FDA product code · Clinical toxicology

Test, Tricyclic Antidepressants, Over The Counter

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

QAWClass II21 CFR 862.3910510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

Intended to measure any of the tricyclic antidepressant drugs in serum or 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 QAW 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 — QAW by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QAW? 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 862.3910.

LFG Radioimmunoassay, Tricyclic Antidepressant Drugs LFI High Pressure Liquid Chromatography, Tricyclic…PVK Test, Tricyclic Antidepressant Drugs…LFH U.V. Spectrometry, Tricyclic Antidepressant…MLK Thin Layer Chromatography, Tricyclic…