Cleared Traditional

LIAISON PLEX Gram-Negative Blood Culture Assay

K243013 · Luminex Corporation · Microbiology

Apr 2025

Decision

203d

Days

Class 2

Risk

About This 510(k) Submission

K243013 is an FDA 510(k) clearance for the LIAISON PLEX Gram-Negative Blood Culture Assay, a Gram-negative Bacteria And Associated Resistance Markers (Class II — Special Controls, product code PEN), submitted by Luminex Corporation (Northbrook, US). The FDA issued a Cleared decision on April 18, 2025, 203 days after receiving the submission on September 27, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3365.

Submission Details

510(k) Number	K243013 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2024
Decision Date	April 18, 2025
Days to Decision	203 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PEN — Gram-negative Bacteria And Associated Resistance Markers
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3365
Definition	A Qualitative Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram-negative Bacteria And Resistance Markers In Positive Blood Cultures.