510(k) · Cleared

Cleared

Murex Rub-EX

K954920510(k) TraditionalCleared Aug 21, 1996300-day reviewClass II21 CFR 866.3510

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Murex Diagnostics, Inc. · LQN Latex Agglutination Assay, Rubella

Cleared on Aug 21, 1996 after a 300-day review. The FDA summary names its predicate without a number.

Decided: Aug 21, 1996
Review: 300 days
Class: Class II
Product code: LQN
Recalls: None
Predicates: 0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K954920Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	—	Rubascan Named without a submission number			—
*	—	Rubalex Named without a submission number			—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All LQN devices

LQN Latex Agglutination Assay, Rubella: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LQN

FDA has decided no LQN device since 2007.

Median 510(k) review, days · LQN

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

Recalls per year · LQN

No recall names LQN since 2007.

Adverse event reports per year · LQN

1in 2009

2007high 1 (2009) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	1
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	—	—

What is it indicated for?

The Murex Rib-ex test is a rapid latex agglutination test for the qualitative and semi-quantitative determination of rubella antibodies in serum.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K954920 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954920: Murex Rub-EX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954920

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026