# K102086: Elecsys CA 125 II Calcheck 5

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Nov 1, 2010 after 98 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). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100810: Elecsys  C-Peptide Calcheck 5, Roche Diagnostics (2010) Summary page 1.
- K003967: CA 125 II Calcheck, Roche Diagnostics Corp. (2001) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The Elecsys CA 125 II 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 CA 125 II reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.

Source page: https://510kreport.com/device/K102086
Methodology: https://510kreport.com/methodology