Product Classification

• Device: system, immunomagnetic, circulating cancer cell, enumeration
• Regulation Description: Immunomagnetic circulating cancer cell selection and enumeration system.
• 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.
• Regulation Medical Specialty: Immunology
• Review Panel: Pathology
• Product Code: NQI
• Premarket Review: Division of Molecular Genetics and Pathology (DMGP); Division of Molecular Genetics and Pathology (DMGP)
• Submission Type: 510(k)
• Regulation Number: 866.6020
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Guidance Document

• Immunomagnetic Circulating Cancer Cell Selection and Enumeration System - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible