Cleared Traditional

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

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

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

Submitted by Veridex, LLC (Raritan, US). The FDA issued a Cleared decision on June 28, 2004, 83 days after receiving the submission on April 6, 2004.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625. 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..

Submission Details

510(k) Number K040898 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code NRS — Control Material, Blood Circulating Epithelial Cancer Cell
Device Class Class II — 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.