DeviceClearance

Product code OIF— Immunology

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

Classification name
Tyrosine Phosphatase (Ia-2) Autoantibody Assay
Device class
Class 2
Regulation
21 CFR 866.5660
Advisory panel
Immunology
Total cleared
3
First cleared
Most recent

FDA classification 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).”

— U.S. Food and Drug Administration, device classification record for product code OIF under 21 CFR 866.5660, via openFDA

Market context for product code OIF

FDA has cleared 3 devices under product code OIF between 2008 and 2023, filed by 2 applicant companies. 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.

Clearances per year

Top applicants under product code OIF

Recent clearances under product code OIF

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