NQI · System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Immunology · 21 CFR 866.6020 · Class 2
Overview
| Product Code | NQI |
|---|---|
| Device Name | System, Immunomagnetic, Circulating Cancer Cell, Enumeration |
| Regulation | 21 CFR 866.6020 |
| Device Class | Class 2 |
| Review Panel | Immunology |
Identification
An immunomagnetic circulating cancer cell selection and enumeration system is a device that consists of biological probes, fluorochromes, and other reagents; preservation and preparation devices; and a semiautomated analytical instrument to select and count circulating cancer cells in a prepared sample of whole blood. This device is intended for adjunctive use in monitoring or predicting cancer disease progression, response to therapy, and for the detection of recurrent disease.
Classification Rationale
Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System.” See § 866.1(e) for availability of this guidance document.
Special Controls
The device is classified as Class II under regulation 21 CFR 866.6020 with special controls. The special control guidance document "Immunomagnetic Circulating Cancer Cell Selection and Enumeration System" is available at https://www.fda.gov/cdrh/oivd/guidance/1531.pdf
*Classification.* Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System.” See § 866.1(e) for availability of this guidance document.
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K130794 | CELLTRACKS ANALYZER II SYSTEM | Veridex, LLC | Jun 20, 2013 | SESE |
| K122821 | CELLTRACKS AUTOPREP SYSTEM | Veridex, LLC | Dec 13, 2012 | SESE |
| K110406 | CELLTRACKS AUTOPREP SYSTEM | Veridex, LLC | Jan 20, 2012 | SESE |
| K113181 | CELLTRACKS ANALYER II | Veridex, LLC | Dec 12, 2011 | SESE |
| K103502 | CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 | Veridex, LLC | Dec 21, 2010 | SESE |
| K073338 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | Feb 26, 2008 | SESE |
| K071729 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | Nov 20, 2007 | SESE |
| K062013 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | Dec 14, 2006 | SESE |
| K060110 | CELLTRACKS ANALYZER II | Immunicon Corp. | Mar 16, 2006 | SESE |
| K052191 | MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | Oct 27, 2005 | SESE |
| K050245 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | Mar 15, 2005 | SESE |
| K050145 | CELLTRACKA ANALYZER II | Immunicon Corp. | Mar 15, 2005 | SESE |
| DEN040001 | CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM | Advanced Diagnostic Systems | Jan 21, 2004 | DENG |
Top Applicants
- Veridex, LLC — 10 clearances
- Immunicon Corp. — 2 clearances
- Advanced Diagnostic Systems — 1 clearance
