# K243490: LIAISON PLEX Gram-Positive Blood Culture Assay

- Pathway: 510(k) (Traditional)
- Applicant: Luminex Corporation
- Decided: Jun 6, 2025 after 206 days
- Product code: PAM (Gram-Positive Bacteria And Their 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: 2 generations back to DEN120014 (2012). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122514: Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid Test, Nanosphere, Inc. (2012) Summary page 9.

## Indications for use
The LIAISON PLEX® Gram-Positive Blood Culture Assay (BCP), 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-positive pathogens and/or selected genetic determinants associated with antimicrobial resistance in positive blood culture bottles. BCP is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria as determined by Gram stain. The BCP Assay detects and identifies the following: Gram Positive Resistance Markers(a): mecA/mecC vanA vanB Genera and Species: Bacillus spp. Enterococcus faecalis Enterococcus faecium Listeria spp. Staphylococcus spp. Staphylococcus aureus Staphylococcus epidermidis Staphylococcus lugdunensis Streptococcus spp. Streptococcus agalactiae Streptococcus anginosus group Streptococcus pneumoniae Streptococcus pyogenes (a) Negative results for antimicrobial resistance genes do not indicate bacterial susceptibility as there are multiple mechanisms that can contribute to resistance. The LIAISON PLEX® BCP Assay contains targets for the detection of genetic determinants associated with resistance to methicillin (mecA/C) and vancomycin (vanA and vanB) to aid in the identification of potentially antimicrobial-resistant organisms in positive blood culture samples. In mixed growth, the LIAISON PLEX BCP Assay does not specifically attribute vanA/vanB-mediated vancomycin resistance to either E. faecalis or E. faecium, or mecA/mecC-mediated methicillin resistance to either Staphylococcus spp., S. aureus, S. epidermidis or S. lugdunensis. 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 methicillin and vancomycin resistance exist. The LIAISON PLEX® BCP Assay is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections (BSI). The LIAISON PLEX® BCP Assay is not intended to monitor 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 the LIAISON PLEX BCP Assay, to detect mixed infections that may not be detected by the LIAISON PLEX BCP Assay, for association of antimicrobial resistance genes to a specific organism, or for epidemiological typing.

Source page: https://510kreport.com/device/K243490
Methodology: https://510kreport.com/methodology