510(k) · Cleared
ClearedElecsys CA-125 II assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Professional Diagnostics · LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Cleared on Aug 6, 2015 as substantially equivalent to K972162 (Boehringer Mannheim Corp., 1998) and 1 other predicate after a 237-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Aug 6, 2015
- Review
- 237 days
- Class
- Class II
- Product code
- LTK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K001015 (2000). 8 ancestors in all, the oldest K972162 (1998). No later device cites it as a predicate yet.
- Root · 6 generations backK001015 Elecsys Thyroglobulin CalcheckRoche Diagnostics Corp. · 2000
- 5 generations backK020883 Elecsys Probnp CalcheckRoche Diagnostics Corp. · 2002
- 4 generations backK031698 Elecys SHBG CalcheckRoche Diagnostics Corp. · 2003
- 3 generations backK040157 Elecsys C-Peptide CalcheckRoche Diagnostics Corp. · 2004
- 2 generations backK100810 Elecsys C-Peptide Calcheck 5Roche Diagnostics · 2010
- 1 generation backK102086 Elecsys CA 125 II Calcheck 5Roche Diagnostics · 2010
- This deviceK143534 Elecsys CA-125 II assayRoche Professional Diagnostics · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001015 | Elecsys Thyroglobulin Calcheck | Roche Diagnostics Corp. | 2000 | — |
| −5 | K020883 | Elecsys Probnp Calcheck | Roche Diagnostics Corp. | 2002 | — |
| −4 | K031698 | Elecys SHBG Calcheck | Roche Diagnostics Corp. | 2003 | — |
| −3 | K040157 | Elecsys C-Peptide Calcheck | Roche Diagnostics Corp. | 2004 | — |
| −2 | K100810 | Elecsys C-Peptide Calcheck 5 | Roche Diagnostics | 2010 | — |
| −1 | K102086 | Elecsys CA 125 II Calcheck 5 | Roche Diagnostics | 2010 | — |
| 0 (this device) | K143534 | Elecsys CA-125 II assay | Roche Professional Diagnostics | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
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 LTK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LTK device
- #1 K240479 Access OV Monitorscore 7.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K972162 | Elecsys CA 125 IISummary page 6…d Antigen (Ca125) Product Code: LTK Predicate Device: Elecsys CA 125 II (k972162) Device Name Proprietary name: Elecsys CA 125 II CalCheck Common name: CA 125 II CalC… | 1998 |
| * | K102086 | Elecsys CA 125 II Calcheck 5Summary page 6…unassayed) Product Code: JJX Predicate Device: Elecsys CA 125 II CalCheck 5 (k102086) Establishment For the Elecsys CA 125 II assay and the CA 125 II CalCheck, the Registration establishment registra… | 2010 |
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K972162.
How does its category compare?
All LTK devicesLTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · LTK
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LTK
Too few LTK 510(k)s in any year since 2007 to give a median.
Recalls per year · LTK
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LTK
4in 2025
MAUDE reports naming product code LTK, 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 | 1 | — | 1 | 4 |
| 2008 | 0 | — | 0 | 9 |
| 2009 | 2 | — | 0 | 31 |
| 2010 | 0 | — | 3 | 12 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 33 |
| 2013 | 0 | — | 1 | 14 |
| 2014 | 0 | — | 0 | 30 |
| 2015 | 2 | — | 0 | 11 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Elecsys CA 125 II is an immunoassay for the in vitro quantitative determination of OC 125 reactive determinants in human serum, Li heparin, K2-EDTA and K3-EDTA, as well as Li-heparin plasma tubes containing separating gel on the cobas e 411 analyzer. These determinants are associated with a high molecular weight glycoprotein in serum and plasma of women with primary epithelial invasive ovarian cancer (excluding those with cancer of low malignant…
Read the full statement (145 words)
Elecsys CA 125 II is an immunoassay for the in vitro quantitative determination of OC 125 reactive determinants in human serum, Li heparin, K2-EDTA and K3-EDTA, as well as Li-heparin plasma tubes containing separating gel on the cobas e 411 analyzer.
These determinants are associated with a high molecular weight glycoprotein in serum and plasma of women with primary epithelial invasive ovarian cancer (excluding those with cancer of low malignant potential).
This immunoassay is indicated for use as an aid in the detection of residual or recurrent ovarian carcinoma. This immunoassay is further indicated for use in monitoring patients for disease progress or response to therapy.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e 411 immunoassay analyzers.
For use in the verification of the calibration established by the Elecsys CA 125 II reagent on the Elecsys and cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143534: Elecsys CA-125 II assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143534
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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