510(k) DEN140001

ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT by Kronus Market Development Associates, Inc. — Product Code PHF

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.

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