510(k) · Cleared
Recalled · Class III · 2016Vitros Immunodiagnostic Products Afp Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Cleared on Dec 18, 1998 as substantially equivalent to P820060 (Abbott Laboratories, 1983) after a 109-day review. Its family tree reaches back 1 generation to 1983. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 18, 1998
- Review
- 109 days
- Class
- Class II
- Product code
- LOJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to P820060 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backP820060 Abbott Afp-Eia Diagnostic Kit for CancerAbbott Laboratories · 1983 · Recalled
- This deviceK983031 Vitros Immunodiagnostic Products Afp AssayOrtho-Clinical Diagnostics, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK213626 Vitros AfpOrtho Clinical Diagnostics · 2022
Most influential descendants
Showing 1 of 1 · See all- K213626Vitros AfpOrtho Clinical Diagnostics · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P820060 | Abbott Afp-Eia Diagnostic Kit for Cancer | Abbott Laboratories | 1983 | 2 |
| 0 (this device) | K983031 | Vitros Immunodiagnostic Products Afp Assay | Ortho-Clinical Diagnostics, Inc. | 1998 | — |
| +1 | K213626 | Vitros Afp | Ortho Clinical Diagnostics | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 LOJ? 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 LOJ device
- #1 K220176 Elecsys AFPscore 4.6 · 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 |
|---|---|---|---|
| * | P820060 | Abbott Afp-Eia Diagnostic Kit for CancerSummary page 1…etoprotein test kit for testicular cancer 3. Predicate Device The VITROS Immunodiagnostic Products AFP assay is substantially equivalent to the Abbott AxSYM System AFP (P820060S8). 4. Device Description The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quant… | 1983 |
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 |
|---|---|---|---|
| K213626 | Vitros Afp | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 9, 2016 | Class III | Z-2145-2016 | Nonconforming Material/Component | Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the reaction signal over time potentially resulting in the inability to calibrate and use… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LOJ devicesLOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LOJ
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LOJ
Too few LOJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LOJ
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOJ
5in 2025
MAUDE reports naming product code LOJ, 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 | — | 1 | 1 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 2 | — | 1 | 7 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 18 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
VITROS AFP Reagent Pack - For the in vitro quantitative measurement of alpha-fetoprotein (AFP) in human serum to aid in the management of patients with non-seminomatous testicular cancer.
VITROS AFP Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of AFP in human serum.
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/K983031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983031: Vitros Immunodiagnostic Products Afp Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983031
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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