Product code NQI— Immunology
CELLSEARCH CIRCULATING TUMOR CELL KIT
- Classification name
- System, Immunomagnetic, Circulating Cancer Cell, Enumeration
- Device class
- Class 2
- Regulation
- 21 CFR 866.6020
- Advisory panel
- Immunology
- Total cleared
- 13
- First cleared
- Most recent
FDA classification 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.”
Market context for product code NQI
FDA has cleared devices under product code NQI between 2004 and 2013, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2013
- 2012
- 2011
- 2010
- 2008
- 2007
- 2006
- 2005
- 2004
Top applicants under product code NQI
Recent clearances under product code NQI
- K130794 — CELLTRACKS ANALYZER II SYSTEM
- K122821 — CELLTRACKS AUTOPREP SYSTEM
- K110406 — CELLTRACKS AUTOPREP SYSTEM
- K113181 — CELLTRACKS ANALYER II
- K103502 — CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001
- K073338 — CELLSEARCH CIRCULATING TUMOR CELL KIT
- K071729 — CELLSEARCH CIRCULATING TUMOR CELL KIT
- K062013 — CELLSEARCH CIRCULATING TUMOR CELL KIT
- K060110 — CELLTRACKS ANALYZER II
- K052191 — MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT
- K050145 — CELLTRACKA ANALYZER II
- K050245 — CELLSEARCH CIRCULATING TUMOR CELL KIT
- DEN040001 — CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.