PTA · Class II · 21 CFR 866.5950

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 Person’s Overall Risk Of Developing A Disease.

Leading manufacturers include 23AndMe, Inc., Helix Opco, LLC and Ancestry Genomics, Inc..

5
Total
4
Cleared
297d
Avg days
2017
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 230d recently vs 314d historically

FDA 510(k) Cleared Genetic Variant Detection And Health Risk Assessment System Devices (Product Code PTA)

5 devices
1–5 of 5
Cleared Jan 07, 2025
GlutenID Celiac Genetic Health Risk Test
K241456
Targeted Genomics, LLC
Immunology · 230d
Cleared Oct 27, 2022
AlphaID™ At Home Genetic Health Risk Service
K221420
Progenika Biopharma S.A., A Grifols Company
Immunology · 164d
Cleared Dec 23, 2020
Helix Genetic Health Risk App for late-onset Alzheimer’s disease
K192073
Helix Opco, LLC
Immunology · 509d
Cleared Aug 13, 2020
AncestryDNA Factor V Leiden Genetic Health Risk Test
K192944
Ancestry Genomics, Inc.
Hematology · 300d
Not Cleared Apr 06, 2017
23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia
DEN160026
23AndMe, Inc.
Hematology · 282d

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 510(k) Review Time - PTA Product Code

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 →