Product Classification

• Device: system, blood collection, rna stabilization, rna purification, rt-pcr molecular diagnostic test
• Regulation Description: RNA Preanalytical Systems.
• Definition: System for collection, storage, and transport of whole blood and stabilization of intracellular rna with subsequent isolation and purification of host rna for rt-pcr used in molecular diagnostic testing
• Regulation Medical Specialty: Immunology
• Review Panel: Pathology
• Product Code: NTW
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Molecular Genetics and Pathology (DMGP)
• Submission Type: 510(k)
• Regulation Number: 866.4070
• 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

• Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization and Purification Systems for RT-PCR used in Molecular Diagnostic Testing)

Third Party Review

Not Third Party Eligible