OCN

Insulin Autoantibody Kit

Product code

OCN

Device name

Insulin Autoantibody Kit

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)

1 (all years; only the last 3 years are listed here)

FDA classification definition

The device is used for the semi-quantitative determination of insulin autoantibodies in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.

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