# K101365: Elecsys CA 19-9 Calcheck 5

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Oct 5, 2010 after 141 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.
11 later devices descend from it; 1 cites it directly.
0 of 18 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.
- K051185: Elecsys CA 19-9 Calcheck, Roche Diagnostics Corp. (2005) Summary page 1.

## Most influential descendants
- K122242: Elecsys CA 15-3 II Calcheck 5 (2012), 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
- K191595: ARCHITECT STAT High Sensitivity Troponin-I (2019), 2 descendants of its own
- K202525: Alinity i STAT High Sensitivity Troponin-I (2022), 1 descendant of its own
- K230994: Alinity i STAT High Sensitivity Troponin-I (2023), 0 descendants of its own

## Indications for use
The Elecsys CA 19-9 CaiCheck 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 19-9 reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K101365
Methodology: https://510kreport.com/methodology