# K101856: Elecsys Cea Calcheck 5

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Oct 5, 2010 after 96 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). 8 ancestors in all.
No later device cites it as a predicate yet.
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.
- K970452: Elecsys Calcheck Cea, Boehringer Mannheim Corp. (1997) Summary page 1.

## Indications for use
The Elecsys CIEA CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Eleesys CEA CalCheck quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K101856
Methodology: https://510kreport.com/methodology