510(k) · Cleared
ClearedLIAISON PLEX Gram-Positive Blood Culture Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luminex Corporation · PAM Gram-Positive Bacteria And Their Resistance Markers
Cleared on Jun 6, 2025 as substantially equivalent to K122514 (Nanosphere, Inc., 2012) after a 206-day review. Its family tree reaches back 2 generations to 2012.
- Decided
- Jun 6, 2025
- Review
- 206 days
- Class
- Class II
- Product code
- PAM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN120014 (2012). No later device cites it as a predicate yet.
- Root · 2 generations backDEN120014 Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP)Nanosphere, Inc. · 2012
- 1 generation backK122514 Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid TestNanosphere, Inc. · 2012 · Recalled
- This deviceK243490 LIAISON PLEX Gram-Positive Blood Culture AssayLuminex Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN120014 | Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP) | Nanosphere, Inc. | 2012 | — |
| −1 | K122514 | Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid Test | Nanosphere, Inc. | 2012 | 8 |
| 0 (this device) | K243490 | LIAISON PLEX Gram-Positive Blood Culture Assay | Luminex Corporation | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PAM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PAM device
- #1 K254194 QIAstat-Dx BCID GPF Plus AMR Panelscore 12.7 · 4 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122514 | Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid TestSummary page 9…uivalence Information: 1. Predicate device name(s): VERIGENE Blood Culture Gram-Positive (BC-GP) Nucleic Acid Test 2. Predicate 510(k) number(s): K122514 3. Comparison with predicate: The following tables compare the LIAISON PLEX® Gram-Positive Blood Culture Assay to the… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 12.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 3 other devices also cite its predicate K122514.
How does its category compare?
All PAM devicesPAM Gram-Positive Bacteria And Their Resistance Markers: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PAM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PAM
Too few PAM 510(k)s in any year since 2007 to give a median.
Recalls per year · PAM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PAM
75in 2025
MAUDE reports naming product code PAM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 3 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 1 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 1 | 106 |
| 2024 | 0 | — | 0 | 422 |
| 2025 | 1 | — | 0 | 75 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (359 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243490 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243490: LIAISON PLEX Gram-Positive Blood Culture Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243490
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026