LIAISON PLEX Gastrointestinal Flex Assay
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K253722 FDA 510(k)
- FDA Product Code
- PCH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3990 FDA 510(k)
- Regulation Number
- 866.3990 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LIAISON PLEX Gastrointestinal Flex Assay is a Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, designed for the qualitative detection and identification of gastrointestinal pathogens. This in vitro diagnostic device targets bacterial, viral, and parasitic nucleic acids in stool samples, enabling simultaneous analysis of up to 24 clinically relevant targets with flexible testing options. It operates as a sample-to-answer assay, integrating sample processing, amplification, and detection within a self-contained cartridge. The device falls under Class II regulatory classification and is intended for microbiological applications in clinical settings.
The assay is performed on the LIAISON PLEX System, a dedicated automated platform that handles sample preparation, nucleic acid extraction, and multiplexed detection. Supplied as a single-use cartridge, the device requires no additional reagents beyond those included in the system. It is not intended for MRI use and must be stored under manufacturer-specified conditions to maintain performance. The LIAISON PLEX Gastrointestinal Flex Assay holds FDA 510(k) clearance (K253722) under the Traditional pathway, with a decision date of May 19, 2026, and is regulated under 21 CFR 866.3990.
Frequently asked questions
What types of gastrointestinal pathogens can the LIAISON PLEX Gastrointestinal Flex Assay detect, and how does it work?
The LIAISON PLEX Gastrointestinal Flex Assay is designed to qualitatively detect and identify bacterial, viral, and parasitic nucleic acids in stool samples. It simultaneously analyzes up to 24 clinically relevant targets, providing a comprehensive analysis in a single test. The assay operates as a sample-to-answer system, meaning it automates the entire process—from sample preparation and nucleic acid extraction to amplification and detection—within a self-contained, single-use cartridge on the LIAISON PLEX platform.
Is the LIAISON PLEX Gastrointestinal Flex Assay intended for reuse, or is it single-use only?
The LIAISON PLEX Gastrointestinal Flex Assay is supplied as a single-use cartridge, meaning each cartridge is designed for one test cycle only. This ensures consistency, sterility, and safety, as the cartridge integrates all necessary reagents and components for a complete sample-to-answer workflow without requiring additional handling or reuse.
What storage conditions are required to maintain the performance of the LIAISON PLEX Gastrointestinal Flex Assay?
The assay must be stored under manufacturer-specified conditions to preserve its performance. While exact details aren’t provided in the data, typical nucleic acid-based assays require protection from extreme temperatures, light exposure, and contamination. Always refer to the included instructions or manufacturer guidelines for precise storage instructions, such as refrigeration or room-temperature storage with desiccants.
How is the LIAISON PLEX Gastrointestinal Flex Assay regulated, and what does its FDA clearance status mean for clinical use?
The LIAISON PLEX Gastrointestinal Flex Assay holds FDA 510(k) clearance (K253722) under the Traditional pathway, classified as a Class II device for microbiological applications. This clearance indicates the device has been determined *substantially equivalent* to a legally marketed predicate device, meaning it meets FDA safety and effectiveness requirements for its intended use in clinical microbiology settings. The clearance does not imply any specific clinical indication but confirms regulatory compliance for use as described.
Can this assay be used with any automated platform, or is it specific to the LIAISON PLEX System?
The LIAISON PLEX Gastrointestinal Flex Assay is exclusively designed for use on the LIAISON PLEX System, a dedicated automated platform. The cartridge integrates seamlessly with this system to handle sample processing, nucleic acid extraction, amplification, and detection—ensuring standardized workflows and results. It is not compatible with other platforms or standalone systems.
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: LIAISON PLEX® Gastrointestinal Flex Assay | Diasorin, LIAISON PLEX® Flex™ Testing | Diasorin, PDF Decision Summary Assay and Instrument
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253722 | Class II | Active |
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Manufacturer
- Manufacturer
- Luminex Corporation
Sources (1)
- FDA 510(k) K253722 24 fields · synced Sep 20, 2026