510(k) · Cleared
ClearedVitros Immunodiagnostic Products Cea Calibrators, Vitros 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, Inc. · DHX System, Test, Carcinoembryonic Antigen
Cleared on Jun 1, 1999 after a 71-day review; its predicate, P830066, is listed below. 2 later devices descend from it.
- Decided
- Jun 1, 1999
- Review
- 71 days
- Class
- Class II
- Product code
- DHX
- Recalls
- None
- Predicates
- 1
1 ancestor in all. 2 later devices descend from it, 1 citing it directly.
- This deviceK990943 Vitros Immunodiagnostic Products Cea Calibrators, Vitros…Ortho-Clinical Diagnostics, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK041322 Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range…Ortho-Clinical Diagnostics, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK231517 VITROS Immunodiagnostic Products CEA Reagent PackOrtho Clinical Diagnostics · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990943 | Vitros Immunodiagnostic Products Cea Calibrators, Vitros Immunodiagnostic… | Ortho-Clinical Diagnostics, Inc. | 1999 | — |
| +1 | K041322 | Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range Verifiers | Ortho-Clinical Diagnostics, Inc. | 2004 | — |
| +2 | K231517 | VITROS Immunodiagnostic Products CEA Reagent Pack | Ortho Clinical Diagnostics | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | P830066 | Cea-Ria Monoclonal FDA lists this PMA only through its supplements; the earliest we hold is P830066/S001 (Aug 21, 1984). Summary page 1…inoembyronic antigen in serum or plasma. 3. Predicate Device The VITROS Immunodiagnostic Products CEA assay is substantially equivalent to the Abbott AXxSYM CEA Assay (P830066). 4. Device Description The VITROS ECi Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-qua… |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041322 | Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range Verifiers | 2004 | 1 |
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?
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?
The Vitros® CEA is an in vitro assay intended for the quantitative measurement of carcinoembryonic antigen (CEA) in human serum and plasma (EDTA or heparin) to aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed.
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/K990943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990943: Vitros Immunodiagnostic Products Cea Calibrators, 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/K990943
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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