510(k) · Cleared
ClearedADVIA Centaur BR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · MOI System, Test, Immunological, Antigen, Tumor
Cleared on Feb 13, 2020 as substantially equivalent to K982680 (Chiron Diagnostics Corp., 1998) after a 58-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Feb 13, 2020
- Review
- 58 days
- Class
- Class II
- Product code
- MOI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K981698 (1998). No later device cites it as a predicate yet.
- Root · 2 generations backK981698 Acs:180 BR (Automated Chemiluminescence System for the Quantitation…Chiron Corp. · 1998
- 1 generation backK982680 Chiron Diagnostics Corporation Acs: Centaur BR ImmunoassayChiron Diagnostics Corp. · 1998 · Recalled
- This deviceK193489 ADVIA Centaur BRSiemens Healthcare Diagnostics, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981698 | Acs:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer… | Chiron Corp. | 1998 | — |
| −1 | K982680 | Chiron Diagnostics Corporation Acs: Centaur BR Immunoassay | Chiron Diagnostics Corp. | 1998 | 9 |
| 0 (this device) | K193489 | ADVIA Centaur BR | Siemens Healthcare Diagnostics, Inc. | 2020 | — |
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 |
|---|---|---|---|
| * | K982680 | Chiron Diagnostics Corporation Acs: Centaur BR ImmunoassaySummary page 4…MOI Regulation Number 21 CFR 866.6010 4. Predicate Device Information Predicate Device Name: ADVIA Centaur® BR 510(k) Number: K982680 The ADVIA Centaur BR assay with the addition of the plasma (EDTA) sample and detection capability [Limit of Blank (LoB), Limit of… | 1998 |
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 22 years and passes through 3 companies; a new generation was cleared every 21.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
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. 2020, 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 ADVIA Centaur® BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the ADVIA Centaur®, ADVIA Centaur XP, and ADVIA Centaur XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum and plasma of patients who are clinically free of disease…
Read the full statement (128 words)
The ADVIA Centaur® BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the ADVIA Centaur®, ADVIA Centaur XP, and ADVIA Centaur XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum and plasma of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193489 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193489: ADVIA Centaur BR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193489
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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