K052191 is an FDA 510(k) clearance for the MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT. This device is classified as a System, Immunomagnetic, Circulating Cancer Cell, Enumeration (Class II - Special Controls, product code NQI).
Submitted by Veridex, LLC (Raritan, US). The FDA issued a Cleared decision on October 27, 2005, 77 days after receiving the submission on August 11, 2005.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 866.6020. 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) Number | K052191 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2005 |
| Decision Date | October 27, 2005 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Statement |
| Product Code | NQI — System, Immunomagnetic, Circulating Cancer Cell, Enumeration |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6020 |
| 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. |