510(k) K052191

MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT by Veridex, LLC — Product Code NQI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 27, 2005
Date Received: August 11, 2005
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Device Class: Class II
Regulation Number: 866.6020
Review Panel: PA
Submission Type

In vitro diagnostic device to aid in the enumeration of immunomagnetically selected and fluorescently identified circulating tumor cells of epithelial origin in whole blood for prediction of cancer progression and survival.

Other clearances by Veridex, LLC

K130794 — CELLTRACKS ANALYZER II SYSTEM (June 20, 2013)
K122821 — CELLTRACKS AUTOPREP SYSTEM (December 13, 2012)
K110406 — CELLTRACKS AUTOPREP SYSTEM (January 20, 2012)
K113181 — CELLTRACKS ANALYER II (December 12, 2011)
K103502 — CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 (December 21, 2010)
K100684 — CELLTRACKS AUTOPREP SYSTEM MODEL:9541 (August 26, 2010)
K073338 — CELLSEARCH CIRCULATING TUMOR CELL KIT (February 26, 2008)
K071729 — CELLSEARCH CIRCULATING TUMOR CELL KIT (November 20, 2007)
K062013 — CELLSEARCH CIRCULATING TUMOR CELL KIT (December 14, 2006)
K050245 — CELLSEARCH CIRCULATING TUMOR CELL KIT (March 15, 2005)

Other clearances for product code NQI

K130794 — CELLTRACKS ANALYZER II SYSTEM (June 20, 2013)
K122821 — CELLTRACKS AUTOPREP SYSTEM (December 13, 2012)
K110406 — CELLTRACKS AUTOPREP SYSTEM (January 20, 2012)
K113181 — CELLTRACKS ANALYER II (December 12, 2011)
K103502 — CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 (December 21, 2010)
K073338 — CELLSEARCH CIRCULATING TUMOR CELL KIT (February 26, 2008)
K071729 — CELLSEARCH CIRCULATING TUMOR CELL KIT (November 20, 2007)
K062013 — CELLSEARCH CIRCULATING TUMOR CELL KIT (December 14, 2006)
K060110 — CELLTRACKS ANALYZER II (March 16, 2006)
K050245 — CELLSEARCH CIRCULATING TUMOR CELL KIT (March 15, 2005)