510(k) · Cleared
ClearedImmulite 2500 OM-MA, Model L5KOP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions Diagnostics · LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Cleared on Nov 5, 2007 as substantially equivalent to K983391 (Diagnostic Products Corp., 1998) after a 35-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Nov 5, 2007
- Review
- 35 days
- Class
- Class II
- Product code
- LTK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K981297 (1998). No later device cites it as a predicate yet.
- Root · 2 generations backK981297 Immulite OM-MA, Models Lkopz, LKOP1, LKOP5Diagnostic Products Corp. · 1998 · Recalled
- 1 generation backK983391 Immulite 2000 OM-MA Model L2KOP2Diagnostic Products Corp. · 1998 · Recalled
- This deviceK072794 Immulite 2500 OM-MA, Model L5KOPSiemens Medical Solutions Diagnostics · 2007
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K983391 | Immulite 2000 OM-MA Model L2KOP2Summary page 2…Gwynedd, LL55 4EL United Kingdom Substantially Equivalent Predicate Device: IMMULITE 2000 OM-MA Immunoassay (K983391) Description of Device: The IMMULITE 2500 OM-MA Immunoassay is a solid-phase, two-site,… | 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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 9.1 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 1 other device also cites its predicate K983391.
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. 2007, this device’s year, is highlighted.
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?
Immulite 2500 OM-MA
For in vitro diagnostic use with the IMMULITE 2500 Analyzer- for the quantitative measurement of CA125 antigen in human serum, as an aid in monitoring the response to therapy for patients with epithelial ovarian cancer and in detecting residual ovarian cancer in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures
Immulite Tumor Marker Controls
TMC is an assayed, serum-based, tri-level control containing analytes associated with malignancy which are commonly measured by immunoassay. It is intended strictly for in vitro use as an aid in monitoring the day-to-day performance of assays for these constituents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072794: Immulite 2500 OM-MA, Model L5KOP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072794
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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