510(k) · Cleared
ClearedVitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range Verifiers
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 17, 2004 as substantially equivalent to K990943 (Ortho-Clinical Diagnostics, Inc., 1999) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Jun 17, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- DHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K973517 (1997). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK973517 Vitros Immunodiagnostic Products Range VerifiersJohnson & Johnson Clinical Diagnostics, Inc. · 1997
- 1 generation backK990984 Vitros Immunodiagnostic Products Cea Range VerifiersOrtho-Clinical Diagnostics, Inc. · 1999
- This deviceK041322 Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range…Ortho-Clinical Diagnostics, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK231517 VITROS Immunodiagnostic Products CEA Reagent PackOrtho Clinical Diagnostics · 2023
Most influential descendants
Showing 1 of 1 · See all- K231517VITROS Immunodiagnostic Products CEA Reagent PackOrtho Clinical Diagnostics · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973517 | Vitros Immunodiagnostic Products Range Verifiers | Johnson & Johnson Clinical Diagnostics, Inc. | 1997 | — |
| −1 | K990984 | Vitros Immunodiagnostic Products Cea Range Verifiers | Ortho-Clinical Diagnostics, Inc. | 1999 | — |
| 0 (this device) | K041322 | Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range Verifiers | Ortho-Clinical Diagnostics, Inc. | 2004 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 6.7 · 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990943 | Vitros Immunodiagnostic Products Cea Calibrators, Vitros Immunodiagnostic Products Cea…Summary page 2…VITROS Immunodiagnostic Products CEA Reagent Pack, VITROS Immunodiagnostic Products CEA Calibrators (both cleared under K990943), and VITROS Immunodiagnostic Products CEA Range Verifiers (K990984) which are combined by the… | 1999 |
| * | K990984 | Vitros Immunodiagnostic Products Cea Range VerifiersSummary page 2…nostic Products CEA Calibrators (both cleared under K990943), and VITROS Immunodiagnostic Products CEA Range Verifiers (K990984) which are combined by the VITROS Immunodiagnostic System to perform the VITROS CEA… | 1999 |
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 |
|---|---|---|---|
| K231517 | VITROS Immunodiagnostic Products CEA Reagent Pack | 2023 | 0 |
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 7 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K231517 (Ortho Clinical Diagnostics, 2023) 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?
VITROS Immunodiagnostic Products CEA Reagent Pack For in vitro diagnostic use only. The VITROS CEA Reagent Pack quantitatively measures carcinoembryonic antigen (CEA) concentration in human serum and plasma to aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed. VITROS Immunodiagnostic Products CEA Calibrators For in vitro use in the calibration of the VITROS Immunodiagnostic System for the…
Read the full statement (103 words)
VITROS Immunodiagnostic Products CEA Reagent Pack
For in vitro diagnostic use only.
The VITROS CEA Reagent Pack quantitatively measures carcinoembryonic antigen (CEA) concentration in human serum and plasma to aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed.
VITROS Immunodiagnostic Products CEA Calibrators
For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of CEA in serum and plasma (EDTA or heparin).
VITROS Immunodiagnostic Products CEA Range Verifiers
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of CEA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041322 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041322: Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range Verifiers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041322
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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