# K090311: Elecsys Rubella Igg Calcheck

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: May 5, 2009 after 88 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K001015 (2000). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040157: Elecsys C-Peptide Calcheck, Roche Diagnostics Corp. (2004) Summary page 1.

## Most influential descendants
- K092585: Elecsys Rubella Igga Calcheck 5 (2009), 0 descendants of its own

## Indications for use
The Elecsys Rubella IgG CalCheck is an assayed calibrator control intended for use in the verification of the calibration established by the Elecsys Rubella IgG reagent on the Elecsys 2010, MODULAR ANALYTICS E170 and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K090311
Methodology: https://510kreport.com/methodology