# K051185: Elecsys CA 19-9 Calcheck

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jul 6, 2005 after 58 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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.
12 later devices descend from it; 1 cites it directly.
0 of 17 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
- 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

## Indications for use
The Elecsys® CA 19-9 CalCheck™ is intended for use in the verification of the calibration established by the Elecsys® CA 19-9 reagent on the Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.

Source page: https://510kreport.com/device/K051185
Methodology: https://510kreport.com/methodology