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CellSearch Epithelial Cell Enrichment Kit; CellSpotter System

by Advanced Diagnostic Systems

De Novo DEN040001

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Post-NSE NumberDEN040001 Date21 Jan 2004DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Specification

De Novo

De Novo Number
FDA Product Code
NQI
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 866.6020
Advisory Committee
Immunology
FDA Decision
DENG De Novo granted

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CellSearch Epithelial Cell Enrichment Kit; CellSpotter System is an immunomagnetic system for the enumeration of circulating cancer cells. This device is designed to enrich and detect epithelial cells from blood samples, providing a method for cancer cell analysis.

The system is supplied as a kit and is intended for laboratory use. It is a Class II medical device with FDA 510(k) clearance under product code NQI. The device is manufactured by Advanced Diagnostic Systems and is regulated under 866.6020.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of the CellSearch Epithelial Cell Enrichment Kit?

    The CellSearch Epithelial Cell Enrichment Kit is an immunomagnetic system designed to enrich and detect epithelial cells from blood samples, providing a method for cancer cell analysis in laboratory settings.

  • How is the CellSearch Epithelial Cell Enrichment Kit supplied?

    The system is supplied as a complete kit intended for laboratory use. It includes all necessary components for the enrichment and enumeration of circulating epithelial cells from blood samples.

  • What is the regulatory classification of the CellSearch system?

    The CellSearch Epithelial Cell Enrichment Kit is a Class II medical device with FDA 510(k) clearance under product code NQI, regulated under 866.6020, and manufactured by Advanced Diagnostic Systems.

  • What types of cells can be detected using the CellSearch system?

    The CellSearch system is specifically designed to enrich and detect epithelial cells from blood samples, which is particularly useful for analyzing circulating cancer cells in patients with various types of carcinomas.