Cleared Special

K122821 - CELLTRACKS AUTOPREP SYSTEM (FDA 510(k) Clearance)

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

K122821 · Veridex, LLC · Pathology device
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Dec 2012
Decision
90d
Days
Class 2
Risk

K122821 is an FDA 510(k) clearance for the CELLTRACKS AUTOPREP 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 December 13, 2012 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K122821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2012
Decision Date December 13, 2012
Days to Decision 90 days
Submission Type Special
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
Modification to existing cleared device.

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.