510(k) · Cleared
ClearedAccess BR Monitor
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 May 9, 2024 as substantially equivalent to K072612 (Beckman Coulter, Inc., 2007) and 1 other predicate after a 90-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- May 9, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- MOI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K963926 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK963926 Axsym CA 15-3Abbott Laboratories · 1997 · Recalled
- 2 generations backK033036 BR Monitor and BR Monitor Calibrators on the Access Immunoassay…Beckman Coulter, Inc. · 2004 · Recalled
- 1 generation backK072612 Access Immunoassay Systems BR Monitor, and Calibrators, Model (S)…Beckman Coulter, Inc. · 2007 · Recalled
- This deviceK240403 Access BR MonitorBeckman Coulter, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963926 | Axsym CA 15-3 | Abbott Laboratories | 1997 | 4 |
| −2 | K033036 | BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model… | Beckman Coulter, Inc. | 2004 | 1 |
| −1 | K072612 | Access Immunoassay Systems BR Monitor, and Calibrators, Model (S) 387620,and… | Beckman Coulter, Inc. | 2007 | 1 |
| 0 (this device) | K240403 | Access BR Monitor | Beckman Coulter, Inc. | 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 K233946 Immulite® 2000 BR-MAscore 7.3 · 2 generations · 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 |
|---|---|---|---|
| * | K072612 | Access Immunoassay Systems BR Monitor, and Calibrators, Model (S) 387620,and 387647Summary page 4…n Name: Tumor-associated antigen immunological test system Classification Regulation: (21 CFR 866.6010) Predicate Device: Device Name: Access BR Monitor 510(k) Numbers: k072612, k033036 Device Description The Access BR Monitor assay, Access BR Monitor Calibrators, and the Access Immunoassay analyzers co… | 2007 |
| * | K033036 | BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model 387620…Summary page 4…umor-associated antigen immunological test system Classification Regulation: (21 CFR 866.6010) Predicate Device: Device Name: Access BR Monitor 510(k) Numbers: k072612, k033036 Device Description The Access BR Monitor assay, Access BR Monitor Calibrators, and the Access Immunoassay analyzers comprise th… | 2004 |
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 2 companies; a new generation was cleared every 6.4 years on median.
- 3 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K072612.
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?
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 (heparin) 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 CA 15-3 antigen concentrations should be used in conjunction with other clinical methods for monitoring breast cancer.
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/K240403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240403: Access BR Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240403
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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