Cleared Special

CELLTRACKS AUTOPREP SYSTEM

K110406 · Veridex, LLC · Pathology

Jan 2012

Decision

340d

Days

Class 2

Risk

About This 510(k) Submission

K110406 is an FDA 510(k) clearance for the CELLTRACKS AUTOPREP SYSTEM, 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 January 20, 2012, 340 days after receiving the submission on February 14, 2011. This device falls under the Pathology review panel. Regulated under 21 CFR 866.6020.

Submission Details

510(k) Number	K110406 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 14, 2011
Decision Date	January 20, 2012
Days to Decision	340 days
Submission Type	Special
Review Panel	Pathology (PA)
Summary	Statement

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.