# K122397: Liaison Rubella Igm, Liaison Control Rubella Igm

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Sep 6, 2012 after 30 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: 1 generation back to K010668 (2001). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010668: Bayer Diagnostics Advia Centaur Rubella Igm Assay, Bayer Corp. (2001) Summary page 2.

## Most influential descendants
- 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
- K181464: LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (2018), 0 descendants of its own

## Indications for use
The LIAISON® Rubella IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgM antibodies to rubella virus in human serum samples. It is intended for use as an aid in the diagnosis of a current or recent Rubella infection in individuals with signs and symptoms of Rubella, or suspected of having rubella virus infection, including women of child bearing age. The LIAISON® Control Rubella IgM (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Rubella IgM assay. The performance characteristics of LIAISON® Rubella IgM controls have not been established for any other assays or instrument platforms.

Source page: https://510kreport.com/device/K122397
Methodology: https://510kreport.com/methodology