510(k) · Cleared
Recalled · Class II · 2021Chiron Diagnostics Corporation Acs: Centaur BR Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chiron Diagnostics Corp. · MOI System, Test, Immunological, Antigen, Tumor
Cleared on Oct 15, 1998 as substantially equivalent to K981698 (Chiron Corp., 1998) after a 76-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it. It has been recalled 9 times.
- Decided
- Oct 15, 1998
- Review
- 76 days
- Class
- Class II
- Product code
- MOI
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981698 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK981698 Acs:180 BR (Automated Chemiluminescence System for the Quantitation…Chiron Corp. · 1998
- This deviceK982680 Chiron Diagnostics Corporation Acs: Centaur BR ImmunoassayChiron Diagnostics Corp. · 1998
- Descendant · cites it directly · 0 of its ownK193489 ADVIA Centaur BRSiemens Healthcare Diagnostics, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K193489ADVIA Centaur BRSiemens Healthcare Diagnostics, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981698 | Acs:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer… | Chiron Corp. | 1998 | — |
| 0 (this device) | K982680 | Chiron Diagnostics Corporation Acs: Centaur BR Immunoassay | Chiron Diagnostics Corp. | 1998 | — |
| +1 | K193489 | ADVIA Centaur BR | Siemens Healthcare Diagnostics, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K981698 | Acs:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer Antigen…Summary page 1…ame: Reclassified to Class |l, classification number unknown Predicate Device Information Name: ACS:180 BR Immunoassay Manufacturer: Chiron Diagnostics 510(k) Number: K981698 Statement of Intended Use The Chiron Diagnostics ACS:Centaur BR assay is an in vitro diagnostic test for the quantitative seria… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193489 | ADVIA Centaur BR | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 6, 2021 | Class II | Z-2426-2021 | Under Investigation by firm | Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers |
| Jul 6, 2021 | Class II | Z-2424-2021 | Under Investigation by firm | Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers |
| Jul 6, 2021 | Class II | Z-2425-2021 | Under Investigation by firm | Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers |
| Mar 8, 2017 | Class II | Z-1747-2017 | Under Investigation by firm | Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems |
| Mar 8, 2017 | Class II | Z-1749-2017 | Under Investigation by firm | Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems |
| Mar 8, 2017 | Class II | Z-1748-2017 | Under Investigation by firm | Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems |
| Nov 14, 2012 | Class II | Z-0512-2013 | Device Design | Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used. |
| Nov 14, 2012 | Class II | Z-0507-2013 | Device Design | Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used. |
| Sep 11, 2012 | Class II | Z-0162-2013 | Under Investigation by firm | BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K193489 (Siemens Healthcare Diagnostics, Inc., 2020) has gone furthest, with 0 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 Chiron Diagnostics ACS:Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the Chiron Diagnostics ACS:Centaur” Automated Chemiluminescence System. The test is intended for use as an aid in monitoring patients previously treated for Stage Il or Stage il breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be…
Read the full statement (120 words)
The Chiron Diagnostics ACS:Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the Chiron Diagnostics ACS:Centaur” Automated Chemiluminescence System. The test is intended for use as an aid in monitoring patients previously treated for Stage Il or Stage il breast cancer. Serial testing for CA 27.29 in the serum 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982680 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982680: Chiron Diagnostics Corporation Acs: Centaur BR Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982680
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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