Modification to Cellsearch Circulating Tumor Cell Kit

• • Terminated Z-1102-2007 FDA Unclassified (pre-2012) ·initiated 17 Apr 2007

  An increased incidence of aggregates was observed in Lot 0036 and 0036A. The presence of aggregates will cause customers to invalidate patient results.

510(k) Number

K052191 ↗

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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