Cleared Traditional

K040898 - CELLSEARCH EPITHELIAL CELL CONTROL KIT (FDA 510(k) Clearance)

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

K040898 · Veridex, LLC · Hematology device
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Jun 2004
Decision
83d
Days
Class 2
Risk

K040898 is an FDA 510(k) clearance for the CELLSEARCH EPITHELIAL CELL CONTROL KIT. Classified as Control Material, Blood Circulating Epithelial Cancer Cell (product code NRS), Class II - Special Controls.

Submitted by Veridex, LLC (Raritan, US). The FDA issued a Cleared decision on June 28, 2004 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - the FDA hematology 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

Submission Details

510(k) Number K040898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2004
Decision Date June 28, 2004
Days to Decision 83 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 113d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NRS Control Material, Blood Circulating Epithelial Cancer Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
Definition The Epithelial Cell Control Kit Contains Two Levels Of Fixed Cells That Are Stained With A Fluorescence Marker And Are Used To Verify Sample Processing And Cell Analysis Of Circulating Tumor Cells. This Device Is Used As An Assay Quality Control To Ensure That Sample Detection And Identification Systems Are Able To Detect Circulating Epithelial Tumor Cells.
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 Hematology devices follow this clearance model.