510(k) · Cleared
Recalled · Class II · 2015Access Cea Reagents for Use on the Access Immunoassay Systems
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 May 6, 2003 as substantially equivalent to K981985 (Beckman Coulter, Inc., 1998) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it. It has been recalled once.
- Decided
- May 6, 2003
- Review
- 15 days
- Class
- Class II
- Product code
- DHX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K981985 (1998). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK981985 Access Cea Reagents on the Access Immunoassay Analyzer Model 33200…Beckman Coulter, Inc. · 1998 · Recalled
- 1 generation backK991707 Modification to Access Cea Reagents for Use on the Access…Beckman · 1999
- This deviceK031270 Access Cea Reagents for Use on the Access Immunoassay SystemsBeckman Coulter, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK071603 Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK100321 Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions…Siemens Healthcare Diagnostics · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981985 | Access Cea Reagents on the Access Immunoassay Analyzer Model 33200, 33205… | Beckman Coulter, Inc. | 1998 | 1 |
| −1 | K991707 | Modification to Access Cea Reagents for Use on the Access Immunoassay… | Beckman | 1999 | — |
| 0 (this device) | K031270 | Access Cea Reagents for Use on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2003 | — |
| +1 | K071603 | Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea) | Dade Behring, Inc. | 2008 | — |
| +2 | 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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 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 6.6 · 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? (3)
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 |
|---|---|---|---|
| * | K981985 | Access Cea Reagents on the Access Immunoassay Analyzer Model 33200, 33205, 33206 & 33209Summary page 1…t of Cancers Device Class Class II Legally Marketed Access0 CEA Reagents on the AccessB (Unmodified) Device Analyzer (K981985, cleared 09/24/98; K991707, cleared 06/01/99; Access 2 Add-to-File Letter, dated 04/24/91) De… | 1998 |
| * | K991707 | Modification to Access Cea Reagents for Use on the Access Immunoassay Analyzer, Models…Summary page 1…Class II Legally Marketed Access0 CEA Reagents on the AccessB (Unmodified) Device Analyzer (K981985, cleared 09/24/98; K991707, cleared 06/01/99; Access 2 Add-to-File Letter, dated 04/24/91) Device Description The Access… | 1999 |
| * | — | Access 2 Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071603 | Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea) | 2008 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 13, 2015 | Class II | Z-0239-2016 | Under Investigation by firm | Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K071603 (Dade Behring, Inc., 2008) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K981985.
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) levels in human serum, using the Access Immunoassay Systems. CEA measured by the Access Immunoassay Systems is used as an aid in the management of cancer patients in whom changing CEA concentrations have been observed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031270 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031270: Access Cea Reagents for Use on the Access Immunoassay Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031270
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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