Celltracks Autoprep System
FDA 510(k) K122821 · Veridex, LLC
510(k) numberK122821
Submission
- Device name
- Celltracks Autoprep System
- Applicant
- Veridex, LLC
Raritan, NJ, US - Received
- September 14, 2012
- Decision date
- December 13, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| K071729 | Cellsearch Circulating Tumor Cell KitNQI · Traditional | Veridex, LLC | 11/20/2007SE |
| 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 |
| 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 |
| K071729 | Cellsearch Circulating Tumor Cell KitNQI · Traditional | 11/20/2007SE |
| 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 Celltracks Autoprep System cleared by the FDA?
Celltracks Autoprep System (K122821) received a 510(k) decision of Substantially Equivalent on December 13, 2012, 90 days after the submission was received.
What is the product code of K122821?
The FDA product code is NQI – System, Immunomagnetic, Circulating Cancer Cell, Enumeration, a Class II (moderate risk) device regulated under 21 CFR 866.6020.