OIF — Tyrosine Phosphatase (Ia-2) Autoantibody Assay Class II

FDA Device Classification

Classification Details

Product Code: OIF
Device Class: Class II
Regulation Number: 866.5660
Submission Type
Review Panel: IM
Medical Specialty: Immunology
Implant: No

Definition

The device is used for the semi-quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K220085	kronus	KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit	August 24, 2023
K171731	kronus	KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit	January 19, 2018
K073590	kronus market development associates	KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT	April 10, 2008