# K050231: Elecsys CA 19-9 Immunoassay, Elecsys CA 19-9 Calset

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jul 6, 2005 after 161 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K020566 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020566: Fujirebio Diagnostics CA 19-9 Ria, Fujirebio Diagnostics,Inc. (2002) Summary page 2.

## Recalls of this device
- Feb 7, 2020 · Class II · Z-1444-2020: The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9 reagent, which may affect clinical interpretation.

## Indications for use
Immunoassay for the in vitro quantitative determination of CA 19-9 tumor associated antigen, in human serum and plasma. The assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in the monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of CA 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS El 70 (Elecsys module) immunoassay analyzers. Elecsys CA 19-9 is used for calibrating the quantitative Elecsys CA 19-9 assay on the Elecsys immunoassay systems.

Source page: https://510kreport.com/device/K050231
Methodology: https://510kreport.com/methodology