OIF

Tyrosine Phosphatase (Ia-2) Autoantibody Assay

Product code: OIF
Device name: Tyrosine Phosphatase (Ia-2) Autoantibody Assay
Device class: Class 2
21 CFR: 21 CFR 866.5660
Medical specialty: Immunology
Marketing pathway: 510(K)
Flag: Third-party review eligible
510(k) clearances (all years, FDA): 3 (all years; only the last 3 years are listed here)

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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OIF

Classification and pathway per current FDA publications. Data from openFDA (CC0).