DeviceClearance

Product code OCN— Immunology

KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT

Classification name
Insulin Autoantibody Kit
Device class
Class 2
Regulation
21 CFR 866.5660
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

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.”

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

Market context for product code OCN

FDA has cleared 1 device under product code OCN, all in 2007, filed by 1 applicant company. 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.

Top applicants under product code OCN

Recent clearances under product code OCN

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