# K040157: Elecsys C-Peptide Calcheck

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Feb 25, 2004 after 33 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: 3 generations back to K001015 (2000). 3 ancestors in all.
42 later devices descend from it; 6 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031698: Elecys SHBG Calcheck, Roche Diagnostics Corp. (2003) Summary page 1.

## Most influential descendants
- K100810: Elecsys  C-Peptide Calcheck 5 (2010), 32 descendants of its own
- K051185: Elecsys CA 19-9 Calcheck (2005), 12 descendants of its own
- 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

## Indications for use
The Elecsys® C-Peptide CalCheck is intended for use in the verification of the calibration established by the Elecsys® C-Peptide reagent on the Elecsys® immunoassay systems.

Source page: https://510kreport.com/device/K040157
Methodology: https://510kreport.com/methodology