Cellsearch Circulating Tumor Cell Kit

• • Terminated Z-0819-2010 FDA Unclassified (pre-2012) ·initiated 12 Aug 2009

  Veridex has received 4 complaints regarding reagent bottles having been incorrectly placed or duplicate bottles places within the reagent tray of CellSearch Circulating Tumor Cell Kit. Delayed detection of disease relapse or progression may occur due to false low CTC results.

510(k) Number

K073338 ↗

FDA Product Code

NQI

Device Class

Class II

Regulation

21 CFR Part 866.6020

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Celltracks Autoprep System MODEL:9541

  Class I

  FDA 510(k) K100684 Active Cleared 26 Aug 2010

• Cellsearch Circulating Tumor Cell Kit

  Class II

  FDA 510(k) K062013 Active Cleared 14 Dec 2006

• Cellsearch Epithelial Cell Control Kit

  Class II

  FDA 510(k) K040898 Active Cleared 28 Jun 2004

• Celltracks Autoprep System

  Class II

  FDA 510(k) K110406 Active Cleared 20 Jan 2012

• Celltracks Analyzer II System

  Class II

  FDA 510(k) K130794 Active Cleared 20 Jun 2013

• Cellsearch Circulating Tumor Cell Kit Model 7900001 Open recall

  Class II

  FDA 510(k) K103502 Active Cleared 21 Dec 2010

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