Cleared Special

CELLTRACKS ANALYER II

K113181 · Veridex, LLC · Pathology

Dec 2011

Decision

45d

Days

Class 2

Risk

About This 510(k) Submission

K113181 is an FDA 510(k) clearance for the CELLTRACKS ANALYER II, 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 12, 2011, 45 days after receiving the submission on October 28, 2011. This device falls under the Pathology review panel. Regulated under 21 CFR 866.6020.

Submission Details

510(k) Number	K113181 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 28, 2011
Decision Date	December 12, 2011
Days to Decision	45 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.