# K140407: Filmarray Gastrointestinal (GI) Panel

- Pathway: 510(k) (Traditional)
- Applicant: Biofire Diagnostics
- Decided: May 2, 2014 after 73 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: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN130003 (2013). 1 ancestor in all.
24 later devices descend from it; 8 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130003: Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP (Tdas), Luminex Molecular Diagnostics, Inc. (2013). Our OCR of the scanned summary read K121454, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130003, Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data… (Luminex Molecular Diagnostics, Inc.), granted Jan 14, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K143005: FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 (2015), 12 descendants of its own
- K160459: FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch (2016), 9 descendants of its own
- K220062: QIAstat-Dx Gastrointestinal Panel 2 (2024), 4 descendants of its own
- K230404: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (2023), 3 descendants of its own
- K250324: QIAstat-Dx GI Panel 2 Mini B (2025), 2 descendants 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
- Mar 6, 2019 · Class II · Z-1242-2019: Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified.

## Indications for use
The FilmArray Gastrointestinal (G1) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with the FilmArray instrument. 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/Shigelia pathotypes), parasites, and viruses are identified using the FilmArray 01 Panel: * C'ampylobacter (C ]ejuni/C. coli/C upsaliensis) * Clostridium djfficile (C.djfficile) toxin A[B * J'iesiomionas shigelloldes * Salmonella * Vibrio (V parahaemolyticusV. vuli(icus/V. cholerac) including specific identification of Vlbrio cholerae * Yersinia enterocolitica * Enteroaggregative Escherichia colt (EAEC) * Enteropathogenic Escherichia colt (EPEC) * Enterotoxigenic Escherichia colt (ETEC) it/st * Shiga-like toxin-producing Escherichia coii (STEC) stxJ/stx2 (including specific identification of the . colt 0 15 7 serogroup within STEC) * Shigel/a/EnteroinvasiveEscherichia coil (EJEC) * Cryptosporidium * Cyclospora cayetanensis ** En/amoeba histolytica * Giardia lamiblia (also known as G.intestinalis and G. duodenalis) * Adenovirus F 40/41 * Astrovirus * Norovirus G1/GIl * Rotavirus A * Sapovirus (Genogroups 1,11, 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.dificile infection. Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for E. coi 0157, Plesiomionas shigeiloides, Yersinia enterocolitica, Astrovirus, and Rotavirus A were established primarily with retrospective clinical specimens. Performance characteristics for Entamioeba histolytica, and Vibrio (V parahoernolyticus, 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/K140407
Methodology: https://510kreport.com/methodology