# K140112: CA 125 II Calset II

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jun 6, 2014 after 142 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K003969 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003969: Elecsys CA 125 II Calset, Roche Diagnostics Corp. (2001) Summary page 1.

## Indications for use
CA 125 11CalSet 11is used for calibrating the quantitative Elecsys CA 125 11assay on the Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K140112
Methodology: https://510kreport.com/methodology