# K243013: LIAISON PLEX Gram-Negative Blood Culture Assay

- Pathway: 510(k) (Traditional)
- Applicant: Luminex Corporation
- Decided: Apr 18, 2025 after 203 days
- Product code: PEN (Gram-Negative Bacteria And Associated Resistance Markers)
- Device class: 2
- Regulation: 21 CFR 866.3365
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN120014 (2012). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132843: Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), Nanosphere, Inc. (2014) Summary page 8.

## Indications for use
The LIAISON PLEX® Gram-Negative Blood Culture (BCN) Assay, performed using the automated, sample-to-result LIAISON PLEX® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative pathogens and/or selected genetic determinants associated with antimicrobial resistance in positive blood culture bottles. LIAISON PLEX® BCN Assay is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system which contain gram-negative bacteria as determined by Gram stain. The LIAISON PLEX® BCN Assay detects and identifies the following: Resistance Markers: CTX-M (blaCTX-M) IMP (blaIMP) KPC (blaKPC) NDM (blaNDM) OXA (blaOXA) VIM (blaVIM) MCR SME (blaSME) Gram Negative Genera and Species: Enterobacteriaceae / Morganellaceae Acinetobacter baumannii Acinetobacter spp. Citrobacter spp. Enterobacter spp. (1) Escherichia coli (2) Haemophilus influenzae Klebsiella oxytoca Klebsiella pneumoniae Klebsiella variicola Morganella morganii Neisseria meningitidis Proteus spp. Pseudomonas aeruginosa Pseudomonas spp. Salmonella spp. Serratia marcescens Stenotrophomonas maltophilia (1) Due to reclassification, Klebsiella aerogenes will be reported Enterobacter spp. (2) LIAISON PLEX® BCN Assay will not distinguish between Escherichia coli and Shigella spp. (S. dysenteriae, S. boydii, S. flexneri and S. sonnei) LIAISON PLEX® BCN Assay contains targets for the detection of genetic determinants associated with resistance to carbapenems (blaCTX-M, blaIMP, blaKPC, blaNDM, blaOXA48-like, blaVIM, blaSME) to aid in the identification of potentially antimicrobial-resistant organisms in positive blood culture samples. In addition, the panel includes an assay for the detection of the mobilized genetic determinant MCR, an emerging marker of public health importance. The antimicrobial resistance gene or marker detected may or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance gene and marker assays do not indicate susceptibility, as multiple mechanisms of resistance to ß-lactams and colistin exist. LIAISON PLEX® BCN Assay is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections (BSI). LIAISON PLEX® BCN Assay is not intended to monitor treatment of these infections. Sub-culturing of positive blood cultures is necessary to recover organisms for antimicrobial susceptibility testing (AST), for identification of organisms not detected by LIAISON PLEX® BCN Assay, to detect mixed infections that may not be detected by LIAISON PLEX® BCN Assay, for association of antimicrobial resistance marker genes to a specific organism, or for epidemiological typing.

Source page: https://510kreport.com/device/K243013
Methodology: https://510kreport.com/methodology