Cleared Traditional

LIAISON PLEX Gram-Positive Blood Culture Assay

K243490 · Luminex Corporation · Microbiology

Jun 2025

Decision

206d

Days

Class 2

Risk

About This 510(k) Submission

K243490 is an FDA 510(k) clearance for the LIAISON PLEX Gram-Positive Blood Culture Assay, a Gram-positive Bacteria And Their Resistance Markers (Class II — Special Controls, product code PAM), submitted by Luminex Corporation (Northbrook, US). The FDA issued a Cleared decision on June 6, 2025, 206 days after receiving the submission on November 12, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3365.

Submission Details

510(k) Number	K243490 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 12, 2024
Decision Date	June 06, 2025
Days to Decision	206 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PAM — Gram-positive Bacteria And Their Resistance Markers
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3365
Definition	A Qualitive Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram Positive Bacteria And Resistant Markers In Positive Blood Cultures.