# K061793: Dimension Vista Iron Flex Reagent Cartridge and Calibrator

- Pathway: 510(k) (Special)
- Applicant: Dade Behring, Inc.
- Decided: Aug 7, 2006 after 42 days
- Product code: JIY (Photometric Method, Iron (Non-Heme))
- Device class: 1
- Regulation: 21 CFR 862.1410
- 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 K944093 (1994). 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)
- K060264: Dimension Iron Flex Reagent Cartridge (Iron-DF85), Dade Behring, Inc. (2006) Summary page 2.
- K060266: Dimension Iron Calibrator, Dade Behring, Inc. (2006) Summary page 5.

## Recalls of this device
- Oct 8, 2012 · Class II · Z-0452-2013: Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON Flex(R) reagent cartridges when tests are processed from a well set contaminated with iron from enviro

## Indications for use
The iron method for the Dimension Vista TM system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma. Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism. The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension Vista System.

Source page: https://510kreport.com/device/K061793
Methodology: https://510kreport.com/methodology