# K090236: Dimension Vista Afp Flex Reagent Cartridge, Model 6454

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Apr 27, 2009 after 84 days
- Product code: LOJ (Kit, Test,Alpha-Fetoprotein For Testicular Cancer)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P820060 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071597: Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator, Model KC600, Dade Behring, Inc. (2008) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K090236
Methodology: https://510kreport.com/methodology