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LIAISON PLEX Gram-Positive Blood Culture Assay

FDA 510(k)

Class II (US FDA 510(k))

510(k) K243490

by Luminex Corporation

Identifiers

510(k) Number
K243490 FDA 510(k)
FDA Product Code
PAM 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 Gram-Positive Blood Culture Assay is a qualitative multiplexed in vitro diagnostic molecular test designed for the simultaneous detection and identification of gram-positive pathogens and genetic markers associated with antimicrobial resistance. It falls under the classification of Gram-Positive Bacteria and Their Resistance Markers, as defined by regulatory nomenclature (OpenFDA: 866.3365).

This assay is intended for use with positive blood culture bottles and operates on the automated LIAISON PLEX System, providing a sample-to-result workflow. It is classified as a Class II device under FDA regulations (K243490) and is supplied as a single-use diagnostic tool. The device requires no specific MRI safety considerations and is regulated under the FDA’s 510(k) clearance pathway, with a decision date of June 6, 2025.

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: Performance of the LIAISON PLEX gram-positive blood culture assay for ..., LIAISON PLEX Gram-Positive Blood Culture Assay (K243490) — FDA 510(k ..., LIAISON PLEX - DiaSorin

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Luminex Corporation

Sources (1)

  • FDA 510(k) K243490 24 fields · synced Oct 6, 2026