# K243168: Alinity i Rubella IgG

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 20, 2025 after 263 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
Longest line of descent: 2 generations back to K954045 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080766: Vidas Rub Igg, bioMerieux, Inc. (2008) Summary page 6.

## Indications for use
The Alinity i Rubella IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of IgG antibodies to rubella virus in human serum, serum separator, and plasma tubes (lithium heparin, lithium heparin separator, and tripotassium EDTA) on the Alinity i system. The Alinity i Rubella IgG assay is to be used as an aid in the determination of immune status to rubella in individuals including women of child-bearing age. The Alinity i Rubella IgG assay has not been cleared for use in screening blood, plasma, or tissue donors. The performance of this device has not been established for cord blood or neonatal samples. Likewise, performance has not been established for populations of immunocompromised or immunosuppressed individuals.

Source page: https://510kreport.com/device/K243168
Methodology: https://510kreport.com/methodology