Cellsearch Circulating Tumor Cell Kit
FDA 510(k) K071729 · Veridex, LLC
510(k) numberK071729
Submission
- Device name
- Cellsearch Circulating Tumor Cell Kit
- Applicant
- Veridex, LLC
Raritan, NJ, US - Received
- June 25, 2007
- Decision date
- November 20, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQI – System, Immunomagnetic, Circulating Cancer Cell, Enumeration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6020
- Specialty
- Immunology
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 510(k)s with product code NQI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K130794 | Celltracks Analyzer II SystemNQI · Traditional | Veridex, LLC | 06/20/2013SE |
| K122821 | Celltracks Autoprep SystemNQI · Special | Veridex, LLC | 12/13/2012SE |
| K110406 | Celltracks Autoprep SystemNQI · Special | Veridex, LLC | 01/20/2012SE |
| K113181 | Celltracks Analyer IINQI · Special | Veridex, LLC | 12/12/2011SE |
| K103502 | Cellsearch Circulating Tumor Cell Kit Model 7900001NQI · Special | Veridex, LLC | 12/21/2010SE |
| K073338 | Cellsearch Circulating Tumor Cell KitNQI · Traditional | Veridex, LLC | 02/26/2008SE |
| K062013 | Cellsearch Circulating Tumor Cell KitNQI · Traditional | Veridex, LLC | 12/14/2006SE |
| K060110 | Celltracks Analyzer IINQI · Traditional | Immunicon Corp. | 03/16/2006SE |
| K052191 | Modification to Cellsearch Circulating Tumor Cell KitNQI · Traditional | Veridex, LLC | 10/27/2005SE |
| K050245 | Cellsearch Circulating Tumor Cell KitNQI · Traditional | Veridex, LLC | 03/15/2005SE |
More from Veridex, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K130794 | Celltracks Analyzer II SystemNQI · Traditional | 06/20/2013SE |
| K122821 | Celltracks Autoprep SystemNQI · Special | 12/13/2012SE |
| K110406 | Celltracks Autoprep SystemNQI · Special | 01/20/2012SE |
| K113181 | Celltracks Analyer IINQI · Special | 12/12/2011SE |
| K103502 | Cellsearch Circulating Tumor Cell Kit Model 7900001NQI · Special | 12/21/2010SE |
| K100684 | Celltracks Autoprep System MODEL:9541GKH · Traditional | 08/26/2010SE |
| K073338 | Cellsearch Circulating Tumor Cell KitNQI · Traditional | 02/26/2008SE |
| K062013 | Cellsearch Circulating Tumor Cell KitNQI · Traditional | 12/14/2006SE |
| K052191 | Modification to Cellsearch Circulating Tumor Cell KitNQI · Traditional | 10/27/2005SE |
| K050245 | Cellsearch Circulating Tumor Cell KitNQI · Traditional | 03/15/2005SE |
Questions and answers
When was Cellsearch Circulating Tumor Cell Kit cleared by the FDA?
Cellsearch Circulating Tumor Cell Kit (K071729) received a 510(k) decision of Substantially Equivalent on November 20, 2007, 148 days after the submission was received.
What is the product code of K071729?
The FDA product code is NQI – System, Immunomagnetic, Circulating Cancer Cell, Enumeration, a Class II (moderate risk) device regulated under 21 CFR 866.6020.