Cleared Traditional

K060110 - CELLTRACKS ANALYZER II (FDA 510(k) Clearance)

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

K060110 · Immunicon Corp. · Pathology device
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Optimized for regulatory review, auditing and printing
Mar 2006
Decision
58d
Days
Class 2
Risk

K060110 is an FDA 510(k) clearance for the CELLTRACKS ANALYZER II. Classified as System, Immunomagnetic, Circulating Cancer Cell, Enumeration (product code NQI), Class II - Special Controls.

Submitted by Immunicon Corp. (Huntingdon Valley, US). The FDA issued a Cleared decision on March 16, 2006 after a review of 58 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 Immunicon Corp. devices

Submission Details

510(k) Number K060110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2006
Decision Date March 16, 2006
Days to Decision 58 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
19d faster than avg
Panel avg: 77d · This submission: 58d
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.