510(k) · Cleared
Recalled · Class II · 2020Elecsys CA 19-9 Immunoassay, Elecsys CA 19-9 Calset
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JIT Calibrator, Secondary
Cleared on Jul 6, 2005 as substantially equivalent to K020566 (Fujirebio Diagnostics,Inc., 2002) after a 161-day review. Its family tree reaches back 1 generation to 2002. It has been recalled once.
- Decided
- Jul 6, 2005
- Review
- 161 days
- Class
- Class II
- Product code
- JIT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020566 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK020566 Fujirebio Diagnostics CA 19-9 RiaFujirebio Diagnostics,Inc. · 2002
- This deviceK050231 Elecsys CA 19-9 Immunoassay, Elecsys CA 19-9 CalsetRoche Diagnostics Corp. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020566 | Fujirebio Diagnostics CA 19-9 Ria | Fujirebio Diagnostics,Inc. | 2002 | — |
| 0 (this device) | K050231 | Elecsys CA 19-9 Immunoassay, Elecsys CA 19-9 Calset | Roche Diagnostics Corp. | 2005 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JIT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020566 | Fujirebio Diagnostics CA 19-9 RiaSummary page 2…equivalence other devices legally marketed in the United States. We claim equivalence to the Fujirebio Diagnostics CA 19-9 RIA cleared under K020566. Both products are intended for use in the quantitative determination of CA 19-9 tumor as… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 7, 2020 | Class II | Z-1444-2020 | Nonconforming Material/Component | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K020566.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (126 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050231: Elecsys CA 19-9 Immunoassay, Elecsys CA 19-9 Calset.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050231
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026