# K092585: Elecsys Rubella Igga Calcheck 5

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Oct 30, 2009 after 67 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: 5 generations back to K001015 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090311: Elecsys Rubella Igg Calcheck, Roche Diagnostics (2009) Summary page 1.

## Indications for use
The Elecsys Rubella IgG CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Rubella IgG reagent on the Elecsys 2010, MODULAR ANALYTICS El70 and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K092585
Methodology: https://510kreport.com/methodology