510(k) · Cleared
ClearedCA 15-3 Assay for the Advia Centaur System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Diagnostics Corp. · MOI System, Test, Immunological, Antigen, Tumor
Cleared on Feb 28, 2002 as substantially equivalent to K964703 (Bayer Corp., 1997) after a 218-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it.
- Decided
- Feb 28, 2002
- Review
- 218 days
- Class
- Class II
- Product code
- MOI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964703 (1997). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK964703 The CA 15-3 Assay for the Technicon Immuno 1 System (in Vitro…Bayer Corp. · 1997
- This deviceK012357 CA 15-3 Assay for the Advia Centaur SystemBayer Diagnostics Corp. · 2002
- 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 ownK192777 ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc. · 2019
- 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
- K192777ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc. · 2019 · 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 |
|---|---|---|---|---|---|
| −1 | K964703 | The CA 15-3 Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System) | Bayer Corp. | 1997 | — |
| 0 (this device) | K012357 | CA 15-3 Assay for the Advia Centaur System | Bayer Diagnostics Corp. | 2002 | — |
| +1 | K100344 | Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7… | Siemens Healthcare Diagnostics | 2011 | 1 |
| +1 | K192777 | ADVIA Centaur CA 15-3 assay | Siemens Healthcare Diagnostics, Inc. | 2019 | — |
| +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 |
| 2019 | 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 |
|---|---|---|---|
| * | K964703 | The CA 15-3 Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System)Summary page 1…ordance with “Guidance Document for Submission of Tumor Associated Antigen Premarket Notifications”. Substantial Equivalence To: Bayer Immuno-1 CA 15-3 510(k) Number: K964703 7.2 7.3 74 7.5 Page 2 of 2 Intended Use The ADVIA Centaur CA 15-3 assay is an in vitro diagnostic test for t… | 1997 |
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)
No FDA recall names this device.
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 ADVIA Centaur CA 15-3 assay is an in vitro diagnostic test for the quantitative
serial determination of cancer antigen CA 15-3 in human serum using the ADVIA
Centaur® System. When used in conjunction with other clinical and diagnostic
procedures, serial testing with the ADVIA Centaur CA 15-3 assay is useful for
monitoring the course of disease and therapy in metastatic breast cancer patients, and
for detection of recurrence in previously treated patients with Stage II, with greater than
two positive lymph nodes, or Stage III breast cancer patients. This assay is not intended
for use on any other system.
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/K012357 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012357: CA 15-3 Assay for the Advia Centaur System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012357
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026