System, Immunomagnetic, Circulating Cancer Cell, Enumeration
The immunomagnetic circulating cancer cell enumeration system is an immunology in vitro diagnostic device that uses immunomagnetic selection and fluorescent identification to enumerate circulating tumor cells of epithelial origin in whole blood, aiding in the prediction of cancer progression and survival in patients with metastatic cancer. It is classified as FDA Class 2 under regulation 866.6020 in the Immunology specialty (reviewed by Pathology panel), requiring 510(k) clearance. Product code NQI is not eligible for third-party review.
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Basic Information
- Product Code
- NQI
- Device Class
- FDA class 2
- Regulation Number
- 866.6020
- Medical Specialty
- Immunology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K130794 | CELLTRACKS ANALYZER II SYSTEM | Jun 20, 2013 | Substantially Equivalent | Veridex, LLC |
| K122821 | CELLTRACKS AUTOPREP SYSTEM | Dec 13, 2012 | Substantially Equivalent | Veridex, LLC |
| K110406 | CELLTRACKS AUTOPREP SYSTEM | Jan 20, 2012 | Substantially Equivalent | Veridex, LLC |
| K113181 | CELLTRACKS ANALYER II | Dec 12, 2011 | Substantially Equivalent | Veridex, LLC |
| K103502 | CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 | Dec 21, 2010 | Substantially Equivalent | Veridex, LLC |
| K073338 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Feb 26, 2008 | Substantially Equivalent | Veridex, LLC |
| K071729 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Nov 20, 2007 | Substantially Equivalent | Veridex, LLC |
| K062013 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Dec 14, 2006 | Substantially Equivalent | Veridex, LLC |
| K060110 | CELLTRACKS ANALYZER II | Mar 16, 2006 | Substantially Equivalent | Immunicon Corp. |
| K052191 | MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT | Oct 27, 2005 | Substantially Equivalent | Veridex, LLC |
| K050245 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Mar 15, 2005 | Substantially Equivalent | Veridex, LLC |
| K050145 | CELLTRACKA ANALYZER II | Mar 15, 2005 | Substantially Equivalent | Immunicon Corp. |
| DEN040001 | CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM | Jan 21, 2004 | Unknown | Advanced Diagnostic Systems |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.