FDA product code · Clinical toxicology

Radioimmunoassay, Theophylline

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

LCAClass II21 CFR 862.3880510(k) required5 decisions since 19800 recalls

5 FDA decisions since 1980. No recall names this code.

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 LCA 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 · LCA

FDA has decided no LCA device since 2007.

Median 510(k) review, days · LCA

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

Recalls per year · LCA

No recall names LCA since 2007.

Adverse event reports per year · LCA

No MAUDE report names LCA since 2007.

View these four charts as a table

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

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

Planning a device in LCA? 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 862.3880.

LER Fluorescent Immunoassay, Theophylline LCY U.V. Spectrometry, Theophylline LEW Thin Layer Chromatography, Theophylline LGS Fluorescence Polarization Immunoassay…KLS Enzyme Immunoassay, Theophylline

Radioimmunoassay, Theophylline

What has FDA decided in LCA lately?

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