Cleared Traditional

CELLTRACKA ANALYZER II

K050145 · Immunicon Corp. · Pathology

Mar 2005

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K050145 is an FDA 510(k) clearance for the CELLTRACKA ANALYZER II, a System, Immunomagnetic, Circulating Cancer Cell, Enumeration (Class II — Special Controls, product code NQI), submitted by Immunicon Corp. (Huntingdon Valley, US). The FDA issued a Cleared decision on March 15, 2005, 50 days after receiving the submission on January 24, 2005. This device falls under the Pathology review panel. Regulated under 21 CFR 866.6020.

Submission Details

510(k) Number	K050145 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 2005
Decision Date	March 15, 2005
Days to Decision	50 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.