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# Class 2 for Zinc Transporter 8 Autoantibody Immunological Test
- URL: https://www.fdaweb.com/class-2-for-zinc-transporter-8-autoantibody-immunological-test/
- Published: 2017-10-25T12:00:00.000Z
- Updated: 2026-09-14T22:57:59.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139968

*Federal Register* notice: FDA has classified zinc transporter 8 autoantibody immunological test systems into Class 2 (special controls). The classification decision was requested in a 2014 *de novo* request by Kronus Market Development Associates for its Kronus Zinc Transporter 8 Autoantibody ELISA Assay. The agency identifies the classification as a device that consists of reagents used to measure, by immunochemical techniques, the autoantibodies in human serum samples that react with the Zinc Transporter 8\. The measurements aid in diagnosing Type 1 diabetes mellitus (autoimmune mediated diabetes) in conjunction with other clinical and laboratory findings. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-10-24/pdf/2017-22995.pdf?ref=fdaweb.com).