# K003967: CA 125 II Calcheck

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Jan 12, 2001 after 21 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K102086: Elecsys CA 125 II Calcheck 5 (2010), 2 descendants of its own
- K143534: Elecsys CA-125 II assay (2015), 0 descendants of its own
- K132739: Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification Material (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K003967
Methodology: https://510kreport.com/methodology