# K143005: FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Biofire Diagnostics, LLC
- Decided: Feb 19, 2015 after 122 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: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN130003 (2013). 2 ancestors in all.
12 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140407: Filmarray Gastrointestinal (GI) Panel, Biofire Diagnostics (2014) Summary page 5.

## Most influential descendants
- K160459: FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch (2016), 9 descendants of its own
- K230404: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (2023), 3 descendants of its own
- K242367: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (2024), 2 descendants of its own
- K170308: BD MAX Extended Enteric Bacterial Panel, BD MAX System (2017), 2 descendants of its own
- K214122: BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel (2022), 1 descendant of its own

## Recalls of this device
- May 16, 2024 · Class II · Z-2514-2024: Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
- Jan 26, 2024 · Class II · Z-1140-2024: Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
- Nov 27, 2023 · Class II · Z-0703-2024: A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no tr
- Apr 25, 2023 · Class II · Z-2588-2023: The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE¿ FILMARRAY¿ Gastrointestinal (GI) Panel
- Mar 8, 2023 · Class II · Z-1392-2023: Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
- Feb 1, 2023 · Class II · Z-1253-2023: Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a res
- Aug 8, 2019 · Class II · Z-1451-2020: Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided whi

## Indications for use
The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems. The FilmArray 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 FilmArray 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 FilmArray 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 FilmArray 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 FilmArray 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/K143005
Methodology: https://510kreport.com/methodology