510(k) · Cleared
ClearedThe Immuno 1 CA 125 II Assay for the Bayer Immuno 1 System (in Vitro Diagnostic 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 May 14, 1999 after a 205-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- May 14, 1999
- Review
- 205 days
- Class
- Class II
- Product code
- LTK
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK983715 The Immuno 1 CA 125 II Assay for the Bayer Immuno 1 System (in Vitro…Bayer Corp. · 1999
- Descendant · cites it directly · 3 of its ownK020828 CA 125 Assay for the Advia Centaur SystemBayer Corp. · 2002 · Recalled
- Descendant · 2 generations on · 0 of its ownK200199 ADVIA Centaur CA 125IISiemens Healthcare Diagnostics, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK142895 LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction…Fujirebio Diagnostics,Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK100321 Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions…Siemens Healthcare Diagnostics · 2011
Most influential descendants
Showing 4 of 4 · See all- K020828CA 125 Assay for the Advia Centaur SystemBayer Corp. · 2002 · cites it directly3descendants
- K200199ADVIA Centaur CA 125IISiemens Healthcare Diagnostics, Inc. · 2020 · 2 generations on0descendants
- K142895LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA…Fujirebio Diagnostics,Inc. · 2015 · 2 generations on0descendants
- K100321Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6 Cal…Siemens Healthcare Diagnostics · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983715 | The Immuno 1 CA 125 II Assay for the Bayer Immuno 1 System (in Vitro… | Bayer Corp. | 1999 | — |
| +1 | K020828 | CA 125 Assay for the Advia Centaur System | Bayer Corp. | 2002 | 2 |
| +2 | K200199 | ADVIA Centaur CA 125II | Siemens Healthcare Diagnostics, Inc. | 2020 | — |
| +2 | K142895 | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges… | Fujirebio Diagnostics,Inc. | 2015 | — |
| +2 | 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 |
|---|---|---|
| 2002 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020828 | CA 125 Assay for the Advia Centaur System | 2002 | 3 |
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, K020828 (Bayer Corp., 2002) has gone furthest, with 3 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?
The Bayer Immuno 1™ CA 125II Assay is an in vitro device for the quantitative measurement of OC 125 determinants associated with a high molecular weight glycoprotein in serum of women with epithelial invasive ovarian cancer. The Bayer Immuno 1™ CA 125II Assay is indicated as a one time test 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…
Read the full statement (177 words)
The Bayer Immuno 1™ CA 125II Assay is an in vitro device for the quantitative measurement of OC 125 determinants associated with a high molecular weight glycoprotein in serum of women with epithelial invasive ovarian cancer. The Bayer Immuno 1™ CA 125II Assay is indicated as a one time test 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 second-look procedures. An assay value greater than 35 U/mL is predictive of residual disease provided alternative causes of an elevated CA 125II value can be excluded.
The Bayer Immuno 1™ CA 125II Assay is further indicated as an aid in the management (monitoring) of ovarian cancer patients when used in conjunction with other diagnostic procedures.
It is recommended that the Bayer Immuno 1™ CA 125II Assay be used under the order of a physician trained and experienced in 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983715 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983715: The Immuno 1 CA 125 II Assay for the Bayer Immuno 1 System (in Vitro Diagnostic System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983715
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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