NQI
13 FDA 510(k) clearances · Product code
77 daysmedian time to decision
150 days90th percentile
13clearances measured
FDA profile
- Official device name
- System, Immunomagnetic, Circulating Cancer Cell, Enumeration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6020
- Medical specialty
- Immunology
- FDA 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.
- Adverse events (MAUDE)
- 2008: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CELLTRACKS ANALYZER II SYSTEM (K130794) | Veridex, LLC | 2013-06-20 |
| CELLTRACKS AUTOPREP SYSTEM (K122821) | Veridex, LLC | 2012-12-13 |
| CELLTRACKS AUTOPREP SYSTEM (K110406) | Veridex, LLC | 2012-01-20 |
| CELLTRACKS ANALYER II (K113181) | Veridex, LLC | 2011-12-12 |
| CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 (K103502) | Veridex, LLC | 2010-12-21 |
| CELLSEARCH CIRCULATING TUMOR CELL KIT (K073338) | Veridex, LLC | 2008-02-26 |
| CELLSEARCH CIRCULATING TUMOR CELL KIT (K071729) | Veridex, LLC | 2007-11-20 |
| CELLSEARCH CIRCULATING TUMOR CELL KIT (K062013) | Veridex, LLC | 2006-12-14 |
| CELLTRACKS ANALYZER II (K060110) | Immunicon Corp. | 2006-03-16 |
| MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT (K052191) | Veridex, LLC | 2005-10-27 |
| CELLTRACKA ANALYZER II (K050145) | Immunicon Corp. | 2005-03-15 |
| CELLSEARCH CIRCULATING TUMOR CELL KIT (K050245) | Veridex, LLC | 2005-03-15 |
| CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM (DEN040001) | Advanced Diagnostic Systems | 2004-01-21 |
Track NQI automatically
Every clearance here is in the API, with alerts when new ones post.