# K051144: Acetylcholine Receptor AB (Arab)Rra

- Pathway: 510(k) (Traditional)
- Applicant: Ibl-Hamburg GmbH
- Decided: Nov 18, 2005 after 198 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. The FDA summary names no predicate by number.

## Indications for use
The IBL Acetylcholine Receptor Antibody (ARAb) Radio Receptor Assay is for the in-vitro-diagnostic semi-quantitative determination of autoantibodies against the acetylcholine receptor in human serum and plasma. The ARAb Assay kit is useful as an aid in the differential diagnosis of Myasthenia Gravis (MG).

Source page: https://510kreport.com/device/K051144
Methodology: https://510kreport.com/methodology