PMA · Approved
ApprovedAccess Afp Immunoassay System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
Approved on Feb 8, 1999 through premarket approval, which rests on the device’s own clinical evidence after a 115-day review. 7 later devices descend from it.
- Decided
- Feb 8, 1999
- Review
- 115 days
- Class
- Class III
- Product code
- LOK
- Recalls
- None
7 later devices descend from it, 1 citing it directly.
- This deviceP980041 Access Afp Immunoassay SystemBeckman Coulter, Inc. · 1999
- Descendant · cites it directly · 6 of its ownK023764 Unicel Dxi 800 Access Immunoassay System, Model 973100Beckman Coulter, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 4 of its ownK090588 Power Processor Sample Processing System with Generic Connection…Beckman Coulter, Inc. · 2009
- Descendant · 3 generations on · 3 of its ownK110413 Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc. · 2011 · Recalled
- Descendant · 4 generations on · 1 of its ownK140496 Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate…Beckman Coulter, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK190298 DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access…Beckman Coulter Biomedical GmbH · 2019 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K023764Unicel Dxi 800 Access Immunoassay System, Model 973100Beckman Coulter, Inc. · 2003 · cites it directly6descendants
- K090588Power Processor Sample Processing System with Generic Connection Module, Model: 4210Beckman Coulter, Inc. · 2009 · 2 generations on4descendants
- K110413Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc. · 2011 · 3 generations on3descendants
- K140496Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access…Beckman Coulter, Inc. · 2014 · 4 generations on1descendant
- K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH…Beckman Coulter Biomedical GmbH · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P980041 | Access Afp Immunoassay System | Beckman Coulter, Inc. | 1999 | — |
| +1 | K023764 | Unicel Dxi 800 Access Immunoassay System, Model 973100 | Beckman Coulter, Inc. | 2003 | 31 |
| +2 | K090588 | Power Processor Sample Processing System with Generic Connection Module… | Beckman Coulter, Inc. | 2009 | — |
| +3 | K110413 | Power Processor Sample Processing System with Generic Connections | Beckman Coulter, Inc. | 2011 | 2 |
| +4 | K140496 | Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access… | Beckman Coulter, Inc. | 2014 | 4 |
| +2 | K190298 | DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate… | Beckman Coulter Biomedical GmbH | 2019 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 2 | 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)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023764 | Unicel Dxi 800 Access Immunoassay System, Model 973100 | 2003 | 6 |
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?
- Of its descendants, K023764 (Beckman Coulter, Inc., 2003) has gone furthest, with 6 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/P980041 · printed Nov 6, 2026
Cite this page
510(k) Report. “P980041: Access Afp Immunoassay System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P980041
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026