510(k) · Cleared
ClearedElecsys CA 125 II
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 18, 1998 after a 282-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Mar 18, 1998
- Review
- 282 days
- Class
- Class II
- Product code
- LTK
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK972162 Elecsys CA 125 IIBoehringer Mannheim Corp. · 1998
- Descendant · cites it directly · 1 of its ownK983875 Vitros Immunodiagnostic Products CA 125 II Calibrators, Vitros…Ortho-Clinical Diagnostics, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 0 of its ownK221355 VITROS Immuodiagnostic Products CA 125 II Reagent PackOrtho Clinical Diagnostics · 2022
- Descendant · cites it directly · 0 of its ownK143534 Elecsys CA-125 II assayRoche Professional Diagnostics · 2015
- Descendant · cites it directly · 0 of its ownK980240 Elecsys CA 125II on the Elecsys 1010Boehringer Mannheim Corp. · 1998
Most influential descendants
Showing 4 of 4 · See all- K983875Vitros Immunodiagnostic Products CA 125 II Calibrators, Vitros Immunodiagnostic Products…Ortho-Clinical Diagnostics, Inc. · 1999 · cites it directly1descendant
- K221355VITROS Immuodiagnostic Products CA 125 II Reagent PackOrtho Clinical Diagnostics · 2022 · 2 generations on0descendants
- K143534Elecsys CA-125 II assayRoche Professional Diagnostics · 2015 · cites it directly0descendants
- K980240Elecsys CA 125II on the Elecsys 1010Boehringer Mannheim Corp. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972162 | Elecsys CA 125 II | Boehringer Mannheim Corp. | 1998 | — |
| +1 | K983875 | Vitros Immunodiagnostic Products CA 125 II Calibrators, Vitros… | Ortho-Clinical Diagnostics, Inc. | 1999 | 1 |
| +2 | K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent Pack | Ortho Clinical Diagnostics | 2022 | — |
| +1 | K143534 | Elecsys CA-125 II assay | Roche Professional Diagnostics | 2015 | — |
| +1 | K980240 | Elecsys CA 125II on the Elecsys 1010 | Boehringer Mannheim Corp. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | — | Centocor® CA 125 II™ Ria Named without a submission number |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K983875 (Ortho-Clinical Diagnostics, Inc., 1999) has gone furthest, with 1 descendant of its own.
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 125 II 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 125 II is further indicated for serial measurement of CA 125 II 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/K972162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972162: Elecsys CA 125 II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972162
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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