# DEN140001: Zinc Transporter 8 Antibody (ZNT8AB) Elisa Assay Kit

- Pathway: De Novo (Post-NSE)
- Applicant: Kronus Market Development Associates, Inc.
- Decided: Aug 20, 2014 after 65 days
- Product code: PHF (Zinc Transporter 8 Auto-Antibody)
- Device class: 2
- Regulation: 21 CFR 866.5670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay is for the semi-quantitative determination of autoantibodies to Zinc Transporter 8 (ZnT8) in human serum. The KRONUS 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.

Source page: https://510kreport.com/device/DEN140001
Methodology: https://510kreport.com/methodology