Not Cleared Post-NSE

CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT (DEN040001) - FDA 510(k) Clearance

Also marketed or referenced as:
CELLSPOTTER SYSTEM

Class II Pathology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN040001 · Advanced Diagnostic Systems · Pathology device
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Jan 2004
Decision
19d
Days
Class 2
Risk

DEN040001 is an FDA 510(k) submission (not cleared) for the CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT. Classified as System, Immunomagnetic, Circulating Cancer Cell, Enumeration (product code NQI), Class II - Special Controls.

Submitted by Advanced Diagnostic Systems (Raritan, US). The FDA issued a Not Cleared (DENG) decision on January 21, 2004 after a review of 19 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Pathology review framework.

View all Advanced Diagnostic Systems devices

Submission Details

510(k) Number DEN040001 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 02, 2004
Decision Date January 21, 2004
Days to Decision 19 days
Submission Type Post-NSE
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 77d · This submission: 19d
Pathway characteristics

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.