# K051061: Kronus Glutamic Acid Decarboxylase Antibody Kit

- Pathway: 510(k) (Traditional)
- Applicant: Kronus Market Development Associates, Inc.
- Decided: Nov 4, 2005 after 192 days
- Product code: NWG (Autoantibodies, Glutamic Acid Decarboxylase (Gad))
- 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 GADAb RiA Assay Kit is for the semi-quantitative determination of glutamic acid decarboxylase antibody in human serum. The KRONUS GADAb RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).

Source page: https://510kreport.com/device/K051061
Methodology: https://510kreport.com/methodology