FDA Product Code PTA: Genetic Variant Detection And Health Risk Assessment System
A Qualitative In Vitro Molecular Test That Detects Variants In Genomic Dna Isolated From Human Specimens. This Assessment System Provides Users With A Genetic Health Risk Assessment Of Developing A Disease And Is Intended To Inform Users Of Lifestyle Choices And/or Encourage Conversations With A Healthcare Professional. This Assessment System Is For Over-the-counter Use. This Device Does Not Determine The Persons Overall Risk Of Developing A Disease.
Leading manufacturers include Targeted Genomics, LLC and Progenika Biopharma S.A., A Grifols Company.
FDA 510(k) Cleared Genetic Variant Detection And Health Risk Assessment System Devices (Product Code PTA)
About Product Code PTA - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code PTA since 2017, with 4 receiving FDA clearance (average review time: 297 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under PTA have taken an average of 230 days to reach a decision - down from 314 days historically, suggesting improved FDA processing for this classification.
PTA devices are reviewed by the Immunology panel. Browse all Immunology devices →