# K253722: LIAISON PLEX Gastrointestinal Flex Assay

- Pathway: 510(k) (Traditional)
- Applicant: Luminex Corporation
- Decided: May 19, 2026 after 176 days
- Product code: PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3990
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN130003 (2013). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242367: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel, Biofire Diagnostics, LLC (2024) Summary page 10.

## Indications for use
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.

Source page: https://510kreport.com/device/K253722
Methodology: https://510kreport.com/methodology