DeviceClearance

Product code PHF— Immunology

ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT

Classification name
Zinc Transporter 8 Auto-Antibody
Device class
Class 2
Regulation
21 CFR 866.5670
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PHF under 21 CFR 866.5670, via openFDA

Market context for product code PHF

FDA has cleared 1 device under product code PHF, all in 2014, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PHF

Recent clearances under product code PHF

Data sourced from openFDA. This site is unofficial and independent of the FDA.