510(k) · Cleared
Recalled · Class II · 2024Filmarray Gastrointestinal (GI) Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofire Diagnostics · PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Cleared on May 2, 2014 as substantially equivalent to DEN130003 (Luminex Molecular Diagnostics, Inc., 2013) after a 73-day review. Its family tree reaches back 1 generation to 2013. 24 later devices descend from it. It has been recalled 8 times.
- Decided
- May 2, 2014
- Review
- 73 days
- Class
- Class II
- Product code
- PCH
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN130003 (2013). 24 later devices descend from it, 8 citing it directly.
- Root · 1 generation backDEN130003 Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis…Luminex Molecular Diagnostics, Inc. · 2013
- This deviceK140407 Filmarray Gastrointestinal (GI) PanelBiofire Diagnostics · 2014
- Descendant · cites it directly · 12 of its ownK143005 FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC · 2015 · Recalled
- Descendant · 2 generations on · 9 of its ownK160459 FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchBiofire Diagnostics, LLC · 2016 · Recalled
- Descendant · cites it directly · 4 of its ownK220062 QIAstat-Dx Gastrointestinal Panel 2QIAGEN GmbH · 2024
- Descendant · 3 generations on · 3 of its ownK230404 BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC · 2023 · Recalled
- Descendant · 2 generations on · 2 of its ownK250324 QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH · 2025
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K143005FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC · 2015 · cites it directly12descendants
- K160459FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchBiofire Diagnostics, LLC · 2016 · 2 generations on9descendants
- K220062QIAstat-Dx Gastrointestinal Panel 2QIAGEN GmbH · 2024 · cites it directly4descendants
- K230404BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC · 2023 · 3 generations on3descendants
- K250324QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH · 2025 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN130003 | Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP… | Luminex Molecular Diagnostics, Inc. | 2013 | — |
| 0 (this device) | K140407 | Filmarray Gastrointestinal (GI) Panel | Biofire Diagnostics | 2014 | — |
| +1 | K143005 | FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 | Biofire Diagnostics, LLC | 2015 | 7 |
| +2 | K160459 | FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch | Biofire Diagnostics, LLC | 2016 | 6 |
| +1 | K220062 | QIAstat-Dx Gastrointestinal Panel 2 | QIAGEN GmbH | 2024 | — |
| +3 | K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC | 2023 | 3 |
| +2 | K250324 | QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | DEN130003 | Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP (Tdas) 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. | 2013 |
What descends from it? (24)
See all 248 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143005 | FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 | 2015 | 12 |
| K220062 | QIAstat-Dx Gastrointestinal Panel 2 | 2024 | 4 |
| K143648 | BD MAX Enteric Parasite Panel, BD MAX Instrument | 2015 | 2 |
| K251721 | Xpert GI Panel | 2026 | 0 |
| K251868 | Panther Fusion GI Bacterial Assay | 2025 | 0 |
| K251993 | Panther Fusion GI Expanded Bacterial Assay | 2025 | 0 |
| K182703 | EntericBio Dx Assay | 2019 | 0 |
| K152955 | Great Basin Shiga Toxin Direct Test | 2016 | 0 |
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… |
| Apr 25, 2023 | Class II | Z-2588-2023 | Software design | 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 | Under Investigation by firm | Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results. |
| Feb 1, 2023 | Class II | Z-1253-2023 | Environmental control | 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 result of shipping delays. |
| Aug 8, 2019 | Class II | Z-1451-2020 | Employee error | 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 which could potentially lead to more… |
| Mar 6, 2019 | Class II | Z-1242-2019 | Device Design | Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2014, 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 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…
Read the full statement (400 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140407 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140407: 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/K140407
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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