Zinc Transporter 8 Auto-Antibody
The Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay is a semi-quantitative immunoassay for the determination of autoantibodies to Zinc Transporter 8 in human serum, used as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune-mediated diabetes) in conjunction with other clinical and laboratory findings. It is an FDA Class 2 device regulated under 21 CFR 866.5670, requiring 510(k) premarket notification, within the Immunology (IM) specialty. The product code is PHF, and it is eligible for third-party review. The assay is not intended to be used as a standalone diagnostic tool.
Basic Information
- Product Code
- PHF
- Device Class
- FDA class 2
- Regulation Number
- 866.5670
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN140001 | ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT | Aug 20, 2014 | Unknown | Kronus Market Development Associates, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.