# K931059: Imx Rubella Igm Antibody Assay

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Dec 19, 1994 after 658 days
- Product code: LFX (Enzyme Linked Immunoabsorbent Assay, Rubella)
- Device class: 2
- Regulation: 21 CFR 866.3510
- Recalls of this device: 1 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jul 22, 2003 · Not classified · Z-1129-03: The package insert contains incomplete information for the English text. Pages 4 and 5 are missing and pages 14 and 15 are duplicated.

Source page: https://510kreport.com/device/K931059
Methodology: https://510kreport.com/methodology