PHFClass II

Zinc Transporter 8 Auto-Antibody

21 CFR 866.5670 / Immunology

PHF is the FDA product code for Zinc Transporter 8 Auto-Antibody, a class II device type, regulated under 21 CFR 866.5670. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2014-08-20, and no recalls.

Classification record

Product code: PHF
Device name: Zinc Transporter 8 Auto-Antibody
FDA 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.
Regulation: 21 CFR 866.5670
Device class: Class II
Review panel: Immunology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code PHF

By decision year

1 clearance under product code PHF with a decision year between 2014 and 2014, 2014 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code PHF by decision year
Year	Clearances
2014	1

Applicants with the most clearances

Product code PHF

Applicants holding the most 510(k) clearances under product code PHF
Applicant	Clearances
Kronus Market Development Associates, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code PHF

DEN140001Class IIZinc Transporter 8 Antibody (Znt8ab) Elisa Assay KitKronus Market Development Associates, Inc. / cleared 2014-08-20

Recent recalls

Product code PHF

FDA records show no recalls under product code PHF.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)