510(k) · Cleared
ClearedElecsys CA 125II on the Elecsys 1010
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Cleared on Mar 25, 1998 as substantially equivalent to K972162 (Boehringer Mannheim Corp., 1998) after a 61-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Mar 25, 1998
- Review
- 61 days
- Class
- Class II
- Product code
- LTK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972162 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK972162 Elecsys CA 125 IIBoehringer Mannheim Corp. · 1998
- This deviceK980240 Elecsys CA 125II on the Elecsys 1010Boehringer Mannheim Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972162 | Elecsys CA 125 II | Boehringer Mannheim Corp. | 1998 | — |
| 0 (this device) | K980240 | Elecsys CA 125II on the Elecsys 1010 | Boehringer Mannheim Corp. | 1998 | — |
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? (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 |
|---|---|---|---|
| * | K972162 | Elecsys CA 125 II Cleared while this submission was under review Summary page 3…Comparison to predicate device CA125 1010 510(k).doc The Boehringer Mannheim Elecsys® CA 12511 Assay is under review for use on the Elecsys 2010 immunoassay analyzer (K972162). The application of the Elecsys® CA 12511 Assay on the Elecsys 1010 immunoassay analyzer is substantially equivalent to the same… | 1998 |
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.
- 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.
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?
Immunoassay for the in vitro determination of OC 125 reactive determinants. 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. The Elecsys® CA 12511 is indicated for use as an aid in the detection of residual or recurrent ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures. The Elecsys CA 12511 is further indicated for serial measurement of CA 12511 to aid in the management of cancer patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980240: Elecsys CA 125II on the Elecsys 1010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980240
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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