FDA product code PTA: Genetic Variant Detection And Health Risk Assessment System
PTA is the FDA product code for genetic variant detection and health risk assessment system. It is a Class II device, regulated under 21 CFR 866.5950 and reviewed by the Immunology panel. FDA has cleared 4 510(k) submissions under PTA, 2 in the last five years, from 4 different applicants. The average 510(k) review took 301 days (median 265); 230 days on average over the last three years. 1 De Novo request was granted under it.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Genetic Variant Detection And Health Risk Assessment System |
| Device class | Class II |
| Regulation | 21 CFR 866.5950 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for PTA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 2 | 404 |
| 2022 | 1 | 164 |
| 2025 | 1 | 230 |
Compare with all 510(k) review times · Search every PTA clearance
Top PTA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Targeted Genomics, LLC | 1 | 2025-01-07 |
| Progenika Biopharma S.A., A Grifols Company | 1 | 2022-10-27 |
| Helix Opco, LLC | 1 | 2020-12-23 |
| Ancestry Genomics, Inc. | 1 | 2020-08-13 |
Most recent PTA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241456 | Targeted Genomics, LLC | GlutenID Celiac Genetic Health Risk Test | 2025-01-07 | 230 |
| K221420 | Progenika Biopharma S.A., A Grifols Company | AlphaID At Home Genetic Health Risk Service | 2022-10-27 | 164 |
| K192073 | Helix Opco, LLC | Helix Genetic Health Risk App for late-onset Alzheimers disease | 2020-12-23 | 509 |
| K192944 | Ancestry Genomics, Inc. | AncestryDNA Factor V Leiden Genetic Health Risk Test | 2020-08-13 | 300 |
Recalls for PTA devices
openFDA lists no recalls for product code PTA.
Frequently asked questions
What is FDA product code PTA?
PTA is the FDA product code for genetic variant detection and health risk assessment system. It is a Class II device, regulated under 21 CFR 866.5950 and reviewed by the Immunology panel.
What device class is PTA?
Class II, regulation 21 CFR 866.5950. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PTA?
Across 4 cleared submissions the average was 301 days from receipt to decision (median 265).
Which companies have the most PTA clearances?
Targeted Genomics, LLC (1); Progenika Biopharma S.A., A Grifols Company (1); Helix Opco, LLC (1); Ancestry Genomics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PTA
- Run a recall and safety report across every PTA manufacturer
- Watch product code PTA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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