FDA product code · Microbiology

Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

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

LGCClass II21 CFR 866.3305510(k) required38 decisions since 19817 recalls

38 FDA decisions since 1981. 7 recalls name this code, 0 of them Class I. The most-cited predicate is K000238, named by 14 later devices.

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, microbiology panel

Twenty years of LGC 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 · LGC

FDA has decided no LGC device since 2007.

Median 510(k) review, days · LGC

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

Recalls per year · LGC

1in 2022

2007high 4 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LGC

1in 2024

2007high 4 (2007) · low 0 (2008)2025

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

View these four charts as a table

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

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

Planning a device in LGC? 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 866.3305.

MXJ Enzyme Linked Immunosorbent Assay, Herpes…LKC Antigens, Indirect Hemagglutination (Iha)…GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2 MYF Enzyme Linked Immunosorbent Assay, Herpes…GQN Antigen, Cf (Including Cf Control)…OQO Herpes Simplex Virus Nucleic Acid…GQO Antisera, Cf, Herpesvirus Hominis 1,2 GQM Antisera, Neutralization, Herpesvirus Hominis

Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

Which predicates do LGC devices cite most?

Which LGC devices have the deepest lineage?

What has FDA decided in LGC lately?

What has been recalled in LGC lately?

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