510(k) · Cleared
ClearedDimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator, Model KC600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Cleared on Jun 4, 2008 as substantially equivalent to P820060 (Abbott Laboratories, 1983) and 1 other predicate after a 358-day review. Its family tree reaches back 2 generations to 1983. 2 later devices descend from it.
- Decided
- Jun 4, 2008
- Review
- 358 days
- Class
- Class II
- Product code
- LOJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to P820060 (1983). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backP820060 Abbott Afp-Eia Diagnostic Kit for CancerAbbott Laboratories · 1983 · Recalled
- 1 generation backK981354 Access Afp Reagents on the Access Immunoassay Analyzer Model Number…Beckman Instruments, Inc. · 1998 · Recalled
- This deviceK071597 Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454…Dade Behring, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK100321 Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions…Siemens Healthcare Diagnostics · 2011
- Descendant · cites it directly · 0 of its ownK090236 Dimension Vista Afp Flex Reagent Cartridge, Model 6454Siemens Healthcare Diagnostics · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P820060 | Abbott Afp-Eia Diagnostic Kit for Cancer | Abbott Laboratories | 1983 | 2 |
| −1 | K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211 | Beckman Instruments, Inc. | 1998 | 1 |
| 0 (this device) | K071597 | Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension… | Dade Behring, Inc. | 2008 | — |
| +1 | K100321 | Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6… | Siemens Healthcare Diagnostics | 2011 | — |
| +1 | 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 |
|---|---|---|
| 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? (2)
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…II Dimension Vista® LOCI 5 calibrator/ Class II 3. Identification of the Predicate Device * Abbott AxSYM® AFP Method (P820060/SO19) * Beckman Access AFP Calibrators on the Access® Immunoassay System (K981354).… | 1983 |
| * | K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211Summary page 1…* Abbott AxSYM® AFP Method (P820060/SO19) * Beckman Access AFP Calibrators on the Access® Immunoassay System (K981354). FDA Guidance Document(s): · "Bundling Multiple Devices or Multiple Indications in a Single Submission… | 1998 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 3 companies; a new generation was cleared every 14.9 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K100321 (Siemens Healthcare Diagnostics, 2011) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate P820060.
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. 2008, 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 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.
For the calibration of the Alpha-Fetoprotein (AFP) method on the Dimension Vista® System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071597 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071597: Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator, Model KC600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071597
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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