# K003969: Elecsys CA 125 II Calset

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Jan 12, 2001 after 21 days
- Product code: JIS (Calibrator, Primary)
- 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K140112: CA 125 II Calset II (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K003969
Methodology: https://510kreport.com/methodology