FDA product code · Clinical toxicology

Test, Methadone, Over The Counter

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

PTGClass II21 CFR 862.3620510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

The methadone test is an in vitro diagnostic test for the qualitative analysis of methadone in human urine.

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, clinical toxicology panel

Twenty years of PTG 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.

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

Planning a device in PTG? 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

Related product codes

Other codes under 21 CFR 862.3620.

PVE Test, Methadone, Employment And Insurance…DMB Gas Chromatography, Methadone DNT Liquid Chromatography, Methadone DPP Free Radical Assay, Methadone DJR Enzyme Immunoassay, Methadone DKR Thin Layer Chromatography, Methadone DIW Hemagglutination Inhibition, Methadone