# K042248: Kronus, Inc.'S Acetylcholine Receptor Antibody (Achrab) Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Kronus Market Development Associates, Inc.
- Decided: Dec 17, 2004 after 120 days
- Product code: NST (Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking)
- 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 Acetylcholine Receptor Antibody (AChRAb) Assay Kit is for the quantitative or qualitative determination of acetylcholine receptor antibody in human serum. The KRONUS Acetylcholine Receptor Antibody(AChRAb) kit is useful as an aid in the differential diagnosis of Myasthenia Gravis.

Source page: https://510kreport.com/device/K042248
Methodology: https://510kreport.com/methodology