FDA product code · Immunology

Genetic Variant Detection And Health Risk Assessment System

Name: FDA decisions, review times, recalls and adverse event reports for product code PTA
Creator: 510(k) Report

PTAClass II21 CFR 866.5950510(k) exempt5 decisions since 20200 recalls

FDA lists PTA as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 5 FDA decisions since 2020. 510(k) reviews decided 2021–2025 took a median of 197 days (half between 181 and 214). No recall names this code. The most-cited predicate is DEN160026, named by 3 later devices.

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…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, immunology panel

Twenty years of PTA at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PTA

1in 2025

2007high 2 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PTA

Too few PTA 510(k)s in any year since 2007 to give a median.

Recalls per year · PTA

No recall names PTA since 2007.

Adverse event reports per year · PTA

1in 2024

2007high 4 (2020) · low 0 (2007)2025

MAUDE reports naming product code PTA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	2	—	4
2021	0	—	0
2022	1	—	0
2023	0	—	0
2024	0	—	1
2025	1	—	0
2026	0	—	—

FIG. 1 — PTA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PTA? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Genetic Variant Detection And Health Risk Assessment System

Which predicates do PTA devices cite most?

Which PTA devices have the deepest lineage?

What has FDA decided in PTA lately?