# K102269: Elecsys Ige Calcheck 5

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Oct 7, 2010 after 59 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K133122: Immulite 2000; 3GALLERGY Specific Ige Control Verification Material (CVM), Total Ige Control Verification Material (CVM) (2013), 1 descendant of its own
- K143680: ADVIA Centaur IgE Master Curve Material (2015), 0 descendants of its own

Source page: https://510kreport.com/device/K102269
Methodology: https://510kreport.com/methodology