510(k) · Cleared
Recalled · 2005Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Cleared on May 1, 1998 as substantially equivalent to P820060 (Abbott Laboratories, 1983) after a 17-day review. Its family tree reaches back 1 generation to 1983. 3 later devices descend from it. It has been recalled once.
- Decided
- May 1, 1998
- Review
- 17 days
- Class
- Class II
- Product code
- LOJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to P820060 (1983). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backP820060 Abbott Afp-Eia Diagnostic Kit for CancerAbbott Laboratories · 1983 · Recalled
- This deviceK981354 Access Afp Reagents on the Access Immunoassay Analyzer Model Number…Beckman Instruments, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK071597 Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454…Dade Behring, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK100321 Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions…Siemens Healthcare Diagnostics · 2011
- Descendant · 2 generations on · 0 of its ownK090236 Dimension Vista Afp Flex Reagent Cartridge, Model 6454Siemens Healthcare Diagnostics · 2009
Most influential descendants
Showing 3 of 3 · See all- K071597Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R)…Dade Behring, Inc. · 2008 · cites it directly2descendants
- K100321Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6 Cal…Siemens Healthcare Diagnostics · 2011 · 2 generations on0descendants
- K090236Dimension Vista Afp Flex Reagent Cartridge, Model 6454Siemens Healthcare Diagnostics · 2009 · 2 generations on0descendants
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) | K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211 | Beckman Instruments, Inc. | 1998 | — |
| +1 | K071597 | Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension… | Dade Behring, Inc. | 2008 | — |
| +2 | K100321 | Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6… | Siemens Healthcare Diagnostics | 2011 | — |
| +2 | K090236 | Dimension Vista Afp Flex Reagent Cartridge, Model 6454 | Siemens Healthcare Diagnostics | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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…55318 Date: April 13, 1998 Predicate Device Abbott IMx AFP immunofluorometric Assay Abbott Laboratories One Abbott Park Road Abbott Park, L 60064-3500 PMA Nu:ater: P820060 Device Description The ACCESS® AFP Immunoassay Reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay S… | 1983 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071597 | Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R)… | 2008 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2005 | Not classified | Z-1388-05 | Other | Pipetting for dil-Alpha-fetoprotein when performed on the Access, Access 2 and Synchron LX i 725 has a potential to create splashing which may cause erroneous results. |
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?
The ACCESS® AFP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination-of alpha-fetoprotein (AFP) in human serum using the ACCESS Immunoassay System. AFP measured by the ACCESS AFP Immunoassay, is used as an aid in the management of patients with nonseminomatous testicular cancer.
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/K981354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981354: Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981354
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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