510(k) · Cleared
Recalled · 2006Access Cea Reagents on the Access Immunoassay Analyzer Model 33200, 33205, 33206 & 33209
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · DHX System, Test, Carcinoembryonic Antigen
Cleared on Sep 24, 1998 after a 111-day review; its predicate, P830066, is listed below. 5 later devices descend from it. It has been recalled once.
- Decided
- Sep 24, 1998
- Review
- 111 days
- Class
- Class II
- Product code
- DHX
- Recalls
- 1
- Predicates
- 1
1 ancestor in all. 5 later devices descend from it, 3 citing it directly.
- This deviceK981985 Access Cea Reagents on the Access Immunoassay Analyzer Model 33200…Beckman Coulter, Inc. · 1998
- Descendant · cites it directly · 4 of its ownK991707 Modification to Access Cea Reagents for Use on the Access…Beckman · 1999
- Descendant · cites it directly · 2 of its ownK031270 Access Cea Reagents for Use on the Access Immunoassay SystemsBeckman Coulter, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 1 of its ownK071603 Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK223921 Access CEABeckman Coulter, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK100321 Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions…Siemens Healthcare Diagnostics · 2011
Most influential descendants
Showing 5 of 5 · See all- K991707Modification to Access Cea Reagents for Use on the Access Immunoassay Analyzer, Models…Beckman · 1999 · cites it directly4descendants
- K031270Access Cea Reagents for Use on the Access Immunoassay SystemsBeckman Coulter, Inc. · 2003 · cites it directly2descendants
- K071603Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008 · 2 generations on1descendant
- K223921Access CEABeckman Coulter, Inc. · 2023 · cites it directly0descendants
- K100321Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6 Cal…Siemens Healthcare Diagnostics · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981985 | Access Cea Reagents on the Access Immunoassay Analyzer Model 33200, 33205… | Beckman Coulter, Inc. | 1998 | — |
| +1 | K991707 | Modification to Access Cea Reagents for Use on the Access Immunoassay… | Beckman | 1999 | — |
| +1 | K031270 | Access Cea Reagents for Use on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2003 | 1 |
| +2 | K071603 | Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea) | Dade Behring, Inc. | 2008 | — |
| +1 | K223921 | Access CEA | Beckman Coulter, Inc. | 2023 | — |
| +3 | K100321 | Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6… | Siemens Healthcare Diagnostics | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2023 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P830066 | Cea-Ria Monoclonal FDA lists this PMA only through its supplements; the earliest we hold is P830066/S001 (Aug 21, 1984). Summary page 1…Date: June 4, 1998 2. Predicate Device Abbott IMx CEA Microparticle Enzyme Immunoassay Abbott Laboratories One Abbott Park Road Abbott Park, IL. 60064-3500 PMA Number: P830066 3. Device Description The ACCESS CEA Immunoassay Reagents and the ACCESS Immunoassay Analyzer comprise the ACCESS Immunoassay Sy… |
What descends from it? (5)
3 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 |
|---|---|---|---|---|
| Apr 12, 2006 | Not classified | Z-1313-06 | Other | Firm has confirmed that the Access CEA Assay may generate decreased values with certain frozen platelet specimens. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 Access® CEA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Carcinoembryonic antigen (CEA) in human serum using the ACCESS Immunoassay System. CEA measured by the AcCESs CEA Immunoassay, is used as an aid in the management of cancer patients.
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/K981985 · printed Nov 3, 2026
Cite this page
510(k) Report. “K981985: Access Cea Reagents on the Access Immunoassay Analyzer Model 33200, 33205, 33206 & 33209.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K981985
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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