510(k) · Cleared
ClearedLIAISON PLEX Gastrointestinal Flex Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luminex Corporation · PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Cleared on May 19, 2026 as substantially equivalent to K242367 (Biofire Diagnostics, LLC, 2024) after a 176-day review. Its family tree reaches back 6 generations to 2013.
- Decided
- May 19, 2026
- Review
- 176 days
- Class
- Class II
- Product code
- PCH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN130003 (2013). No later device cites it as a predicate yet.
- Root · 6 generations backDEN130003 Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis…Luminex Molecular Diagnostics, Inc. · 2013
- 5 generations backK140407 Filmarray Gastrointestinal (GI) PanelBiofire Diagnostics · 2014 · Recalled
- 4 generations backK143005 FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC · 2015 · Recalled
- 3 generations backK160459 FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchBiofire Diagnostics, LLC · 2016 · Recalled
- 2 generations backK230404 BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC · 2023 · Recalled
- 1 generation backK242367 BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC · 2024
- This deviceK253722 LIAISON PLEX Gastrointestinal Flex AssayLuminex Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN130003 | Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP… | Luminex Molecular Diagnostics, Inc. | 2013 | — |
| −5 | K140407 | Filmarray Gastrointestinal (GI) Panel | Biofire Diagnostics | 2014 | 8 |
| −4 | K143005 | FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 | Biofire Diagnostics, LLC | 2015 | 7 |
| −3 | K160459 | FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch | Biofire Diagnostics, LLC | 2016 | 6 |
| −2 | K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC | 2023 | 3 |
| −1 | K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC | 2024 | — |
| 0 (this device) | K253722 | LIAISON PLEX Gastrointestinal Flex Assay | Luminex Corporation | 2026 | — |
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 PCH? 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 PCH device
- #1 K220062 QIAstat-Dx Gastrointestinal Panel 2score 16.7 · 2 generations · 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 |
|---|---|---|---|
| * | K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) PanelSummary page 10…cument presents a comprehensive comparative analysis between the LIAISON PLEX® Gastrointestinal Flex Assay and the Biofire® Filmarray® Gastrointestinal Panel (FDA 510(k) K242367). The analysis is structured to fulfill the predicate device comparison requirements of 21 CFR 807.92(a)(3). Table 1 contains a s… | 2024 |
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 4 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K242367.
How does its category compare?
All PCH devicesPCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PCH
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PCH
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PCH
5in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PCH
40in 2025
MAUDE reports naming product code PCH, 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 | 3 | — | 0 | 0 |
| 2014 | 6 | 120 | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 4 | 105 | 0 | 0 |
| 2019 | 4 | 191 | 0 | 4 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 26 |
| 2022 | 2 | — | 0 | 47 |
| 2023 | 1 | — | 1 | 62 |
| 2024 | 3 | 271 | 0 | 45 |
| 2025 | 7 | 89 | 5 | 40 |
| 2026 | 3 | 176 | 0 | — |
What is it indicated for?
The LIAISON PLEX® Gastrointestinal Flex Assay is an automated and qualitative multiplexed test for simultaneous detection and identification of common pathogenic bacteria, viruses, and parasites from liquid or soft stool preserved in Cary-Blair or modified Cary-Blair medium and additionally for parasites, from liquid or soft stool preserved in alcohol-based formalin-free parasite fixative (e.g., EcoFix®, Total-Fix®) collected from individuals with signs…
Read the full statement (351 words)
The LIAISON PLEX® Gastrointestinal Flex Assay is an automated and qualitative multiplexed test for simultaneous detection and identification of common pathogenic bacteria, viruses, and parasites from liquid or soft stool preserved in Cary-Blair or modified Cary-Blair medium and additionally for parasites, from liquid or soft stool preserved in alcohol-based formalin-free parasite fixative (e.g., EcoFix®, Total-Fix®) collected from individuals with signs and symptoms of gastrointestinal infection. The test is performed on the automated LIAISON PLEX® System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and array hybridization to detect specific gastrointestinal microbial nucleic acid gene sequences associated with the pathogenic bacteria, viruses, and parasites:
Bacteria:
Campylobacter spp. (C. coli/C. jejuni/C. lari/C. upsaliensis)
Clostridioides difficile (tcdA/tcdB)
Enterotoxigenic Escherichia coli (ETEC) LT/ST
Plesiomonas shigelloides
Salmonella spp.
Shiga-like toxin-producing Escherichia coli (STEC) stx1
Shiga-like toxin-producing Escherichia coli (STEC) stx2
Shigella/Enteroinvasive Escherichia coli (EIEC)
Vibrio cholerae
Vibrio spp. (V. parahaemolyticus/V. vulnificus)
Yersinia enterocolitica
Viruses:
Adenovirus F40/41
Astrovirus
Norovirus GI/GII
Rotavirus A
Sapovirus I/II/IV/V
Parasites:
Blastocystis sp.
Cryptosporidium spp.
Cyclospora cayetanensis
Dientamoeba fragilis
Entamoeba histolytica
Giardia lamblia (also known as G. intestinalis and G. duodenalis)
Microsporidia (Encephalitozoon hellem/Encephalitozoon intestinalis/Enterocytozoon bieneusi)
Strongyloides stercoralis
The LIAISON PLEX Gastrointestinal Flex Assay is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, and results are meant to be used in conjunction with other clinical, laboratory, and epidemiological information; however, it is not to be used to monitor these infections.
Concomitant culture is necessary for organism recovery and further typing of bacterial agents.
This device is not intended to monitor C. difficile infection.
LIAISON PLEX Gastrointestinal Flex Assay results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out co-infection with other organisms that are not detected by this test and may not be the sole or definitive cause of patient illness. Negative LIAISON PLEX Gastrointestinal Flex Assay results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn’s disease.
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/K253722 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253722: LIAISON PLEX Gastrointestinal Flex Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253722
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026