# K220085: KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

- Pathway: 510(k) (Traditional)
- Applicant: Kronus, Inc.
- Decided: Aug 24, 2023 after 590 days
- Product code: OIF (Tyrosine Phosphatase (Ia-2) Autoantibody Assay)
- 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 IA-2 Autoantibody (IA-2Ab) ELISA Kit is for the quantitative or qualitative determination of antibodies to Islet Antigen-2 (IA-2) in human serum. The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.

Source page: https://510kreport.com/device/K220085
Methodology: https://510kreport.com/methodology