• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
New Search Back to Search Results
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 CodePJG
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible