510(k) · Cleared
ClearedDimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · DHX System, Test, Carcinoembryonic Antigen
Cleared on Jun 25, 2008 as substantially equivalent to K031270 (Beckman Coulter, Inc., 2003) after a 379-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- Jun 25, 2008
- Review
- 379 days
- Class
- Class II
- Product code
- DHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K981985 (1998). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK981985 Access Cea Reagents on the Access Immunoassay Analyzer Model 33200…Beckman Coulter, Inc. · 1998 · Recalled
- 2 generations backK991707 Modification to Access Cea Reagents for Use on the Access…Beckman · 1999
- 1 generation backK031270 Access Cea Reagents for Use on the Access Immunoassay SystemsBeckman Coulter, Inc. · 2003 · Recalled
- This deviceK071603 Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK100321 Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions…Siemens Healthcare Diagnostics · 2011
Most influential descendants
Showing 1 of 1 · See all- K100321Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6 Cal…Siemens Healthcare Diagnostics · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981985 | Access Cea Reagents on the Access Immunoassay Analyzer Model 33200, 33205… | Beckman Coulter, Inc. | 1998 | 1 |
| −2 | 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 |
| 0 (this device) | K071603 | Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea) | Dade Behring, Inc. | 2008 | — |
| +1 | 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 |
|---|---|---|
| 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 6.7 · 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 |
|---|---|---|---|
| * | K031270 | Access Cea Reagents for Use on the Access Immunoassay SystemsSummary page 1…gy (82) and Clinical Chemistry (75) 3. Identification of the Legally Marketed Devices: Beckman Access CEA Reagents on the Access Immunoassay System - K031270 4. Device Descriptions: Dimension Vista® CEA Flex ® reagent cartridge The CEA method is a homogeneous, sandw… | 2003 |
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 |
|---|---|---|---|
| K100321 | Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6 Cal… | 2011 | 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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K100321 (Siemens Healthcare Diagnostics, 2011) 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. 2008, this device’s year, is highlighted.
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 CEA method is an in vitro diagnostic test for the quantitative measurement of carcinoembryonic antigen in human serum and sodium or lithium heparin plasma on the Dimension Vista® System. Measurements of carcinoembryonic antigen are used as an aid in the management of cancer patients in whom changing CEA concentrations have been observed.
For the calibration of the Carcinoembryonic Antigen (CEA) method on the Dimension Vista® System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071603 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071603: Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071603
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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