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LIAISON PLEX Yeast Blood Culture Assay

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240627

by Luminex Corporation

Identifiers

510(k) Number
K240627 FDA 510(k)
FDA Product Code
PEO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3365 FDA 510(k)
Regulation Number
866.3365 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The LIAISON PLEX Yeast Blood Culture Assay is a qualitative nucleic acid multiplex in vitro diagnostic test designed for the simultaneous detection and identification of multiple potentially pathogenic fungal organisms. Classified as a nucleic acid-based assay for fungal organisms, it operates within the Microbiology specialty and falls under Device Class II regulatory classification. The assay leverages molecular techniques to provide rapid and specific fungal identification from positive blood culture samples.

This assay is intended for use exclusively on the LIAISON PLEX System and is performed directly on positive blood culture samples. It is not sterile for patient use but is supplied as a reagent kit for laboratory processing. The device holds FDA 510(k) clearance under the Traditional pathway, with a Substantially Equivalent determination by the Microbiology (MI) Advisory Committee. No MRI safety or single-use/reusable specifications are noted in the regulatory data.

Frequently asked questions

What types of fungal organisms can the LIAISON PLEX Yeast Blood Culture Assay detect and identify simultaneously?

The LIAISON PLEX Yeast Blood Culture Assay is a multiplex nucleic acid test designed to simultaneously detect and identify multiple potentially pathogenic fungal organisms from positive blood culture samples. While the exact list of organisms isn’t specified in the provided data, it is classified as a fungal organism assay and operates via molecular techniques for rapid identification.

Is this assay intended for direct patient use, or is it meant for laboratory processing only?

This assay is not sterile for patient use and is supplied as a reagent kit exclusively for laboratory processing. It is intended to be used directly on positive blood culture samples within the LIAISON PLEX System, meaning it requires a clinical microbiology lab setting for operation.

How is the LIAISON PLEX Yeast Blood Culture Assay supplied, and is it single-use or reusable?

The assay is supplied as a reagent kit for laboratory use, not as a sterile device for direct patient application. The data does not specify whether the components (e.g., cartridges or reagents) are single-use or reusable, but the context implies it is designed for one-time use per test in a clinical lab setting, as is standard for molecular diagnostics.

What system is required to run the LIAISON PLEX Yeast Blood Culture Assay, and can it be used with other platforms?

The assay is exclusively designed for use on the LIAISON PLEX System by Luminex Corporation. It cannot be used with other diagnostic platforms, as its molecular detection and identification processes are integrated into this specific system.

What regulatory pathway was followed for FDA clearance, and which advisory committee reviewed it?

The LIAISON PLEX Yeast Blood Culture Assay received FDA clearance through the Traditional 510(k) pathway with a Substantially Equivalent (SESE) determination. The review was conducted by the Microbiology (MI) Advisory Committee, which specializes in evaluating microbiological diagnostic devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF K240627 - Food and Drug Administration, PDF June 4, 2024 Luminex Corporation Sarah Herzog Sr. Regulatory Affairs ..., Performance of the LIAISON PLEX yeast blood culture assay for ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Luminex Corporation

Sources (1)

  • FDA 510(k) K240627 24 fields · synced Oct 6, 2026