510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PTAClass II

Genetic Variant Detection And Health Risk Assessment System

21 CFR 866.5950 / Immunology
FDA source (opens on fda.gov)

PTA is the FDA product code for Genetic Variant Detection And Health Risk Assessment System, a class II device type, regulated under 21 CFR 866.5950. FDA's definition for this code reads: "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...". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PTA
Device name
Genetic Variant Detection And Health Risk Assessment System
FDA 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.
Regulation
21 CFR 866.5950
Device class
Class II
Review panel
Immunology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code PTA

By decision year
5 clearances under product code PTA with a decision year between 2017 and 2025, 2020 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PTA by decision year
YearClearances
20171
20202
20221
20251

Applicants with the most clearances

Product code PTA
Applicants holding the most 510(k) clearances under product code PTA
ApplicantClearances
23AndMe, Inc.1
Ancestry Genomics, Inc.1
Helix Opco, LLC1
Progenika Biopharma S.A., A Grifols Company1
Targeted Genomics, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code