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510(k) DEN040001

CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM by Advanced Diagnostic Systems — Product Code NQI

DEN040001 is an FDA 510(k) premarket notification submitted by Advanced Diagnostic Systems for the device "CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM". The FDA issued a decision of De Novo Granted on January 21, 2004. The device falls under product code NQI (System, Immunomagnetic, Circulating Cancer Cell, Enumeration), a Class II device regulated under 21 CFR 866.6020.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
January 21, 2004
Date Received
January 2, 2004
Clearance Type
Post-NSE
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 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)
  • K052191 — MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT (October 27, 2005)

FDA data resources