# K071597: Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator, Model KC600

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jun 4, 2008 after 358 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: 2 generations back to P820060 (1983). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P820060: Abbott Afp-Eia Diagnostic Kit for Cancer, Abbott Laboratories (1983) Summary page 1.
- K981354: Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211, Beckman Instruments, Inc. (1998) Summary page 1.

## Most influential descendants
- K100321: Dimension Vista Loci CA 125 Flex Reagent Cartridge,and Dimensions Vista Loci 6 Cal, Model#'S K6455, and KC604 (2011), 0 descendants of its own
- K090236: Dimension Vista Afp Flex Reagent Cartridge, Model 6454 (2009), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K071597
Methodology: https://510kreport.com/methodology