FDA product code · Microbiology

Enzyme Linked Immunoabsorbent Assay, Rubeola Igg

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

LJBClass I21 CFR 866.3520510(k) exempt11 decisions since 19827 recalls

FDA lists LJB 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. 11 FDA decisions since 1982. 7 recalls name this code, 0 of them Class I. The most-cited predicate is K904083, named by 1 later device.

The qualitative detection of measles specific IgG antibodies in serum or plasma.

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 LJB 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 · LJB

FDA has decided no LJB device since 2007.

Median 510(k) review, days · LJB

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

Recalls per year · LJB

1in 2025

2007high 3 (2008) · low 0 (2007)2026

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

Adverse event reports per year · LJB

2in 2022

2007high 11 (2020) · low 0 (2007)2025

MAUDE reports naming product code LJB, 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	—	0	0
2008	—	3	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	3
2016	—	0	8
2017	—	0	0
2018	—	0	1
2019	—	0	3
2020	—	0	11
2021	—	1	0
2022	—	1	2
2023	—	0	0
2024	—	0	0
2025	—	1	0
2026	—	0	—

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

Planning a device in LJB? 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 866.3520.

GRI Antiserum, Neutralization, Rubeola GRE Antiserum, Fluorescent, Rubeola GRH Antigen, Ha (Including Ha Control), Rubeola GRF Antiserum, Cf, Rubeola PCL Enzyme Linked Immunoabsorbent Assay, Rubeola Igm GRG Antiserum, Hai, Rubeola GRJ Antigen, Cf, (Including Cf Control), Rubeola

Enzyme Linked Immunoabsorbent Assay, Rubeola Igg

Which predicates do LJB devices cite most?

What has FDA decided in LJB lately?

What has been recalled in LJB lately?

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