Product Classification

• Device: cancer-related germline gene mutation detection system
• Definition: The germline gene mutation test system is an in vitro diagnostic nucleic acid amplification and detection system for the identification of genetic mutations in DNA extracted from human clinical specimens.
• Physical State: Test consists of reagents, instrumentation, software and instructions needed to perform the test method.
• Technical Method: In vitro amplification and detection of genomic DNA representing a cancer-related germline gene mutation from a clinical specimen of interest
• Target Area: Human peripheral whole blood or clinical samples
• Review Panel: Pathology
• Product Code: PJG
• Premarket Review: Division of Molecular Genetics and Pathology (DMGP); Division of Molecular Genetics and Pathology (DMGP)
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible