510(k) · Cleared
ClearedImmulite/Immulite 1000 OM-MA, Immulite 2000 OM-MA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics Products, Ltd. · LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Cleared on Sep 8, 2023 as substantially equivalent to K981297 (Diagnostic Products Corp., 1998) and 1 other predicate after a 675-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Sep 8, 2023
- Review
- 675 days
- Class
- Class II
- Product code
- LTK
- Recalls
- None
- Predicates
- 2
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 deviceK213510 Immulite/Immulite 1000 OM-MA, Immulite 2000 OM-MASiemens Healthcare Diagnostics Products, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981297 | Immulite OM-MA, Models Lkopz, LKOP1, LKOP5 | Diagnostic Products Corp. | 1998 | 1 |
| −1 | K983391 | Immulite 2000 OM-MA Model L2KOP2 | Diagnostic Products Corp. | 1998 | 1 |
| 0 (this device) | K213510 | Immulite/Immulite 1000 OM-MA, Immulite 2000 OM-MA | Siemens Healthcare Diagnostics Products, Ltd. | 2023 | — |
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? (2)
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 |
|---|---|---|---|
| * | K981297 | Immulite OM-MA, Models Lkopz, LKOP1, LKOP5Summary page 4…OM-MA and IMMULITE 2000 OM-MA, manufactured by Siemens Healthcare Diagnostics Products Ltd, Glyn Rhonwy, Llanberis, Wales, United Kingdom, were cleared by the FDA under K981297 and K983391. 5.4 Device Description The IMMULITE®/IMMULITE 1000 OM-MA Assay is comprised of the following compon… | 1998 |
| * | K983391 | Immulite 2000 OM-MA Model L2KOP2Summary page 4…MMULITE 2000 OM-MA, manufactured by Siemens Healthcare Diagnostics Products Ltd, Glyn Rhonwy, Llanberis, Wales, United Kingdom, were cleared by the FDA under K981297 and K983391. 5.4 Device Description The IMMULITE®/IMMULITE 1000 OM-MA Assay is comprised of the following components: Comp… | 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 25 years and passes through 2 companies; a new generation was cleared every 24.9 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 1 other device also cites its predicate K981297.
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. 2023, 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?
For in vitro diagnostic use with the IMMULITE® and IMMULITE® 1000 Analyzers — for the quantitative measurement of CA125 antigen in serum, as an aid in monitoring the response to therapy for patients with epithelian 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. For in vitro diagnostic use with the IMMULITE® 2000 Systems Analyzers —…
Read the full statement (116 words)
For in vitro diagnostic use with the IMMULITE® and IMMULITE® 1000 Analyzers — for the quantitative measurement of CA125 antigen in serum, as an aid in monitoring the response to therapy for patients with epithelian 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.
For in vitro diagnostic use with the IMMULITE® 2000 Systems Analyzers — for the quantitative measurement of CA125 antigen in serum, as an aid in monitoring the response to therapy for patients with epithelian 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213510 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213510: Immulite/Immulite 1000 OM-MA, Immulite 2000 OM-MA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213510
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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