510(k) · Cleared
Recalled · Class II · 2018Immulite Cea
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · DHX System, Test, Carcinoembryonic Antigen
Cleared on Sep 22, 1997 after a 196-day review. The FDA summary names its predicate without a number. It has been recalled 3 times.
- Decided
- Sep 22, 1997
- Review
- 196 days
- Class
- Class II
- Product code
- DHX
- Recalls
- 3
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (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 |
|---|---|---|---|
| * | — | Abbott Laboratories' IMx® CEA Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 2, 2018 | Class II | Z-1678-2018 | Error in labeling | Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the… |
| May 26, 2005 | Not classified | Z-1015-05 | Other | Adverse trend in stability, controls biased or out of range. |
| May 3, 2004 | Not classified | Z-0972-04 | Other | Instabililty |
No ancestor or descendant has a Class I 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.
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?
DPC's IMMULITE CEA is intended for use with the IMMULITE Automated Immunoassay Analyzer. The IMMULITE CEA is a solid-phase, chemiluminescent enzyme immunoassay designed for the quantitative detection of carcinoembryonic antigen in human serum. It is intended strictly for in vitro diagnostic use as an aid in the management of cancer patients and in the assessment of prognosis.
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/K970877 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970877: Immulite Cea.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970877
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026