Cleared Traditional

K050245 - CELLSEARCH CIRCULATING TUMOR CELL KIT (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K050245 · Veridex, LLC · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
41d
Days
Class 2
Risk

K050245 is an FDA 510(k) clearance for the CELLSEARCH CIRCULATING TUMOR CELL KIT. Classified as System, Immunomagnetic, Circulating Cancer Cell, Enumeration (product code NQI), Class II - Special Controls.

Submitted by Veridex, LLC (Raritan, US). The FDA issued a Cleared decision on March 15, 2005 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.6020 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Veridex, LLC devices

Submission Details

510(k) Number K050245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2005
Decision Date March 15, 2005
Days to Decision 41 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 77d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.