Atlas FDA

PCH

38 FDA 510(k) clearances · Product code

109 daysmedian time to decision
265 days90th percentile
38clearances measured

FDA profile

Official device name
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3990
Medical specialty
Microbiology
FDA definition
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.
Adverse events (MAUDE)
2021: 26 · 2022: 47 · 2023: 62 · 2024: 45 · 2025: 40 · 2026: 31
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
LIAISON PLEX Gastrointestinal Flex Assay (K253722)Luminex Corporation2026-05-19
QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (K254032)QIAGEN GmbH2026-03-09
Xpert GI Panel (K251721)Cepheid2026-01-16
QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (K252329)QIAGEN GmbH2025-10-22
Panther Fusion GI Bacterial Assay (K251868)Hologic2025-09-25
Panther Fusion GI Expanded Bacterial Assay (K251993)Hologic, Inc.2025-09-25
QIAstat-Dx GI Panel 2 Mini B (K250324)QIAGEN GmbH2025-02-28
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid (K243885)Biofire Diagnostics, LLC2025-01-16
BioCode Gastrointestinal Pathogen Panel (GPP) (K242877)Applied BioCode, Inc.2025-01-10
QIAstat-Dx GI Panel 2 Mini B&V (K243813)QIAGEN GmbH2025-01-08
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K242367)Biofire Diagnostics, LLC2024-11-07
QIAstat-Dx Gastrointestinal Panel 2 (K220062)QIAGEN GmbH2024-05-31
EasyScreen Gastrointestinal Parasite Detection Kit (K232672)Genetic Signatures Limited2024-05-29
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K230404)Biofire Diagnostics, LLC2023-03-16
BD MAX Enteric Viral Panel (K220607)Becton, Dickinson and Company2022-09-21
BD MAX Enteric Parasite Panel (K220193)Becton, Dickinson and Company2022-08-19
xTAG Gastrointestinal Pathogen Panel (GPP) (K191161)Luminex Molecular Diagnostics, Inc.2019-11-12
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) (K191160)Luminex Molecular Diagnostics, Inc.2019-11-04
EntericBio Dx Assay (K182703)Serosep , Ltd.2019-06-19
Biocode Gastrointestinal Pathogen Panel (GPP) (K190585)Applied BioCode, Inc.2019-06-05
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) (K183023)Luminex Molecular Diagnostics, Inc.2018-11-30
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) (K183030)Luminex Molecular Diagnostics, Inc.2018-11-30
BD MAX Enteric Viral Panel, BD MAX Instrument (K181427)Becton, Dickinson and Company2018-11-29
BioCode Gastrointestinal Pathogen Panel (GPP) (K180041)Applied BioCode, Inc.2018-09-28
BD MAX Extended Enteric Bacterial Panel, BD MAX System (K170308)Becton, Dickinson and Company2017-05-02
FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch (K160459)Biofire Diagnostics, LLC2016-04-01
Great Basin Shiga Toxin Direct Test (K152955)Great Basin Scientific, Inc.2016-03-22
BD MAX Enteric Parasite Panel, BD MAX Instrument (K143648)Becton, Dickinson and Company2015-08-25
FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 (K143005)Biofire Diagnostics, LLC2015-02-19
Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System (K142501)Cepheid2014-11-26
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP) (K140647)Luminex Molecular Diagnostics, Inc.2014-10-24
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP) (K142033)Nanospere,Inc.2014-10-10
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) (K140377)Luminex Molecular Diagnostics, Inc.2014-09-16
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) (K140083)Nanosphere, Inc.2014-06-20
FILMARRAY GASTROINTESTINAL (GI) PANEL (K140407)Biofire Diagnostics2014-05-02
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX (K121894)Luminex Molecular Diagnostics, Inc.2013-03-21
PROGASTRO SSCS ASSAY (K123274)Gen-Probe Prodesse, Inc.2013-01-16
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS) (DEN130003)Luminex Molecular Diagnostics, Inc.2013-01-14

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Every clearance here is in the API, with alerts when new ones post.