510(k) · Cleared
Recalled · Class II · 2024BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofire Diagnostics, LLC · PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Cleared on Mar 16, 2023 as substantially equivalent to K160459 (Biofire Diagnostics, LLC, 2016) after a 29-day review. Its family tree reaches back 4 generations to 2013. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 16, 2023
- Review
- 29 days
- Class
- Class II
- Product code
- PCH
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN130003 (2013). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backDEN130003 Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis…Luminex Molecular Diagnostics, Inc. · 2013
- 3 generations backK140407 Filmarray Gastrointestinal (GI) PanelBiofire Diagnostics · 2014 · Recalled
- 2 generations backK143005 FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC · 2015 · Recalled
- 1 generation backK160459 FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchBiofire Diagnostics, LLC · 2016 · Recalled
- This deviceK230404 BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC · 2023
- Descendant · cites it directly · 2 of its ownK242367 BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK253722 LIAISON PLEX Gastrointestinal Flex AssayLuminex Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK243885 BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidBiofire Diagnostics, LLC · 2025
Most influential descendants
Showing 3 of 3 · See all- K242367BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC · 2024 · cites it directly2descendants
- K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex Corporation · 2026 · 2 generations on0descendants
- K243885BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidBiofire Diagnostics, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN130003 | Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP… | Luminex Molecular Diagnostics, Inc. | 2013 | — |
| −3 | K140407 | Filmarray Gastrointestinal (GI) Panel | Biofire Diagnostics | 2014 | 8 |
| −2 | K143005 | FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 | Biofire Diagnostics, LLC | 2015 | 7 |
| −1 | K160459 | FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch | Biofire Diagnostics, LLC | 2016 | 6 |
| 0 (this device) | K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC | 2023 | — |
| +1 | K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC | 2024 | — |
| +2 | K253722 | LIAISON PLEX Gastrointestinal Flex Assay | Luminex Corporation | 2026 | — |
| +2 | K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid | Biofire Diagnostics, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 |
|---|---|---|---|
| * | K160459 | FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchSummary page 6…n: Purpose The content of this Special 510(k) submission is limited to obtaining FDA clearance for the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (BIOFIRE GI Panel) (K160459) with a software update to mitigate the erroneous interpretation of a non-specific Crypt 2 assay product. According to the requi… | 2016 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | 2024 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 2024 | Class II | Z-2514-2024 | Under Investigation by firm | Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium. |
| Jan 26, 2024 | Class II | Z-1140-2024 | Under Investigation by firm | Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel. |
| Nov 27, 2023 | Class II | Z-0703-2024 | Process control | 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 treatment, delay of treatment, and may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K242367 (Biofire Diagnostics, LLC, 2024) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K160459.
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. 2023, 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 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.…
Read the full statement (406 words)
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)
• Clostridiodes (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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230404: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230404
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026