510(k) · Cleared
ClearedCpa 125 II Assay for the Technicon Immuno 1 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 Oct 31, 1997 after a 385-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 31, 1997
- Review
- 385 days
- Class
- Class II
- Product code
- LTK
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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?
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.
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 125 Il Assay is an in vitro device for the quantitative measurement of OC 125 reactive determinants associated with a high molecular glycoprotein in serum of women with primary epithelial invasive ovarian cancer. The CA 125 Il Assay is indicated as a one-time test for use as an aid in the detection of residual ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look…
Read the full statement (151 words)
The Bayer Immuno 1™ CA 125 Il Assay is an in vitro device for the quantitative measurement of OC 125 reactive determinants associated with a high molecular glycoprotein in serum of women with primary epithelial invasive ovarian cancer.
The CA 125 Il Assay is indicated as a one-time test for use as an aid in the detection of residual ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures.” An assay value of greater than 35 U/mL is indicative of residual disease, provided that alternative causes of elevated CA 125 II Assay values can be excluded (refer to “Limitations of the Procedure” section). It is recommended that the assessment and treatment of patients with ovarian cancer and the use of the Bayer Immuno 1 CA 125 II Assay be under the order of a physician trained and experienced in the management of gynecological cancers.
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/K964098 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964098: Cpa 125 II Assay for the Technicon Immuno 1 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964098
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026