# K092322: Elecsys Rubella Igm Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Mar 12, 2010 after 220 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: 5 generations back to K931172 (1993). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984180: The Aptus (Automated) Application of the Rubella Igm Elisa Test System, Zeus Scientific, Inc. (1999) Summary page 3.
- K031990: Elecsys Precicontrol Troponin T, Roche Diagnostics Corp. (2003) Summary page 2.

## Most influential descendants
- K142133: Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV Igm (2014), 1 descendant of its own
- K163569: Elecsys CMV IgM (2017), 0 descendants of its own

## Indications for use
The Elecsys Rubella IgM immunoassay is for the in vitro qualitative determination of IgM antibodies to rubella virus in human serum and Li-heparin, K3-EDTA, and sodium citrate plasma. This assay may be used as an aid in the presumptive diagnosis of an acute or recent rubella infection in individuals, including women of childbearing age. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers. NOTE: This assay has not been cleared/approved by the FDA for blood/plasma donor screening. Elecsys PreciControl Rubella IgM is used for quality control of the Elecsys Rubella IgM immunoassay on the Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K092322
Methodology: https://510kreport.com/methodology