510(k) · Cleared
Recalled · Class II · 2017BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model 387620, 387647
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · MOI System, Test, Immunological, Antigen, Tumor
Cleared on Feb 3, 2004 as substantially equivalent to K963926 (Abbott Laboratories, 1997) after a 127-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it. It has been recalled once.
- Decided
- Feb 3, 2004
- Review
- 127 days
- Class
- Class II
- Product code
- MOI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963926 (1997). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK963926 Axsym CA 15-3Abbott Laboratories · 1997 · Recalled
- This deviceK033036 BR Monitor and BR Monitor Calibrators on the Access Immunoassay…Beckman Coulter, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK072612 Access Immunoassay Systems BR Monitor, and Calibrators, Model (S)…Beckman Coulter, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 1 of its ownK100344 Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista…Siemens Healthcare Diagnostics · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK240403 Access BR MonitorBeckman Coulter, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK122398 Rapidpoint 500 System Measurement Cartridge with CalibratorsSiemens Healthcare Diagnostics, Inc. · 2012 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K072612Access Immunoassay Systems BR Monitor, and Calibrators, Model (S) 387620,and 387647Beckman Coulter, Inc. · 2007 · cites it directly3descendants
- K100344Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator…Siemens Healthcare Diagnostics · 2011 · 2 generations on1descendant
- K240403Access BR MonitorBeckman Coulter, Inc. · 2024 · cites it directly0descendants
- K122398Rapidpoint 500 System Measurement Cartridge with CalibratorsSiemens Healthcare Diagnostics, Inc. · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963926 | Axsym CA 15-3 | Abbott Laboratories | 1997 | 4 |
| 0 (this device) | K033036 | BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model… | Beckman Coulter, Inc. | 2004 | — |
| +1 | K072612 | Access Immunoassay Systems BR Monitor, and Calibrators, Model (S) 387620,and… | Beckman Coulter, Inc. | 2007 | 1 |
| +2 | K100344 | Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7… | Siemens Healthcare Diagnostics | 2011 | 1 |
| +1 | K240403 | Access BR Monitor | Beckman Coulter, Inc. | 2024 | — |
| +3 | K122398 | Rapidpoint 500 System Measurement Cartridge with Calibrators | Siemens Healthcare Diagnostics, Inc. | 2012 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2024 | 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 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 |
|---|---|---|---|
| * | K963926 | Axsym CA 15-3Summary page 1…Test, Immunological, Antigen, Tumor Predicate Device Abbott AxSYM® CA 15-3 TM Abbott Laboratories, Diagnostics Division Abbott Park, IL 60064 510(k) Number: k963926 Device Description The Access BR Monitor reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, S… | 1997 |
What descends from it? (4)
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 |
|---|---|---|---|---|
| Apr 13, 2017 | Class II | Z-2074-2017 | Other | Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de s¿curit¿ du Medicament et des produits de… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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.
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?
The Access BR Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 15-3 antigen to aid in the management of breast cancer patients. Serial testing for patient CA 15-3 antigen concentrations should be used in conjunction with other clinical methods for monitoring breast cancer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033036 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033036: BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model 387620, 387647.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033036
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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