NQI · Class II · 21 CFR 866.6020

FDA Product Code NQI: System, Immunomagnetic, Circulating Cancer Cell, Enumeration

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.

Leading manufacturers include Veridex, LLC, Immunicon Corp. and Advanced Diagnostic Systems.

13
Total
12
Cleared
94d
Avg days
2004
Since

FDA 510(k) Cleared System, Immunomagnetic, Circulating Cancer Cell, Enumeration Devices (Product Code NQI)

13 devices
1–13 of 13
Cleared Jun 20, 2013
CELLTRACKS ANALYZER II SYSTEM
K130794
Veridex, LLC
Pathology · 90d
Cleared Dec 13, 2012
CELLTRACKS AUTOPREP SYSTEM
K122821
Veridex, LLC
Pathology · 90d
Cleared Jan 20, 2012
CELLTRACKS AUTOPREP SYSTEM
K110406
Veridex, LLC
Pathology · 340d
Cleared Dec 12, 2011
CELLTRACKS ANALYER II
K113181
Veridex, LLC
Pathology · 45d
Cleared Dec 21, 2010
CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001
K103502
Veridex, LLC
Pathology · 22d
Cleared Feb 26, 2008
CELLSEARCH CIRCULATING TUMOR CELL KIT
K073338
Veridex, LLC
Pathology · 90d
Cleared Nov 20, 2007
CELLSEARCH CIRCULATING TUMOR CELL KIT
K071729
Veridex, LLC
Pathology · 148d
Cleared Dec 14, 2006
CELLSEARCH CIRCULATING TUMOR CELL KIT
K062013
Veridex, LLC
Pathology · 150d
Cleared Mar 16, 2006
CELLTRACKS ANALYZER II
K060110
Immunicon Corp.
Pathology · 58d
Cleared Oct 27, 2005
MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT
K052191
Veridex, LLC
Pathology · 77d
Cleared Mar 15, 2005
CELLTRACKA ANALYZER II
K050145
Immunicon Corp.
Pathology · 50d
Cleared Mar 15, 2005
CELLSEARCH CIRCULATING TUMOR CELL KIT
K050245
Veridex, LLC
Pathology · 41d
Not Cleared Jan 21, 2004
CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT
DEN040001
Advanced Diagnostic Systems
Pathology · 19d

About Product Code NQI - Regulatory Context