# K072617: Elecsys Rubella Igg Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Dec 5, 2008 after 445 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 K983805 (1999). 2 ancestors in all.
2 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)
- K983805: The Aptus (Automated) Application of the Rubella Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) FO, Zeus Scientific, Inc. (1999) Summary page 2.
- K984180: The Aptus (Automated) Application of the Rubella Igm Elisa Test System, Zeus Scientific, Inc. (1999) Summary page 3.

## Most influential descendants
- K131605: Elecsys Precicontrol CMV Igg, Elecsys CMV Igg Immunoassay (2014), 1 descendant of its own
- K220911: Elecsys CMV IgG (2022), 0 descendants of its own

## Indications for use
The Elecsys Rubella IgG immunoassay is for the in vitro quantitative determination of IgG 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 assessment of immune status to rubella in individuals including women of childbearing age. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers. Elecsys PreciControl Rubella IgG is used for quality control of the Elecsys Rubella IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K072617
Methodology: https://510kreport.com/methodology