510(k) · Cleared
Recalled · Class II · 2018CA 125 Assay for the Advia Centaur System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Cleared on Jul 24, 2002 as substantially equivalent to K983715 (Bayer Corp., 1999) after a 132-day review. Its family tree reaches back 1 generation to 1999. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 24, 2002
- Review
- 132 days
- Class
- Class II
- Product code
- LTK
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983715 (1999). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK983715 The Immuno 1 CA 125 II Assay for the Bayer Immuno 1 System (in Vitro…Bayer Corp. · 1999
- This deviceK020828 CA 125 Assay for the Advia Centaur SystemBayer Corp. · 2002
- Descendant · cites it directly · 0 of its ownK200199 ADVIA Centaur CA 125IISiemens Healthcare Diagnostics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK142895 LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction…Fujirebio Diagnostics,Inc. · 2015
- Descendant · cites it directly · 0 of its ownK100321 Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions…Siemens Healthcare Diagnostics · 2011
Most influential descendants
Showing 3 of 3 · See all- K200199ADVIA Centaur CA 125IISiemens Healthcare Diagnostics, Inc. · 2020 · cites it directly0descendants
- K142895LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA…Fujirebio Diagnostics,Inc. · 2015 · cites it directly0descendants
- K100321Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6 Cal…Siemens Healthcare Diagnostics · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983715 | The Immuno 1 CA 125 II Assay for the Bayer Immuno 1 System (in Vitro… | Bayer Corp. | 1999 | — |
| 0 (this device) | K020828 | CA 125 Assay for the Advia Centaur System | Bayer Corp. | 2002 | — |
| +1 | K200199 | ADVIA Centaur CA 125II | Siemens Healthcare Diagnostics, Inc. | 2020 | — |
| +1 | K142895 | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges… | Fujirebio Diagnostics,Inc. | 2015 | — |
| +1 | K100321 | Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6… | Siemens Healthcare Diagnostics | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K983715 | The Immuno 1 CA 125 II Assay for the Bayer Immuno 1 System (in Vitro Diagnostic System)Summary page 1…ion of Tumor Associated Antigen Premarket Notifications”. Substantial Equivalence To: Bayer Immuno-I CA 125 II 510(k) Number: K983715 Page 2 of 2 7.2 Intended U… | 1999 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 21, 2018 | Class II | Z-1486-2018 | Other | Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use. |
| Dec 14, 2010 | Not classified | Z-1477-2011 | Process control | Positive bias (40-55%) with patient results greater than the upper limit of normal and less than the upper limit of normal |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K200199 (Siemens Healthcare Diagnostics, Inc., 2020) has gone furthest, with 0 descendants 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?
For in vitro diagnostic use in the quantitative, serial determination of CA 125 in human serum and to aid in the management of patients with ovarian carcinoma using the ADVIA CentauP System. The test is intended for use as an aid in monitoring patients previously treated for ovarian cancer. Serial testing for CA 125 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early…
Read the full statement (163 words)
For in vitro diagnostic use in the quantitative, serial determination of CA 125 in human serum and to aid in the management of patients with ovarian carcinoma using the ADVIA CentauP System. The test is intended for use as an aid in monitoring patients previously treated for ovarian cancer. Serial testing for CA 125 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of ovarian cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment. It is recomrneqded that the Bayer ADVIA Centaur CA 125 f I assay be used under the order of a physician trained and experienced in the management of gynecological cancers. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020828 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020828: CA 125 Assay for the Advia Centaur System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020828
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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