# K070183: Kronus Insulin Autoantibody (Iaa) Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Kronus Market Development Associates, Inc.
- Decided: Jul 13, 2007 after 175 days
- Product code: OCN (Insulin Autoantibody Kit)
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The KRONUS Insulin Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to insulin in human serum. The KRONUS Insulin Autoantibody RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.

Source page: https://510kreport.com/device/K070183
Methodology: https://510kreport.com/methodology