510(k) · Cleared
ClearedLIAISON PLEX Gram-Negative Blood Culture Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luminex Corporation · PEN Gram-Negative Bacteria And Associated Resistance Markers
Cleared on Apr 18, 2025 as substantially equivalent to K132843 (Nanosphere, Inc., 2014) after a 203-day review. Its family tree reaches back 4 generations to 2012.
- Decided
- Apr 18, 2025
- Review
- 203 days
- Class
- Class II
- Product code
- PEN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN120014 (2012). No later device cites it as a predicate yet.
- Root · 4 generations backDEN120014 Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP)Nanosphere, Inc. · 2012
- 3 generations backK122514 Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid TestNanosphere, Inc. · 2012 · Recalled
- 2 generations backK130914 Filmarray Blood Culture Identification (Bcid) PanelBiofire Diagnostics, Inc. · 2013 · Recalled
- 1 generation backK132843 Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)Nanosphere, Inc. · 2014 · Recalled
- This deviceK243013 LIAISON PLEX Gram-Negative Blood Culture AssayLuminex Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN120014 | Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP) | Nanosphere, Inc. | 2012 | — |
| −3 | K122514 | Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid Test | Nanosphere, Inc. | 2012 | 8 |
| −2 | K130914 | Filmarray Blood Culture Identification (Bcid) Panel | Biofire Diagnostics, Inc. | 2013 | 6 |
| −1 | K132843 | Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) | Nanosphere, Inc. | 2014 | 8 |
| 0 (this device) | K243013 | LIAISON PLEX Gram-Negative 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 PEN? 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 PEN device
- #1 K262168 QIAstat-Dx BCID GN Plus AMR Panelscore 12.1 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K132843 | Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)Summary page 8…uivalence Information: 1. Predicate device name(s): VERIGENE Blood Culture Gram‐Negative (BC‐GN) Nucleic Acid Test 2. Predicate 510(k) number(s): K132843 3. Comparison with predicate: The following tables compare the LIAISON PLEX® Gram‐Negative Blood Culture Assay to the… | 2014 |
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 3 companies; a new generation was cleared every 9 months on median.
- 3 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K132843.
How does its category compare?
All PEN devicesPEN Gram-Negative Bacteria And Associated 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 · PEN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PEN
Too few PEN 510(k)s in any year since 2007 to give a median.
Recalls per year · PEN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PEN
13in 2025
MAUDE reports naming product code PEN, 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 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 5 |
| 2020 | 1 | — | 1 | 4 |
| 2021 | 0 | — | 1 | 15 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (385 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243013: LIAISON PLEX Gram-Negative 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/K243013
Report an extraction error
Are you the manufacturer?
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