Cleared Traditional

K052191 - MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT

K052191 is an FDA 510(k) clearance for MODIFICATION TO CELLSEARCH CIRCULATING ..., manufactured by Veridex, LLC. The device is a Class 2 Pathology device with product code NQI cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K052191 · Veridex, LLC · Pathology device
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Oct 2005
Decision
77d
Days
Class 2
Risk

K052191 is an FDA 510(k) clearance for the MODIFICATION TO 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 October 27, 2005 after a review of 77 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

FDA 510(k) Submission Details - K052191

510(k) Number K052191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2005
Decision Date October 27, 2005
Days to Decision 77 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 77d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NQI Device Classification - Class 2, Special Controls

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.

Regulatory Peers - NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration

All 10
Devices cleared under the same product code (NQI) and FDA review panel - the closest regulatory comparables to K052191.
CELLSEARCH CIRCULATING TUMOR CELL KIT
K071729 · Veridex, LLC · Nov 2007
CELLSEARCH CIRCULATING TUMOR CELL KIT
K062013 · Veridex, LLC · Dec 2006
CELLTRACKS ANALYZER II
K060110 · Immunicon Corp. · Mar 2006
CELLTRACKA ANALYZER II
K050145 · Immunicon Corp. · Mar 2005
CELLSEARCH CIRCULATING TUMOR CELL KIT
K050245 · Veridex, LLC · Mar 2005