510(k) · Cleared
Recalled · 2007Axsym CA 15-3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · MOI System, Test, Immunological, Antigen, Tumor
Cleared on Sep 15, 1997 after a 350-day review. The FDA summary names its predicate without a number. 7 later devices descend from it. It has been recalled 4 times.
- Decided
- Sep 15, 1997
- Review
- 350 days
- Class
- Class II
- Product code
- MOI
- Recalls
- 4
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK963926 Axsym CA 15-3Abbott Laboratories · 1997
- Descendant · cites it directly · 4 of its ownK033036 BR Monitor and BR Monitor Calibrators on the Access Immunoassay…Beckman Coulter, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 3 of its ownK072612 Access Immunoassay Systems BR Monitor, and Calibrators, Model (S)…Beckman Coulter, Inc. · 2007 · Recalled
- Descendant · 3 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 · 1 of its ownK042732 Architect CA 15-3 AssayFujirebio Diagnostics,Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK240403 Access BR MonitorBeckman Coulter, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K033036BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model 387620…Beckman Coulter, Inc. · 2004 · cites it directly4descendants
- K072612Access Immunoassay Systems BR Monitor, and Calibrators, Model (S) 387620,and 387647Beckman Coulter, Inc. · 2007 · 2 generations on3descendants
- K100344Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator…Siemens Healthcare Diagnostics · 2011 · 3 generations on1descendant
- K042732Architect CA 15-3 AssayFujirebio Diagnostics,Inc. · 2004 · cites it directly1descendant
- K240403Access BR MonitorBeckman Coulter, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963926 | Axsym CA 15-3 | Abbott Laboratories | 1997 | — |
| +1 | K033036 | BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model… | Beckman Coulter, Inc. | 2004 | 1 |
| +2 | K072612 | Access Immunoassay Systems BR Monitor, and Calibrators, Model (S) 387620,and… | Beckman Coulter, Inc. | 2007 | 1 |
| +3 | K100344 | Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7… | Siemens Healthcare Diagnostics | 2011 | 1 |
| +1 | K042732 | Architect CA 15-3 Assay | Fujirebio Diagnostics,Inc. | 2004 | — |
| +2 | K240403 | Access BR Monitor | Beckman Coulter, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | — | BIOMIRA Diagnostics Inc. TRUQUANT® BR™ RIA assay Named without a submission number |
What descends from it? (7)
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 23, 2007 | Not classified | Z-1027-2007 | Other | Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument. |
| Jun 9, 2006 | Not classified | Z-1244-06 | Other | The CA 15-3 Controls replicates out of range high resulting in invalid runs. |
| Mar 4, 2003 | Not classified | Z-0679-03 | Other | The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens. |
| Mar 4, 2003 | Not classified | Z-0680-03 | Other | The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033036 (Beckman Coulter, Inc., 2004) has gone furthest, with 4 descendants of its own.
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 AxSYM® CA 15-3™ assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of CA 15-3 assay values in human serum and plasma (EDTA) to aid in the management of breast cancer patients. Serial testing for patient CA 15-3 assay values 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/K963926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963926: Axsym CA 15-3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963926
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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