Cleared Traditional

CELLTRACKS ANALYZER II SYSTEM

K130794 · Veridex, LLC · Pathology

Jun 2013

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K130794 is an FDA 510(k) clearance for the CELLTRACKS ANALYZER II 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 June 20, 2013, 90 days after receiving the submission on March 22, 2013. This device falls under the Pathology review panel. Regulated under 21 CFR 866.6020.

Submission Details

510(k) Number	K130794 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2013
Decision Date	June 20, 2013
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.