510(k) · Cleared
ClearedImmulite® 2000 BR-MA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics Products, Ltd. · MOI System, Test, Immunological, Antigen, Tumor
Cleared on Mar 13, 2024 as substantially equivalent to K013984 (Diagnostic Products Corp., 2002) after a 90-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Mar 13, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- MOI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K964703 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK964703 The CA 15-3 Assay for the Technicon Immuno 1 System (in Vitro…Bayer Corp. · 1997
- 1 generation backK013984 Immulite BR-MA, Model #LKBR; Immulite 2000 BR-MA, Model #L2KBRDiagnostic Products Corp. · 2002 · Recalled
- This deviceK233946 Immulite® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964703 | The CA 15-3 Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System) | Bayer Corp. | 1997 | — |
| −1 | K013984 | Immulite BR-MA, Model #LKBR; Immulite 2000 BR-MA, Model #L2KBR | Diagnostic Products Corp. | 2002 | 2 |
| 0 (this device) | K233946 | Immulite® 2000 BR-MA | Siemens Healthcare Diagnostics Products, Ltd. | 2024 | — |
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 MOI? 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 MOI device
- #1 K240403 Access BR Monitorscore 7.9 · 3 generations · 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 |
|---|---|---|---|
| * | K013984 | Immulite BR-MA, Model #LKBR; Immulite 2000 BR-MA, Model #L2KBRSummary page 4…ate device IMMULITE® 2000 BR-MA, manufactured by Siemens Healthcare Diagnostics Products Ltd, Glyn Rhonwy, Llanberis, Wales, United Kingdom, was cleared by the FDA under K013984. IV. Device Description The IMMULITE® 2000 BR-MA assay was cleared under K013984. The components of the cleared assay were modi… | 2002 |
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 27 years and passes through 3 companies; a new generation was cleared every 22.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All MOI devicesMOI System, Test, Immunological, Antigen, Tumor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MOI
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MOI
Too few MOI 510(k)s in any year since 2007 to give a median.
Recalls per year · MOI
2in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOI
6in 2025
MAUDE reports naming product code MOI, 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 | 2 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 22 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 2 | 4 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 52 |
| 2015 | 0 | — | 0 | 28 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 2 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 16 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 2 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers - for the quantitative measurement of CA15-3 antigen in human serum and plasma, as an aid in the detection of recurrence in previously treated stage II and stage III breast cancer patients, and in the management of metastatic breast cancer patients by monitoring disease progression or response to treatment. Serial testing for patient CA15-3 values should be used in conjunction with other clinical methods used for detecting early recurrence in stage II and stage III disease and for monitoring response to treatment in patients with metastatic breast cancer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233946 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233946: Immulite® 2000 BR-MA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233946
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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