Cleared Special

CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001

K103502 · Veridex, LLC · Pathology
Dec 2010
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K103502 is an FDA 510(k) clearance for the CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001, 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 December 21, 2010, 22 days after receiving the submission on November 29, 2010. This device falls under the Pathology review panel. Regulated under 21 CFR 866.6020.

Submission Details

510(k) Number K103502 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2010
Decision Date December 21, 2010
Days to Decision 22 days
Submission Type Special
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

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.