510(k) · Cleared
ClearedLIAISON PLEX Yeast Blood Culture Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luminex Corporation · PEO Fungal Organisms, Nucleic Acid-Based Assay
Cleared on Jun 4, 2024 as substantially equivalent to K182690 (Genmark Diagnostics, Incorporated, 2018) after a 90-day review. Its family tree reaches back 4 generations to 2012.
- Decided
- Jun 4, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- PEO
- 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 backK182690 ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP)…Genmark Diagnostics, Incorporated · 2018
- This deviceK240627 LIAISON PLEX Yeast Blood Culture AssayLuminex Corporation · 2024
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 | K182690 | ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel | Genmark Diagnostics, Incorporated | 2018 | — |
| 0 (this device) | K240627 | LIAISON PLEX Yeast Blood Culture Assay | Luminex Corporation | 2024 | — |
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 PEO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K182690 | ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) PanelSummary page 7…ion: 1. Predicate device name(s): GenMark ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) 2. Predicate 510(k) number(s): K182690 3. Comparison with predicate: The following tables compare Luminex’s LIAISON® Yeast Blood Culture Assay to the ePlex Blood… | 2018 |
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 12 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K182690.
How does its category compare?
All PEO devicesPEO Fungal Organisms, Nucleic Acid-Based Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · PEO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PEO
Too few PEO 510(k)s in any year since 2007 to give a median.
Recalls per year · PEO
No recall names PEO since 2007.
Adverse event reports per year · PEO
2in 2025
MAUDE reports naming product code PEO, 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 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LIAISON PLEX Yeast Blood Culture (BCY) Assay is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on the LIAISON PLEX System for simultaneous detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture. The LIAISON PLEX BCY Assay is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system and which contain fungal…
Read the full statement (277 words)
The LIAISON PLEX Yeast Blood Culture (BCY) Assay is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on the LIAISON PLEX System for simultaneous detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture. The LIAISON PLEX BCY Assay is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system and which contain fungal organisms as determined by Gram Stain. The LIAISON PLEX BCY Assay detects and identifies the following fungal organisms:
Candida albicans
Candida auris
Candida dubliniensis
Candida famata
Candida glabrata
Candida guilliermondii
Candida kefyr
Candida krusei
Candida lipolytica
Candida lusitaniae
Candida parapsilosis
Candida tropicalis
Candida haemulonii / duobushaemulonii
Cryptococcus neoformans / gattii
The detection and identification of specific fungal nucleic acids from individuals exhibiting signs and/or symptoms of bloodstream infection aids in the diagnosis of bloodstream infection when used in conjunction with other clinical information. The results from LIAISON PLEX BCY Assay are intended to be interpreted in conjunction with Gram stain results and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
Negative results in the setting of a suspected bloodstream infection may be due to infection with pathogens that are not detected by this test. Positive results do not rule out co-infection with other organisms; the organism(s) detected by LIAISON PLEX BCY Assay may not be the definite cause of disease. Additional laboratory testing (e.g. sub-culturing of positive blood cultures for identification of organisms not detected by LIAISON PLEX BCY Assay, susceptibility testing and differentiation of mixed growth) and clinical presentation must be taken into consideration in the final diagnosis of bloodstream infection.
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/K240627 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240627: LIAISON PLEX Yeast Blood Culture Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240627
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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