Cleared Traditional

K130794 - CELLTRACKS ANALYZER II SYSTEM (FDA 510(k) Clearance)

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

K130794 · Veridex, LLC · Pathology device
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Jun 2013
Decision
90d
Days
Class 2
Risk

K130794 is an FDA 510(k) clearance for the CELLTRACKS ANALYZER II SYSTEM. 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 June 20, 2013 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K130794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2013
Decision Date June 20, 2013
Days to Decision 90 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
13d slower than avg
Panel avg: 77d · This submission: 90d
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.