# K060264: Dimension Iron Flex Reagent Cartridge (Iron-DF85)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 8, 2006 after 35 days
- Product code: JIY (Photometric Method, Iron (Non-Heme))
- Device class: 1
- Regulation: 21 CFR 862.1410
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944093 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944093: Dimension (R) XL Clinical Chemistry System, E.I. Dupont DE Nemours & Co., Inc. (1994) Summary page 2.

## Most influential descendants
- K061793: Dimension Vista Iron Flex Reagent Cartridge and Calibrator (2006), 0 descendants of its own

## Recalls of this device
- Aug 25, 2016 · Class III · Z-0401-2017: Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU).
- Aug 25, 2016 · Class III · Z-0402-2017: Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU).

## Indications for use
The IRON method for the Dimension® clinical chemistry 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.

Source page: https://510kreport.com/device/K060264
Methodology: https://510kreport.com/methodology