LIAISON PLEX Gram-Negative Blood Culture Assay
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243013 FDA 510(k)
- FDA Product Code
- PEN 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-Negative Blood Culture Assay is a qualitative multiplex in vitro diagnostic device designed to detect 19 pathogenic gram-negative bacterial species or families from positive blood cultures. It employs a DNA array-based assay to identify organisms responsible for most gram-negative bloodstream infections (BSIs).
This assay is intended for use on the automated LIAISON PLEX System, providing a sample-to-result workflow. It is classified as a Class II device under FDA regulations (866.3365) and has received FDA 510(k) clearance through a Traditional pathway. The device is not described as single-use or reusable, sterility, or MRI safety in the provided data.
Frequently asked questions
What clinical scenario is the LIAISON PLEX Gram-Negative Blood Culture Assay designed to address?
This assay is specifically designed to identify 19 pathogenic gram-negative bacterial species or families from positive blood cultures, helping clinicians diagnose the most common causes of gram-negative bloodstream infections (BSIs). It streamlines the workflow by providing rapid identification directly from positive blood cultures, enabling faster targeted treatment decisions.
How does the LIAISON PLEX Gram-Negative Blood Culture Assay differ from traditional blood culture identification methods?
Unlike traditional culture-based methods that require hours or days to grow and identify bacteria, this assay uses a DNA array-based technology on the automated LIAISON PLEX System to deliver results more efficiently. It detects multiple gram-negative pathogens simultaneously, reducing the need for additional testing and accelerating the identification process for clinicians.
Is the LIAISON PLEX Gram-Negative Blood Culture Assay compatible with any specific laboratory equipment?
Yes, the assay is designed exclusively for use on the automated LIAISON PLEX System, which provides a fully integrated sample-to-result workflow. This ensures seamless integration with the system’s processing capabilities, optimizing workflow efficiency in microbiology laboratories.
What regulatory pathway was followed for the FDA clearance of this device?
The LIAISON PLEX Gram-Negative Blood Culture Assay received FDA 510(k) clearance through the Traditional pathway, demonstrating substantial equivalence to a predicate device. The clearance was granted under the Microbiology advisory committee (MI) and classified as a Class II device, adhering to FDA regulations (866.3365).
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-negative blood culture assay for ..., LIAISON PLEX® Bloodstream Infection Portfolio | Diasorin, LIAISON PLEX Gram-Negative Blood Culture Assay by Luminex Corporation ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243013 | Class II | Active |
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Manufacturer
- Manufacturer
- Luminex Corporation
Sources (1)
- FDA 510(k) K243013 24 fields · synced Oct 6, 2026