510(k) · Cleared
ClearedDimension Vista Afp Flex Reagent Cartridge, Model 6454
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Cleared on Apr 27, 2009 as substantially equivalent to K071597 (Dade Behring, Inc., 2008) after an 84-day review. Its family tree reaches back 3 generations to 1983.
- Decided
- Apr 27, 2009
- Review
- 84 days
- Class
- Class II
- Product code
- LOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P820060 (1983). No later device cites it as a predicate yet.
- Root · 3 generations backP820060 Abbott Afp-Eia Diagnostic Kit for CancerAbbott Laboratories · 1983 · Recalled
- 2 generations backK981354 Access Afp Reagents on the Access Immunoassay Analyzer Model Number…Beckman Instruments, Inc. · 1998 · Recalled
- 1 generation backK071597 Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454…Dade Behring, Inc. · 2008
- This deviceK090236 Dimension Vista Afp Flex Reagent Cartridge, Model 6454Siemens Healthcare Diagnostics · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P820060 | Abbott Afp-Eia Diagnostic Kit for Cancer | Abbott Laboratories | 1983 | 2 |
| −2 | 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 | — |
| 0 (this device) | K090236 | Dimension Vista Afp Flex Reagent Cartridge, Model 6454 | Siemens Healthcare Diagnostics | 2009 | — |
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 |
|---|---|---|---|
| * | K071597 | Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R)…Summary page 1…: Class 11 Classification Panel: Immunology (82) Product Code: LOJ D. Predicate Device: Dimension Vista® AFP Flex® reagent cartridge (K071597) E. Device Description: The Dimension Vista® AFP method is a homogeneous, sandwich chemiluminescent imm… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 4 companies; a new generation was cleared every 10.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K071597.
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. 2009, this device’s year, is highlighted.
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 AFP method is an in vitro diagnostic test for the quantitative measurement of alpha-fetoprotein in human serum and lithium heparinized plasma on the Dimension Vista® System. Measurements of alpha-fetoprotein are used as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090236: Dimension Vista Afp Flex Reagent Cartridge, Model 6454.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090236
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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