510(k) · Cleared
ClearedCA 125 II Calset II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · JIT Calibrator, Secondary
Cleared on Jun 6, 2014 as substantially equivalent to K003969 (Roche Diagnostics Corp., 2001) after a 142-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jun 6, 2014
- Review
- 142 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003969 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003969 Elecsys CA 125 II CalsetRoche Diagnostics Corp. · 2001
- This deviceK140112 CA 125 II Calset IIRoche Diagnostics · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003969 | Elecsys CA 125 II Calset | Roche Diagnostics Corp. | 2001 | — |
| 0 (this device) | K140112 | CA 125 II Calset II | Roche Diagnostics | 2014 | — |
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 |
|---|---|---|---|
| * | K003969 | Elecsys CA 125 II CalsetSummary page 1…other products in Predicate commercial distribution intended for similar use. We claim equivalency to Device the currently marketed CA 125 CalSet (k003969). The CA 125 11 CalSet [1lisa lyophilized product consisting of human CA 125 Device in an equi… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
CA 125 11CalSet 11is used for calibrating the quantitative Elecsys CA 125 11assay on the Elecsys and cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140112: CA 125 II Calset II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140112
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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