Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with Cdm 4.0

• • Terminated Z-1342-2011 FDA Unclassified (pre-2012) ·initiated 24 Mar 2010

  The firm received customer complaints associated with the Update Kit CD-ROM not being able to generate a valid calibration after being uploaded, resulting in patient results not being generated.

• • Terminated Z-1898-2011 FDA Unclassified (pre-2012) ·initiated 8 Dec 2009

  Wrong lot number was found on the Hemoglobin Cartridge Insert . The insert did not match the lot number to the device cartridge or the device cartridge label or on the Update Kit CD.

• • Terminated Z-0867-2010 FDA Unclassified (pre-2012) ·initiated 12 Oct 2009

  Product update kit CD rom will not upload. As a result, the device cannot be run.

• • Terminated Z-1041-2009 FDA Unclassified (pre-2012) ·initiated 17 Oct 2008

  Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results.

510(k) Number

K063400 ↗

FDA Product Code

LCP

Device Class

Class II

Regulation

21 CFR Part 864.7470

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• Access Ck-Mb Reagents

  Class II

  FDA 510(k) K945083 Active Cleared 21 Nov 1994

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