510(k) · Cleared
ClearedVidas Cea (S) Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · DHX System, Test, Carcinoembryonic Antigen
Cleared on Oct 9, 2008 as substantially equivalent to K023893 (Tosoh Medics, Inc., 2002) after a 258-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Oct 9, 2008
- Review
- 258 days
- Class
- Class II
- Product code
- DHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023893 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK023893 ST Aia-Pack Cea Enzyme ImmunoassayTosoh Medics, Inc. · 2002 · Recalled
- This deviceK080194 Vidas Cea (S) AssaybioMerieux, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023893 | ST Aia-Pack Cea Enzyme Immunoassay | Tosoh Medics, Inc. | 2002 | 1 |
| 0 (this device) | K080194 | Vidas Cea (S) Assay | bioMerieux, Inc. | 2008 | — |
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 |
|---|---|---|---|
| * | K023893 | ST Aia-Pack Cea Enzyme ImmunoassaySummary page 2…VIDAS® CEA (5)Assay T TOOH ST MLA-PACK CEA K023893) General Comparison Intended Use VIDASe CEA (5) is an automated ST AlA-PACK CEA is designed for… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has a recall.
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?
VIDAS® CEA (S) is an automated quantitative test for use on the VIDAS instruments, for the quantitative measurement of Carcinoembryonic antigen (CEA) in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CEA (S) assay is indicated as an aid in the monitoring of cancer patients in whom changing concentrations of CEA are observed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080194 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080194: Vidas Cea (S) Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080194
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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