510(k) · Cleared
Recalled · Class II · 2024FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch
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 Apr 1, 2016 as substantially equivalent to K143005 (Biofire Diagnostics, LLC, 2015) after a 42-day review. Its family tree reaches back 3 generations to 2013. 9 later devices descend from it. It has been recalled 6 times.
- Decided
- Apr 1, 2016
- Review
- 42 days
- Class
- Class II
- Product code
- PCH
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN130003 (2013). 9 later devices descend from it, 4 citing it directly.
- Root · 3 generations backDEN130003 Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis…Luminex Molecular Diagnostics, Inc. · 2013
- 2 generations backK140407 Filmarray Gastrointestinal (GI) PanelBiofire Diagnostics · 2014 · Recalled
- 1 generation backK143005 FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC · 2015 · Recalled
- This deviceK160459 FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchBiofire Diagnostics, LLC · 2016
- Descendant · cites it directly · 3 of its ownK230404 BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC · 2023 · Recalled
- Descendant · 2 generations on · 2 of its ownK242367 BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC · 2024
- Descendant · cites it directly · 2 of its ownK170308 BD MAX Extended Enteric Bacterial Panel, BD MAX SystemBecton, Dickinson and Company · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK214122 BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial…Becton, Dickinson and Company · 2022
- Descendant · 3 generations on · 0 of its ownK253722 LIAISON PLEX Gastrointestinal Flex AssayLuminex Corporation · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K230404BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC · 2023 · cites it directly3descendants
- K242367BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC · 2024 · 2 generations on2descendants
- K170308BD MAX Extended Enteric Bacterial Panel, BD MAX SystemBecton, Dickinson and Company · 2017 · cites it directly2descendants
- K214122BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial PanelBecton, Dickinson and Company · 2022 · 2 generations on1descendant
- K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex Corporation · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN130003 | Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP… | Luminex Molecular Diagnostics, Inc. | 2013 | — |
| −2 | K140407 | Filmarray Gastrointestinal (GI) Panel | Biofire Diagnostics | 2014 | 8 |
| −1 | K143005 | FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 | Biofire Diagnostics, LLC | 2015 | 7 |
| 0 (this device) | K160459 | FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch | Biofire Diagnostics, LLC | 2016 | — |
| +1 | K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC | 2023 | 3 |
| +2 | K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC | 2024 | — |
| +1 | K170308 | BD MAX Extended Enteric Bacterial Panel, BD MAX System | Becton, Dickinson and Company | 2017 | 1 |
| +2 | K214122 | BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel | Becton, Dickinson and Company | 2022 | — |
| +3 | K253722 | LIAISON PLEX Gastrointestinal Flex Assay | Luminex Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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 |
|---|---|---|---|
| * | K143005 | FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0Summary page 5…de Name: FilmArray Gastrointestinal (GI) Panel Classification Name: Gastrointestinal microorganism multiplex nucleic acid-based assay (21 CFR 866.3990) Predicate Device: K143005 – FilmArray Gastrointestinal (GI) Panel Intended Use: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nuc… | 2015 |
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 |
| 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… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K230404 (Biofire Diagnostics, LLC, 2023) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K143005.
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. 2016, 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 (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…
Read the full statement (402 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160459: FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160459
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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