PHF — Zinc Transporter 8 Auto-Antibody Class II
Classification Details
- Product Code
- PHF
- Device Class
- Class II
- Regulation Number
- 866.5670
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN140001 | kronus market development associates | ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT | August 20, 2014 |