510(k) · Cleared
Recalled · Class II · 2018Immulite 2000 OM-MA Model L2KOP2
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 Oct 15, 1998 as substantially equivalent to K981297 (Diagnostic Products Corp., 1998) after a 20-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it. It has been recalled once.
- Decided
- Oct 15, 1998
- Review
- 20 days
- Class
- Class II
- Product code
- LTK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981297 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK981297 Immulite OM-MA, Models Lkopz, LKOP1, LKOP5Diagnostic Products Corp. · 1998 · Recalled
- This deviceK983391 Immulite 2000 OM-MA Model L2KOP2Diagnostic Products Corp. · 1998
- Descendant · cites it directly · 0 of its ownK213510 Immulite/Immulite 1000 OM-MA, Immulite 2000 OM-MASiemens Healthcare Diagnostics Products, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK072794 Immulite 2500 OM-MA, Model L5KOPSiemens Medical Solutions Diagnostics · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981297 | Immulite OM-MA, Models Lkopz, LKOP1, LKOP5 | Diagnostic Products Corp. | 1998 | 1 |
| 0 (this device) | K983391 | Immulite 2000 OM-MA Model L2KOP2 | Diagnostic Products Corp. | 1998 | — |
| +1 | K213510 | Immulite/Immulite 1000 OM-MA, Immulite 2000 OM-MA | Siemens Healthcare Diagnostics Products, Ltd. | 2023 | — |
| +1 | K072794 | Immulite 2500 OM-MA, Model L5KOP | Siemens Medical Solutions Diagnostics | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981297 | Immulite OM-MA, Models Lkopz, LKOP1, LKOP5Summary page 1…BS 5750) Diagnostic Products Corporation 5700 West 96™ Street Los Angeles, CA 90045-5597 Euro/DPC - Not applicable DPC Registration number is 2017183 IMMULITE* OM-MA (K981297) 13 Description of Device: Intended Use of the Device: Conclusion: IMMULITE® 2000 OM-MA is a clinical use dev… | 1998 |
What descends from it? (2)
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-1683-2018 | 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?
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® 2000 OM-MA is a solid-phase, chemiluminescent enzyme immunometric assay for use with the IMMULITE® 2000 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/K983391 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983391: Immulite 2000 OM-MA Model L2KOP2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983391
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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