PCH · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Microbiology · 21 CFR 866.3990 · Class 2
Overview
| Product Code | PCH |
|---|---|
| Device Name | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System |
| Regulation | 21 CFR 866.3990 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
A gastrointestinal microorganism multiplex nucleic acid-based 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 device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.
Classification Rationale
Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens.” For availability of the guideline document, see § 866.1(e).
Special Controls
*Classification.* Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens.” For availability of the guideline document, see § 866.1(e).
Recent Cleared Devices (20 of 37)
Showing 20 most recent of 37 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH | Mar 9, 2026 | SESE |
| K251721 | Xpert GI Panel | Cepheid | Jan 16, 2026 | SESE |
| K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH | Oct 22, 2025 | SESE |
| K251993 | Panther Fusion GI Expanded Bacterial Assay | Hologic, Inc. | Sep 25, 2025 | SESE |
| K251868 | Panther Fusion GI Bacterial Assay | Hologic | Sep 25, 2025 | SESE |
| K250324 | QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH | Feb 28, 2025 | SESE |
| K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid | Biofire Diagnostics, LLC | Jan 16, 2025 | SESE |
| K242877 | BioCode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | Jan 10, 2025 | SESE |
| K243813 | QIAstat-Dx GI Panel 2 Mini B&V | QIAGEN GmbH | Jan 8, 2025 | SESE |
| K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC | Nov 7, 2024 | SESE |
| K220062 | QIAstat-Dx Gastrointestinal Panel 2 | QIAGEN GmbH | May 31, 2024 | SESE |
| K232672 | EasyScreen Gastrointestinal Parasite Detection Kit | Genetic Signatures Limited | May 29, 2024 | SESE |
| K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC | Mar 16, 2023 | SESE |
| K220607 | BD MAX Enteric Viral Panel | Becton, Dickinson and Company | Sep 21, 2022 | SESE |
| K220193 | BD MAX Enteric Parasite Panel | Becton, Dickinson and Company | Aug 19, 2022 | SESE |
| K191161 | xTAG Gastrointestinal Pathogen Panel (GPP) | Luminex Molecular Diagnostics, Inc. | Nov 12, 2019 | SESE |
| K191160 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Luminex Molecular Diagnostics, Inc. | Nov 4, 2019 | SESE |
| K182703 | EntericBio Dx Assay | Serosep , Ltd. | Jun 19, 2019 | SESE |
| K190585 | Biocode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | Jun 5, 2019 | SESE |
| K183030 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Luminex Molecular Diagnostics, Inc. | Nov 30, 2018 | SESE |
Top Applicants
- Luminex Molecular Diagnostics, Inc. — 8 clearances
- Becton, Dickinson and Company — 5 clearances
- Biofire Diagnostics, LLC — 5 clearances
- QIAGEN GmbH — 5 clearances
- Applied BioCode, Inc. — 3 clearances
