PTA

Genetic Variant Detection And Health Risk Assessment System

Product code

PTA

Device name

Genetic Variant Detection And Health Risk Assessment System

Device class

Class 2

21 CFR

21 CFR 866.5950

Medical specialty

Immunology

Marketing pathway

510(K) Exempt

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

5 (all years; only the last 3 years are listed here)

FDA classification 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 person’s overall risk of developing a disease.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-01-07.