Cleared Traditional

LIAISON PLEX Yeast Blood Culture Assay

K240627 · Luminex Corporation · Microbiology

Jun 2024

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K240627 is an FDA 510(k) clearance for the LIAISON PLEX Yeast Blood Culture Assay, a Fungal Organisms, Nucleic Acid-based Assay (Class II — Special Controls, product code PEO), submitted by Luminex Corporation (Northbrook, US). The FDA issued a Cleared decision on June 4, 2024, 90 days after receiving the submission on March 6, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3365.

Submission Details

510(k) Number	K240627 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2024
Decision Date	June 04, 2024
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PEO — Fungal Organisms, Nucleic Acid-based Assay
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3365
Definition	A Qualitative Multiplexed In Vitro Diagnostic Device To Detect And Identify Fungal Organisms In Positive Blood Cultures.