# K885297: Imx Rubella Igg, Microparticle Enzyme Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 23, 1989 after 178 days
- Product code: LFX (Enzyme Linked Immunoabsorbent Assay, Rubella)
- Device class: 2
- Regulation: 21 CFR 866.3510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K982078: Immulite Rubella Quantitative Igg, Catalog # LKRBQ1 (100 Tests), LKRBQ5 (500 Tests) (1998), 0 descendants of its own
- K963613: Immulite Rubella Igg (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K885297
Methodology: https://510kreport.com/methodology