510(k) · Cleared
Recalled · Class II · 2014Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer
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 Jul 17, 1997 as substantially equivalent to K902336 (Ciba Corning Diagnostics Corp., 1990) after a 92-day review. Its family tree reaches back 1 generation to 1990. 21 later devices descend from it. It has been recalled 4 times.
- Decided
- Jul 17, 1997
- Review
- 92 days
- Class
- Class II
- Product code
- MOI
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902336 (1990). 21 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK902336 Ciba Corning Acs:180 Automated ChemiluminescenceCiba Corning Diagnostics Corp. · 1990
- This deviceK971418 Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur…Chiron Diagnostics Corp. · 1997
- Descendant · cites it directly · 18 of its ownK032525 Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC · 2003
- Descendant · 2 generations on · 17 of its ownK041133 Modification to Bayer Advia Centaur Automated Chemiluminescence…Bayer Healthcare, LLC · 2004 · Recalled
- Descendant · 3 generations on · 4 of its ownK151792 Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH…Siemens Healthcare Diagnostics, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 4 of its ownK082638 Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 4 of its ownK071224 Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and…Dade Behring, Inc. · 2007 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K032525Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC · 2003 · cites it directly18descendants
- K041133Modification to Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC · 2004 · 2 generations on17descendants
- K151792Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators…Siemens Healthcare Diagnostics, Inc. · 2015 · 3 generations on4descendants
- K082638Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc. · 2009 · 3 generations on4descendants
- K071224Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 CalibratorDade Behring, Inc. · 2007 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902336 | Ciba Corning Acs:180 Automated Chemiluminescence | Ciba Corning Diagnostics Corp. | 1990 | — |
| 0 (this device) | K971418 | Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer | Chiron Diagnostics Corp. | 1997 | — |
| +1 | K032525 | Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2003 | — |
| +2 | K041133 | Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2004 | 8 |
| +3 | K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH… | Siemens Healthcare Diagnostics, Inc. | 2015 | 22 |
| +3 | K082638 | Advia Centaur System with Streamlab Analytical Workcell | Siemens Healthcare Diagnostics, Inc. | 2009 | 3 |
| +3 | K071224 | Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4… | Dade Behring, Inc. | 2007 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K902336 | Ciba Corning Acs:180 Automated ChemiluminescenceSummary page 1…| 3. Predicate Device Information Name: ACS:180® Analyzer Manufacturer: Chiron Diagnostics Corporation (formally Ciba Corning Diagnostics Corp.) 510(k) Number: D.C. #K902336. 4. Device Description The ACS:Centaur system is a stand-alone, continuous operation, immunochemistry analyzer. The system perf… | 1990 |
What descends from it? (21)
See all 212 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 |
|---|---|---|---|---|
| Feb 18, 2014 | Class II | Z-1553-2014 | Device Design | Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This may lead to the cover falling. |
| Jan 12, 2008 | Not classified | Z-1119-2008 | Nonconforming Material/Component | Incorrect results: False reactive specimens on the ADVIA Centaur HAV IgM assay. |
| Nov 9, 2006 | Not classified | Z-0645-2007 | Other | Firm received complaints for signal 2 & 4 errors, and shifts in Relative Light Units (RLU). Investigations showed that the On-Board Stability (OBS) of the acid & base reagents may be compromised after 4 days after installation onto the… |
| Aug 4, 2006 | Not classified | Z-1516-06 | Software design | Sample/Patient mis-identification (software defect)-the system can associate a test result and sample identification (SID) with an incorrect patient name when the Patient Demographics feature is used and the Patient Identification (PID)… |
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 intended use of the ACS:Centaur system is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assays analysis on clinical specimens using the ACS iimmunoassays. The system menu will include endocrine, anemia, reproductive, cardiac, therapeutic drug, and infectious disease assays. All assays are based on chemiluminescent technology.proteins and is an indirect indicator of thyroid status.4
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/K971418 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971418: Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971418
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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