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NQI — System, Immunomagnetic, Circulating Cancer Cell, Enumeration Class II

FDA Device Classification

Classification Details

Product Code
NQI
Device Class
Class II
Regulation Number
866.6020
Submission Type
Review Panel
PA
Medical Specialty
Immunology
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K130794veridexCELLTRACKS ANALYZER II SYSTEMJune 20, 2013
K122821veridexCELLTRACKS AUTOPREP SYSTEMDecember 13, 2012
K110406veridexCELLTRACKS AUTOPREP SYSTEMJanuary 20, 2012
K113181veridexCELLTRACKS ANALYER IIDecember 12, 2011
K103502veridexCELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001December 21, 2010
K073338veridexCELLSEARCH CIRCULATING TUMOR CELL KITFebruary 26, 2008
K071729veridexCELLSEARCH CIRCULATING TUMOR CELL KITNovember 20, 2007
K062013veridexCELLSEARCH CIRCULATING TUMOR CELL KITDecember 14, 2006
K060110immuniconCELLTRACKS ANALYZER IIMarch 16, 2006
K052191veridexMODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KITOctober 27, 2005
K050245veridexCELLSEARCH CIRCULATING TUMOR CELL KITMarch 15, 2005
K050145immuniconCELLTRACKA ANALYZER IIMarch 15, 2005
DEN040001advanced diagnostic systemsCELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEMJanuary 21, 2004