Cleared Traditional

CELLSEARCH CIRCULATING TUMOR CELL KIT

K073338 · Veridex, LLC · Pathology

Feb 2008

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K073338 is an FDA 510(k) clearance for the CELLSEARCH CIRCULATING TUMOR CELL KIT, 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 February 26, 2008, 90 days after receiving the submission on November 28, 2007. This device falls under the Pathology review panel. Regulated under 21 CFR 866.6020.

Submission Details

510(k) Number	K073338 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 28, 2007
Decision Date	February 26, 2008
Days to Decision	90 days
Submission Type	Traditional
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.