Celltracks Analyzer II
FDA 510(k) K060110 · Immunicon Corp.
510(k) numberK060110
Submission
- Device name
- Celltracks Analyzer II
- Applicant
- Immunicon Corp.
Huntingdon Valley, PA, US - Received
- January 17, 2006
- Decision date
- March 16, 2006
- 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 |
| K071729 | Cellsearch Circulating Tumor Cell KitNQI · Traditional | Veridex, LLC | 11/20/2007SE |
| K062013 | Cellsearch Circulating Tumor Cell KitNQI · Traditional | Veridex, LLC | 12/14/2006SE |
| 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 |
|---|---|---|
| K050145 | Celltracka Analyzer IINQI · Traditional | 03/15/2005SE |
| K040077 | Immunicon Celltracks Autoprep SystemGKH · Traditional | 03/12/2004SE |
| K030263 | Immunicon Celltracks AnalyzerGKZ · Traditional | 11/24/2003SE |
| K030596 | Immunicon Cellsave Preservative TubeJKA · Traditional | 08/08/2003SE |
| K022512 | Cellprep Sample Preparation System, Model 9518GKH · Traditional | 09/30/2002SE |
Questions and answers
When was Celltracks Analyzer II cleared by the FDA?
Celltracks Analyzer II (K060110) received a 510(k) decision of Substantially Equivalent on March 16, 2006, 58 days after the submission was received.
What is the product code of K060110?
The FDA product code is NQI – System, Immunomagnetic, Circulating Cancer Cell, Enumeration, a Class II (moderate risk) device regulated under 21 CFR 866.6020.