670. Kronus Market Development Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 20, 2014
- Date Received
- June 16, 2014
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Zinc Transporter 8 Auto-Antibody
- Device Class
- Class II
- Regulation Number
- 866.5670
- Review Panel
- IM
- Submission Type
The Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay is for the semi-quantitative determination of autoantibodies to Zinc Transporter 8 (ZnT8) in human serum. The Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The ZnT8Ab assay is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.