# K242367: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

- Pathway: 510(k) (Traditional)
- Applicant: Biofire Diagnostics, LLC
- Decided: Nov 7, 2024 after 90 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: 5 generations back to DEN130003 (2013). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230404: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel, Biofire Diagnostics, LLC (2023) Summary page 6.

## Most influential descendants
- K253722: LIAISON PLEX Gastrointestinal Flex Assay (2026), 0 descendants of its own
- K243885: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid (2025), 0 descendants of its own

## Indications for use
The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems. The BIOFIRE GI Panel is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following bacteria (including several diarrheagenic E. coli/Shigella pathotypes), parasites, and viruses are identified using the BIOFIRE GI Panel: • Campylobacter (C. jejuni/C. coli/C. upsaliensis) • Clostridium difficile (C. difficile) toxin A/B • Plesiomonas shigelloides • Salmonella • Vibrio (V. parahaemolyticus/V. vulnificus/ V. cholerae), including specific identification of Vibrio cholerae • Yersinia enterocolitica • Enteroaggregative Escherichia coli (EAEC) • Enteropathogenic Escherichia coli (EPEC) • Enterotoxigenic Escherichia coli (ETEC) lt/st • Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2 (including specific identification of the E. coli O157 serogroup within STEC) • Shigella/ Enteroinvasive Escherichia coli (EIEC) • Cryptosporidium • Cyclospora cayetanensis • Entamoeba histolytica • Giardia lamblia (also known as G. intestinalis and G. duodenalis) • Adenovirus F 40/41 • Astrovirus • Norovirus GI/GII • Rotavirus A • Sapovirus (Genogroups I, II, IV, and V) The BIOFIRE GI Panel 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 data. Positive results do not rule out co-infection with organisms not included in the BIOFIRE GI Panel. The agent detected may not be the definite cause of the disease. Concomitant culture is necessary for organism recovery and further typing of bacterial agents. This device is not intended to monitor or guide treatment for C. difficile infection. Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for E. coli O157, Plesiomonas shigelloides, Yersinia enterocolitica, Astrovirus, and Rotavirus A were established primarily with retrospective clinical specimens. Performance characteristics for Entamoeba histolytica, and Vibrio (V. parahaemolyticus, V. vulnificus, and Vibrio cholerae) were established primarily using contrived clinical specimens. Negative BIOFIRE GI Panel 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. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.

Source page: https://510kreport.com/device/K242367
Methodology: https://510kreport.com/methodology