Cleared Special

CELLTRACKS AUTOPREP SYSTEM

K122821 · Veridex, LLC · Pathology

Dec 2012

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K122821 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 December 13, 2012, 90 days after receiving the submission on September 14, 2012. This device falls under the Pathology review panel. Regulated under 21 CFR 866.6020.

Submission Details

510(k) Number	K122821 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 14, 2012
Decision Date	December 13, 2012
Days to Decision	90 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.