PMA · Approved
Recalled · 2007Abbott Afp-Eia Diagnostic Kit for Cancer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
Approved on Jun 21, 1983 through premarket approval, which rests on the device’s own clinical evidence after a 312-day review. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 21, 1983
- Review
- 312 days
- Class
- Class III
- Product code
- LOK
- Recalls
- 2
7 later devices descend from it, 4 citing it directly.
- This deviceP820060 Abbott Afp-Eia Diagnostic Kit for CancerAbbott Laboratories · 1983
- Descendant · cites it directly · 3 of its ownK981354 Access Afp Reagents on the Access Immunoassay Analyzer Model Number…Beckman Instruments, Inc. · 1998 · Recalled
- Descendant · cites it directly · 2 of its ownK071597 Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454…Dade Behring, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK983031 Vitros Immunodiagnostic Products Afp AssayOrtho-Clinical Diagnostics, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 0 of its ownK213626 Vitros AfpOrtho Clinical Diagnostics · 2022
- Descendant · 2 generations on · 0 of its ownK100321 Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions…Siemens Healthcare Diagnostics · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K981354Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211Beckman Instruments, Inc. · 1998 · cites it directly3descendants
- K071597Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R)…Dade Behring, Inc. · 2008 · cites it directly2descendants
- K983031Vitros Immunodiagnostic Products Afp AssayOrtho-Clinical Diagnostics, Inc. · 1998 · cites it directly1descendant
- K213626Vitros AfpOrtho Clinical Diagnostics · 2022 · 2 generations on0descendants
- K100321Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6 Cal…Siemens Healthcare Diagnostics · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P820060 | Abbott Afp-Eia Diagnostic Kit for Cancer | Abbott Laboratories | 1983 | — |
| +1 | K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211 | Beckman Instruments, Inc. | 1998 | 1 |
| +1 | K071597 | Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension… | Dade Behring, Inc. | 2008 | — |
| +1 | K983031 | Vitros Immunodiagnostic Products Afp Assay | Ortho-Clinical Diagnostics, Inc. | 1998 | 1 |
| +2 | K213626 | Vitros Afp | Ortho Clinical Diagnostics | 2022 | — |
| +2 | K100321 | Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6… | Siemens Healthcare Diagnostics | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LOK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211 | 1998 | 3 |
| K071597 | Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R)… | 2008 | 2 |
| K983031 | Vitros Immunodiagnostic Products Afp Assay | 1998 | 1 |
| K983263 | Immulite Afp, Model Lkapi, LKAP5, Immulite 2000 Afp, Model L2KAP2 | 1998 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 18, 2007 | Not classified | Z-0299-2008 | Software design | The lower limit flag for auto-dilution protocol 3 (amniotic fluid) was set too low (15 ng/mL) for the ARCHITECT AFP assay file for the ARCHITECT AFP non-U.S. product. The assay labeling indicates that the limit flag should be set no lower… |
| Mar 4, 2003 | Not classified | Z-0726-03 | Other | The IMx AFP Calibrators may cause depressed values for the IMx AFP Low Control, and cause patient results to be 20% lower than actual values |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K981354 (Beckman Instruments, Inc., 1998) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LOK devicesLOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LOK
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LOK
Too few LOK 510(k)s in any year since 2007 to give a median.
Recalls per year · LOK
No recall names LOK since 2007.
Adverse event reports per year · LOK
18in 2025
MAUDE reports naming product code LOK, 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 | 3 | — | 0 | 0 |
| 2008 | 4 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 3 | — | 0 | 1 |
| 2011 | 14 | — | 0 | 0 |
| 2012 | 11 | — | 0 | 5 |
| 2013 | 11 | — | 0 | 6 |
| 2014 | 6 | — | 0 | 12 |
| 2015 | 5 | — | 0 | 2 |
| 2016 | 3 | — | 0 | 4 |
| 2017 | 6 | — | 0 | 11 |
| 2018 | 8 | — | 0 | 17 |
| 2019 | 6 | — | 0 | 18 |
| 2020 | 15 | — | 0 | 10 |
| 2021 | 8 | — | 0 | 15 |
| 2022 | 6 | — | 0 | 10 |
| 2023 | 9 | — | 0 | 11 |
| 2024 | 4 | — | 0 | 5 |
| 2025 | 5 | — | 0 | 18 |
| 2026 | 7 | — | 0 | — |
https://510kreport.com/device/P820060 · printed Nov 6, 2026
Cite this page
510(k) Report. “P820060: Abbott Afp-Eia Diagnostic Kit for Cancer.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P820060
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026