# K091468: Ivd Technologies Achrab Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Ivd Technologies
- Decided: Nov 20, 2009 after 186 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 AChRAb Assay is a radioimmunoassay for the in-vitro-diagnostic semi-quantitative determination of autoantibodies against the acetylcholine receptor in human serum. The AChRAb assay is useful as an aid in the differential diagnosis of Myasthenia Gravis (MG) in conjunction with other clinical and laboratory findings.

Source page: https://510kreport.com/device/K091468
Methodology: https://510kreport.com/methodology