# K010668: Bayer Diagnostics Advia Centaur Rubella Igm Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jul 5, 2001 after 121 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K122397: Liaison Rubella Igm, Liaison Control Rubella Igm (2012), 3 descendants of its own
- K132234: Liaison (R) Toxo Igg II, Liaison (R) Control Toxo Igg II (2013), 2 descendants of its own
- K161139: LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (2016), 1 descendant of its own
- K092587: Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection System (2010), 1 descendant of its own
- K181464: LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (2018), 0 descendants of its own

Source page: https://510kreport.com/device/K010668
Methodology: https://510kreport.com/methodology