510(k) · Cleared
Recalled · Class II · 2018Immulite OM-MA, Models Lkopz, LKOP1, LKOP5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Cleared on Sep 18, 1998 after a 163-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 3 later devices descend from it. It has been recalled once.
- Decided
- Sep 18, 1998
- Review
- 163 days
- Class
- Class II
- Product code
- LTK
- Recalls
- 1
- Predicates
- 1
3 later devices descend from it, 2 citing it directly.
- This deviceK981297 Immulite OM-MA, Models Lkopz, LKOP1, LKOP5Diagnostic Products Corp. · 1998
- Descendant · cites it directly · 2 of its ownK983391 Immulite 2000 OM-MA Model L2KOP2Diagnostic Products Corp. · 1998 · Recalled
- Descendant · cites it directly · 0 of its ownK213510 Immulite/Immulite 1000 OM-MA, Immulite 2000 OM-MASiemens Healthcare Diagnostics Products, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK072794 Immulite 2500 OM-MA, Model L5KOPSiemens Medical Solutions Diagnostics · 2007
Most influential descendants
Showing 3 of 3 · See all- K983391Immulite 2000 OM-MA Model L2KOP2Diagnostic Products Corp. · 1998 · cites it directly2descendants
- K213510Immulite/Immulite 1000 OM-MA, Immulite 2000 OM-MASiemens Healthcare Diagnostics Products, Ltd. · 2023 · cites it directly0descendants
- K072794Immulite 2500 OM-MA, Model L5KOPSiemens Medical Solutions Diagnostics · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981297 | Immulite OM-MA, Models Lkopz, LKOP1, LKOP5 | Diagnostic Products Corp. | 1998 | — |
| +1 | K983391 | Immulite 2000 OM-MA Model L2KOP2 | Diagnostic Products Corp. | 1998 | 1 |
| +1 | K213510 | Immulite/Immulite 1000 OM-MA, Immulite 2000 OM-MA | Siemens Healthcare Diagnostics Products, Ltd. | 2023 | — |
| +2 | K072794 | Immulite 2500 OM-MA, Model L5KOP | Siemens Medical Solutions Diagnostics | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2007 | 1 | 0 |
| 2023 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | P85009 | Centocor CA 125 II RIA Number could not be read Summary page 1…nostic Products Corporation (DPC) 5700 West 96™ Street Los Angeles, CA 90045-5597 Euro/DPC — Not applicable DPC Registration number 1s 2017183 Centocor® CA 125 U™ RIA (P85009/S001- S007) 09/16/98 WED 08:07 FAX 1 310 645 9999 DPC LA ADMIN. ooz Description of Device: IMMULITE® OM-MA is a… |
What descends from it? (3)
2 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 |
|---|---|---|---|---|
| Jan 2, 2018 | Class II | Z-1682-2018 | Error in labeling | Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K983391 (Diagnostic Products Corp., 1998) has gone furthest, with 2 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?
IMMULITE OM-MA is a chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of CA 125 antigen in serum. It is intended strictly for in vitro diagnostic use 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.
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/K981297 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981297: Immulite OM-MA, Models Lkopz, LKOP1, LKOP5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981297
Report an extraction error
Are you the manufacturer?
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