Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
FDA product code PCH · Class II (moderate risk) · 21 CFR 866.3990 · Microbiology
A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.
37510(k) clearances
0PMA approvals
24recalls
Manufacturers
- Luminex Molecular Diagnostics, Inc. 7
- BioFire Diagnostics, LLC 6
- Becton, Dickinson and Company 5
- QIAGEN GmbH 5
- Applied BioCode, Inc. 3
- Cepheid 2
- Hologic, Inc. 2
- Gen-Probe Prodesse, Inc. 1
- Nanosphere, Inc. 1
- Nanospere,Inc. 1
- Great Basin Scientific, Inc. 1
- Serosep , Ltd. 1
- Genetic Signatures Limited 1
- Luminex Corporation 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253722 | LIAISON PLEX Gastrointestinal Flex AssayPCH · Traditional | Luminex Corporation | 05/19/2026SE |
| K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…PCH · Traditional | QIAGEN GmbH | 03/09/2026SE |
| K251721 | Xpert GI PanelPCH · Traditional | Cepheid | 01/16/2026SE |
| K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…PCH · Traditional | QIAGEN GmbH | 10/22/2025SE |
| K251993 | Panther Fusion GI Expanded Bacterial AssayPCH · Traditional | Hologic, Inc. | 09/25/2025SE |
| K251868 | Panther Fusion GI Bacterial AssayPCH · Traditional | Hologic | 09/25/2025SE |
| K250324 | QIAstat-Dx GI Panel 2 Mini BPCH · Special | QIAGEN GmbH | 02/28/2025SE |
| K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidPCH · Special | Biofire Diagnostics, LLC | 01/16/2025SE |
| K242877 | BioCode Gastrointestinal Pathogen Panel (GPP)PCH · Traditional | Applied BioCode, Inc. | 01/10/2025SE |
| K243813 | QIAstat-Dx GI Panel 2 Mini B&VPCH · Special | QIAGEN GmbH | 01/08/2025SE |
| K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) PanelPCH · Traditional | Biofire Diagnostics, LLC | 11/07/2024SE |
| K220062 | QIAstat-Dx Gastrointestinal Panel 2PCH · Traditional | QIAGEN GmbH | 05/31/2024SE |
| K232672 | EasyScreen Gastrointestinal Parasite Detection KitPCH · Traditional | Genetic Signatures Limited | 05/29/2024SE |
| K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) PanelPCH · Special | Biofire Diagnostics, LLC | 03/16/2023SE |
| K220607 | BD MAX Enteric Viral PanelPCH · Traditional | Becton, Dickinson and Company | 09/21/2022SE |
| K220193 | BD MAX Enteric Parasite PanelPCH · Traditional | Becton, Dickinson and Company | 08/19/2022SE |
| K191161 | xTAG Gastrointestinal Pathogen Panel (GPP)PCH · Special | Luminex Molecular Diagnostics, Inc. | 11/12/2019SE |
| K191160 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)PCH · Special | Luminex Molecular Diagnostics, Inc. | 11/04/2019SE |
| K182703 | EntericBio Dx AssayPCH · Traditional | Serosep , Ltd. | 06/19/2019SE |
| K190585 | Biocode Gastrointestinal Pathogen Panel (GPP)PCH · Traditional | Applied BioCode, Inc. | 06/05/2019SE |
| K183030 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)PCH · Special | Luminex Molecular Diagnostics, Inc. | 11/30/2018SE |
| K183023 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)PCH · Special | Luminex Molecular Diagnostics, Inc. | 11/30/2018SE |
| K181427 | BD MAX Enteric Viral Panel, BD MAX InstrumentPCH · Traditional | Becton, Dickinson and Company | 11/29/2018SE |
| K180041 | BioCode Gastrointestinal Pathogen Panel (GPP)PCH · Traditional | Applied BioCode, Inc. | 09/28/2018SE |
| K170308 | BD MAX Extended Enteric Bacterial Panel, BD MAX SystemPCH · Traditional | Becton, Dickinson and Company | 05/02/2017SE |
| K160459 | FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchPCH · Special | Biofire Diagnostics, LLC | 04/01/2016SE |
| K152955 | Great Basin Shiga Toxin Direct TestPCH · Traditional | Great Basin Scientific, Inc. | 03/22/2016SE |
| K143648 | BD MAX Enteric Parasite Panel, BD MAX InstrumentPCH · Traditional | Becton, Dickinson and Company | 08/25/2015SE |
| K143005 | FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0PCH · Traditional | Biofire Diagnostics, LLC | 02/19/2015SE |
| K142501 | Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert…PCH · Traditional | Cepheid | 11/26/2014SE |
| K140647 | Xtag Gastrointestinal Pathogen Panel(Gpp)/Xtag Data Analysis Software for Gpp(Tdas GPP)PCH · Traditional | Luminex Molecular Diagnostics, Inc. | 10/24/2014SE |
| K142033 | Verigene Enteric Pathogen Nucleic Acid Test (Ep)PCH · Traditional | Nanospere,Inc. | 10/10/2014SE |
| K140377 | Xtag Gastrointestinal Pathogen Panel (Gpp)/Xtag Data Analysis Software for GPP (Tdas GPP)PCH · Traditional | Luminex Molecular Diagnostics, Inc. | 09/16/2014SE |
| K140083 | Verigene Enteric Pathogen Nucleic Acid Test ( Ep)PCH · Traditional | Nanosphere, Inc. | 06/20/2014SE |
