510(k) · Cleared
ClearedVITROS Immunodiagnostic Products CEA Reagent Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Clinical Diagnostics · DHX System, Test, Carcinoembryonic Antigen
Cleared on Aug 23, 2023 as substantially equivalent to K041322 (Ortho-Clinical Diagnostics, Inc., 2004) after a 90-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Aug 23, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- DHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K973517 (1997). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK973517 Vitros Immunodiagnostic Products Range VerifiersJohnson & Johnson Clinical Diagnostics, Inc. · 1997
- 2 generations backK990984 Vitros Immunodiagnostic Products Cea Range VerifiersOrtho-Clinical Diagnostics, Inc. · 1999
- 1 generation backK041322 Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range…Ortho-Clinical Diagnostics, Inc. · 2004
- This deviceK231517 VITROS Immunodiagnostic Products CEA Reagent PackOrtho Clinical Diagnostics · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K973517 | Vitros Immunodiagnostic Products Range Verifiers | Johnson & Johnson Clinical Diagnostics, Inc. | 1997 | — |
| −2 | K990984 | Vitros Immunodiagnostic Products Cea Range Verifiers | Ortho-Clinical Diagnostics, Inc. | 1999 | — |
| −1 | K041322 | Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range Verifiers | Ortho-Clinical Diagnostics, Inc. | 2004 | — |
| 0 (this device) | K231517 | VITROS Immunodiagnostic Products CEA Reagent Pack | Ortho Clinical Diagnostics | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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
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 |
|---|---|---|---|
| * | K041322 | Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range VerifiersSummary page 4…Predicate Device FDA 510(k) Number VITROS Immunodiagnostic Products CEA Reagent Pack K041322 Device Description The VITROS Immunodiagnostic Products CEA Reagent Pack (test) is performed using the VITROS CEA Reagent Pack an… | 2004 |
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?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 4 ancestors 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. 2023, 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?
For In Vitro Diagnostic Use Only
For the quantitative measurement of carcinoembryonic antigen (CEA) concentration in human serum and plasma (EDTA or heparin) using the VITROS 5600 Integrated System, to aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231517: VITROS Immunodiagnostic Products CEA Reagent Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231517
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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