LIAISON PLEX Respiratory Flex Assay
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233410 FDA 510(k)
- FDA Product Code
- QOF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3981 FDA 510(k)
- Regulation Number
- 866.3981 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LIAISON PLEX Respiratory Flex Assay is a Multi-Target Respiratory Specimen Nucleic Acid Test designed for the simultaneous detection and identification of multiple microbial agents, including SARS-CoV-2 and other respiratory pathogens. This in vitro diagnostic device employs multiplexed nucleic acid amplification to analyze nasopharyngeal swab samples, enabling comprehensive pathogen profiling in a single assay. It is intended for use in clinical microbiology settings to aid in the diagnosis of respiratory infections.
The assay is supplied as a self-contained cartridge for use on the LIAISON® instrument, requiring no additional sample preparation beyond standard nasopharyngeal swab collection. It is intended for single-use and is not sterile as it is not intended for direct patient contact. The device is FDA-cleared under a 510(k) submission (K233410) and classified as a Class II medical device under regulation 866.3981. Storage and handling instructions are specified in the accompanying documentation, with compatibility confirmed for use with the LIAISON® system.
Frequently asked questions
What types of respiratory pathogens can the LIAISON PLEX Respiratory Flex Assay detect simultaneously, and how does this benefit clinical workflows?
The LIAISON PLEX Respiratory Flex Assay is designed to simultaneously detect and identify multiple microbial agents, including SARS-CoV-2 alongside other respiratory pathogens. This multiplexed nucleic acid amplification approach allows clinicians to analyze nasopharyngeal swab samples for a broad spectrum of pathogens in a single test, reducing the need for multiple individual assays. This streamlines diagnostic workflows, minimizes turnaround time, and improves efficiency in clinical microbiology settings by providing comprehensive pathogen profiling in one assay.
Is the LIAISON PLEX Respiratory Flex Assay intended for direct patient contact, and what does this mean for its sterility and reuse?
No, the LIAISON PLEX Respiratory Flex Assay is not intended for direct patient contact, which is why it is not sterile. It is supplied as a single-use cartridge designed exclusively for use on the LIAISON® instrument. This means each cartridge is intended for one test cycle only, and reuse is not recommended or supported by the manufacturer. The lack of sterility is explicitly noted because the device is not designed to enter the patient’s body or come into direct contact with sterile environments.
How is the LIAISON PLEX Respiratory Flex Assay supplied, and what sample preparation is required before testing?
The assay is supplied as a self-contained cartridge for use on the LIAISON® instrument. No additional sample preparation is required beyond standard nasopharyngeal swab collection. The cartridge is pre-packaged and ready for immediate use, eliminating the need for manual extraction or processing steps, which simplifies workflows in clinical settings.
What regulatory pathway was followed for FDA clearance of the LIAISON PLEX Respiratory Flex Assay, and what does this classification mean for its use?
The LIAISON PLEX Respiratory Flex Assay was cleared through the FDA 510(k) pathway under submission number K233410, with a decision dated March 1, 2024. It is classified as a Class II medical device under regulation 866.3981, which indicates it poses moderate risk and requires general controls (e.g., performance standards, labeling requirements) to ensure safety and effectiveness. This classification aligns with its use as an in vitro diagnostic device for detecting respiratory pathogens in clinical microbiology settings.
What instrument compatibility does the LIAISON PLEX Respiratory Flex Assay require, and are there any special storage or handling considerations?
The assay is exclusively compatible with the LIAISON® system and must be used on this instrument. While the data does not specify detailed storage conditions, the manufacturer’s accompanying documentation includes storage and handling instructions to ensure proper functionality. These likely cover environmental factors like temperature and humidity, as well as shelf-life considerations. Clinicians should refer to the provided documentation for precise guidelines to maintain assay performance.
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® Respiratory Flex Assay | Diasorin, PDF Flex - Food and Drug Administration, LIAISON PLEX® Flex™ Testing | Diasorin
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233410 | Class II | Active |
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Manufacturer
- Manufacturer
- Luminex Corporation
Sources (1)
- FDA 510(k) K233410 24 fields · synced Oct 6, 2026