# K070552: Dimension Vista Ferritin Flex Reagent Cartridge (Ferr)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Apr 30, 2007 after 62 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K963493 (1996). 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)
- K963498: Ferr Flex Reagent Cartridge, Dade Chemistry Systems, Inc. (1997) Summary page 1.
- K983548: Ferritin Calibrator, Dade Behring, Inc. (1998) Summary page 1.

## Recalls of this device
- Mar 21, 2017 · Class II · Z-2609-2017: The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FE

## Indications for use
The FERR method is an in vitro diagnostic device for the quantitative measurement of ferritin in human serum and plasma (lithium or sodium heparin, and EDTA) on the Dimension Vista® System. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia. The Dimension Vista™ LOCI 4 Calibrator is an in vitro diagnostic device intended to be used to calibrate the ferritin (FERR) assay on the Dimension Vista™ system.

Source page: https://510kreport.com/device/K070552
Methodology: https://510kreport.com/methodology