| K140407 | Filmarray Gastrointestinal (Gi) PanelPCH · Traditional | Biofire Diagnostics | 05/02/2014SE |
| K121894 | Xtag Gastrointestinal Pathogen Panel(Gpp) Xtag Data Analysis Software for GPP (Tdas GPP)…PCH · Traditional | Luminex Molecular Diagnostics, Inc. | 03/21/2013SE |
| K123274 | Progastro SSCS AssayPCH · Traditional | Gen-Probe Prodesse, Inc. | 01/16/2013SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0793-2026 Class II | Parasite TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0785-2026 Class II | Intestinal Worms TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0765-2026 Class II | Mycotoxin Panel TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0764-2026 Class II | GI Microbiome Profile XLDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0763-2026 Class II | GI Microbiome Profile SmallDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-2514-2024 Class II | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE…Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium. | BioFire Diagnostics, LLC | 05/16/2024Open, Classified |
| Z-1140-2024 Class II | FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test…Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI)… | BioFire Diagnostics, LLC | 01/26/2024Open, Classified |
| Z-0703-2024 Class II | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic…A manufacturing event may contribute to elevated rates of false negative results while using… | BioFire Diagnostics, LLC | 11/27/2023Open, Classified |
| Z-2023-2023 Class II | Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the… | Luminex Corporation | 06/05/2023Open, Classified |
| Z-2588-2023 Class II | FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch…The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers… | BioFire Diagnostics, LLC | 04/25/2023Open, Classified |
| Z-1392-2023 Class II | FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30…Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results. | BioFire Diagnostics, LLC | 03/08/2023Open, Classified |
| Z-1253-2023 Class II | In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116Due to temperature excursions with products (products being stored outside of the required temperature… | BioFire Diagnostics, LLC | 02/01/2023Open, Classified |
| Z-1335-2022 Class II | VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP… | Luminex Corporation | 06/17/2022Open, Classified |
| Z-2451-2021 Class II | Verigene EP Amplification Reagent Kit TestThere is potential for false positive results. | Luminex Corporation | 08/03/2021Open, Classified |
| Z-1488-2021 Class II | VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic…Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used… | Luminex Corporation | 03/18/2021Open, Classified |
| Z-1451-2020 Class II | FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI…Complaints have been received concerning elevated rates of false negative results while using the… | BioFire Diagnostics, LLC | 08/08/2019Terminated |
| Z-2339-2019 Class II | Kit BD Max Enteric Viral Panel EU Catalog # 443985The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | Becton Dickinson & Co. | 07/17/2019Terminated |
| Z-2338-2019 Class II | Kit EXT Enteric Bacterial Panel; Catalog # 443812The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | Becton Dickinson & Co. | 07/17/2019Terminated |
| Z-2330-2019 Class II | Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | Becton Dickinson & Co. | 07/17/2019Terminated |
| Z-2329-2019 Class II | Kit BD Max Enteric Parasite Panel EU; Catalog # 442960The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | Becton Dickinson & Co. | 07/17/2019Terminated |
| Z-1242-2019 Class II | FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF:…Elevated rates of false positive results for Campylobacter and Cryptosporidium have been identified. | BioFire Diagnostics, LLC | 03/06/2019Terminated |
| Z-1767-2019 Class II | xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection…Reports have been received of lower MS2 MFI values when using the panel. | Luminex Molecular Diagnostics | 02/22/2019Open, Classified |
| Z-2952-2018 Class II | Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of…Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nucleic Acid… | Luminex Corporation | 05/08/2018Terminated |
| Z-2685-2014 Class II | The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test…Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures… | Nanosphere, Inc. | 10/10/2013Terminated |