510(k) · Cleared
ClearedAcs:Centaur Cea
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chiron Diagnostics Corp. · DHX System, Test, Carcinoembryonic Antigen
Cleared on Aug 12, 1998 after a 110-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it.
- Decided
- Aug 12, 1998
- Review
- 110 days
- Class
- Class II
- Product code
- DHX
- Recalls
- None
- Predicates
- 1
1 later device descends from it, 1 citing it directly.
- This deviceK981478 Acs:Centaur CeaChiron Diagnostics Corp. · 1998
- Descendant · cites it directly · 0 of its ownK200215 ADVIA Centaur CEA AssaySiemens Healthcare Disgnostics, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200215ADVIA Centaur CEA AssaySiemens Healthcare Disgnostics, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981478 | Acs:Centaur Cea | Chiron Diagnostics Corp. | 1998 | — |
| +1 | K200215 | ADVIA Centaur CEA Assay | Siemens Healthcare Disgnostics, 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 DHX? 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 DHX device
- #1 K223921 Access CEAscore 6.7 · 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | P930017 | ACS:180 CEA Immunoassay Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…e: Reclassified to Class I, classification number unknown 3. Predicate Device Information Name: ACS:180 CEA Immunoassay Manufacturer: Chiron Diagnostics 510(k) Number: P930017 (note reclassified to class I1) 4. Device Description The Chiron Diagnostics ACS:Centaur CEA immunoassay is a two-site immunoas… |
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 |
|---|---|---|---|
| K200215 | ADVIA Centaur CEA Assay | 2020 | 0 |
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?
- Of its descendants, K200215 (Siemens Healthcare Disgnostics, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DHX devicesDHX System, Test, Carcinoembryonic Antigen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DHX
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DHX
Too few DHX 510(k)s in any year since 2007 to give a median.
Recalls per year · DHX
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHX
19in 2025
MAUDE reports naming product code DHX, 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 | 0 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 11 |
| 2009 | 1 | — | 0 | 20 |
| 2010 | 0 | — | 1 | 8 |
| 2011 | 0 | — | 0 | 14 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 26 |
| 2014 | 0 | — | 0 | 15 |
| 2015 | 0 | — | 1 | 33 |
| 2016 | 0 | — | 0 | 22 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 20 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 1 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 2 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 19 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Chiron Diagnostics ACS:Centaur CEA Immunoassay is for the quantitative determination of
carcinoembryonic antigen in serum to aid in the management of cancer patients in whom
changing concentrations of CEA are observed using the Chiron Diagnostics ACS:Centaur
Automated Chemiluminescence Systems.
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/K981478 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981478: Acs:Centaur Cea.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981478
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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