Total Iron Binding Capacity (Ibct) Flex Reagent Cartridge

• • Terminated Z-0933-2013 FDA Class III ·initiated 20 Dec 2012

  The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid. Siemens is conducting a voluntary corrective action for Dimension Total Iron Binding Capacity (IBCT) to modify the analytical sensitivity claim to 36 ug/dL (6.44 umol/L).

• • Terminated Z-2385-2010 FDA Unclassified (pre-2012) ·initiated 16 Dec 2009

  Test produces falsely elevated IBCT results and Abnormal Reaction test report messages on heparinized plasma samples.

510(k) Number

K994115 ↗

FDA Product Code

JMO

Device Class

Class I

Regulation

21 CFR Part 862.1415

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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