510(k) · Cleared
Recalled · Class II · 2017Access Immunoassay Systems BR Monitor, and Calibrators, Model (S) 387620,and 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 Oct 26, 2007 as substantially equivalent to K033036 (Beckman Coulter, Inc., 2004) after a 39-day review. Its family tree reaches back 2 generations to 1997. 3 later devices descend from it. It has been recalled once.
- Decided
- Oct 26, 2007
- Review
- 39 days
- Class
- Class II
- Product code
- MOI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963926 (1997). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK963926 Axsym CA 15-3Abbott Laboratories · 1997 · Recalled
- 1 generation backK033036 BR Monitor and BR Monitor Calibrators on the Access Immunoassay…Beckman Coulter, Inc. · 2004 · Recalled
- This deviceK072612 Access Immunoassay Systems BR Monitor, and Calibrators, Model (S)…Beckman Coulter, Inc. · 2007
- Descendant · cites it directly · 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 · 2 generations on · 0 of its ownK122398 Rapidpoint 500 System Measurement Cartridge with CalibratorsSiemens Healthcare Diagnostics, Inc. · 2012 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K100344Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator…Siemens Healthcare Diagnostics · 2011 · cites it directly1descendant
- K240403Access BR MonitorBeckman Coulter, Inc. · 2024 · cites it directly0descendants
- K122398Rapidpoint 500 System Measurement Cartridge with CalibratorsSiemens Healthcare Diagnostics, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963926 | Axsym CA 15-3 | Abbott Laboratories | 1997 | 4 |
| −1 | K033036 | BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model… | Beckman Coulter, Inc. | 2004 | 1 |
| 0 (this device) | K072612 | Access Immunoassay Systems BR Monitor, and Calibrators, Model (S) 387620,and… | Beckman Coulter, Inc. | 2007 | — |
| +1 | 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 | — |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K033036 | BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model 387620…Summary page 1…ssay for the determination of CA 15-3 antigen Product classification: Class 11 Product code: MOI, JIT Predicate device: Access BR Monitor Assay - K033036 Device description: The Access BR Monitor assay and the Access Immunoassay Analyzers comprise th… | 2004 |
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 |
|---|---|---|---|---|
| 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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K100344 (Siemens Healthcare Diagnostics, 2011) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K033036.
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. 2007, 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 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.
The Access BR Monitor Calibrators are intended to calibrate the Access BR Monitor assay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma using the Access Immunoassay Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072612 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072612: Access Immunoassay Systems BR Monitor, and Calibrators, Model (S) 387620,and 387647.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072612
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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