510(k) · Cleared
Recalled · Class II · 2018ST Aia-Pack Cea Enzyme Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tosoh Medics, Inc. · DHX System, Test, Carcinoembryonic Antigen
Cleared on Dec 18, 2002 after a 26-day review. The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below). 1 later device descends from it. It has been recalled once.
- Decided
- Dec 18, 2002
- Review
- 26 days
- Class
- Class II
- Product code
- DHX
- Recalls
- 1
- Predicates
- 2
1 later device descends from it, 1 citing it directly.
- This deviceK023893 ST Aia-Pack Cea Enzyme ImmunoassayTosoh Medics, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK080194 Vidas Cea (S) AssaybioMerieux, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K080194Vidas Cea (S) AssaybioMerieux, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023893 | ST Aia-Pack Cea Enzyme Immunoassay | Tosoh Medics, Inc. | 2002 | — |
| +1 | K080194 | Vidas Cea (S) Assay | bioMerieux, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (2)
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 | P910053 | Tosoh AIA-PACK CEA 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…Tosoh Corporation Tokyo, Japan P910053 Device Description: The ST AIA-PACK CEA is a two-site immunoenzymometric assay which is performed en… | |
| Kept off the family tree | P910006 | Aia-Pack Cea 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 2…ication in the packaging, incubation period, conjugate concentration and certain components of the conjugate diluent of the AIA-PACK CEA, which was previously cleared as P910006 on February 19, 1993. The intended use, assay principles, antibody type, analyte detected, and performance characteristics of bot… |
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 |
|---|---|---|---|
| K080194 | Vidas Cea (S) Assay | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2018 | Class II | Z-2066-2018 | Device Design | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K080194 (bioMerieux, Inc., 2008) 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?
ST AIA-PACK CEA is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Carcinoembryonic Antigen (CEA) in human serum to aid in the management of cancer patients in whom changing concentrations of CEA are observed on specific TOSOH AIA System Analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023893: ST Aia-Pack Cea Enzyme Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023893
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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