# K100810: Elecsys  C-Peptide Calcheck 5

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Apr 26, 2010 after 35 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: 4 generations back to K001015 (2000). 4 ancestors in all.
32 later devices descend from it; 6 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040157: Elecsys C-Peptide Calcheck, Roche Diagnostics Corp. (2004) Summary page 1.

## Most influential descendants
- K101365: Elecsys CA 19-9 Calcheck 5 (2010), 11 descendants of its own
- K122242: Elecsys CA 15-3 II Calcheck 5 (2012), 10 descendants of its own
- K103221: Elecys HGH Calset, Elecsys HGH Calcheck 5 (2010), 10 descendants of its own
- K162895: Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 (2017), 8 descendants of its own
- K113546: Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys Vitamin D Calcheck 5 (2012), 8 descendants of its own

## Indications for use
The Elecsys C-Peptide CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the serum and plasma assay range established by the Elecsys C-Peptide reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K100810
Methodology: https://510kreport.com/methodology