# K060266: Dimension Iron Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 9, 2006 after 36 days
- Product code: JIS (Calibrator, Primary)
- 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: 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
- Dec 20, 2012 · Class III · Z-0745-2013: Siemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable calibration slope (m) values (0.97 - 1.03) when using IRON calibrator lots 2DN060 and 2FN063. Lots 2GN

## Indications for use
The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension® clinical chemistry system.

Source page: https://510kreport.com/device/K060266
Methodology: https://510kreport.com/methodology