PCH — Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System Class II
Classification Details
- Product Code
- PCH
- Device Class
- Class II
- Regulation Number
- 866.3990
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254032 | qiagen | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx | March 9, 2026 |
| K251721 | cepheid | Xpert GI Panel | January 16, 2026 |
| K252329 | qiagen | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx | October 22, 2025 |
| K251993 | hologic | Panther Fusion GI Expanded Bacterial Assay | September 25, 2025 |
| K251868 | hologic | Panther Fusion GI Bacterial Assay | September 25, 2025 |
| K250324 | qiagen | QIAstat-Dx GI Panel 2 Mini B | February 28, 2025 |
| K243885 | biofire diagnostics | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid | January 16, 2025 |
| K242877 | applied biocode | BioCode Gastrointestinal Pathogen Panel (GPP) | January 10, 2025 |
| K243813 | qiagen | QIAstat-Dx GI Panel 2 Mini B&V | January 8, 2025 |
| K242367 | biofire diagnostics | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | November 7, 2024 |
| K220062 | qiagen | QIAstat-Dx Gastrointestinal Panel 2 | May 31, 2024 |
| K232672 | genetic signatures limited | EasyScreen Gastrointestinal Parasite Detection Kit | May 29, 2024 |
| K230404 | biofire diagnostics | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | March 16, 2023 |
| K220607 | becton, dickinson and | BD MAX Enteric Viral Panel | September 21, 2022 |
| K220193 | becton, dickinson and | BD MAX Enteric Parasite Panel | August 19, 2022 |
| K191161 | luminex molecular diagnostics | xTAG Gastrointestinal Pathogen Panel (GPP) | November 12, 2019 |
| K191160 | luminex molecular diagnostics | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GP | November 4, 2019 |
| K182703 | serosep | EntericBio Dx Assay | June 19, 2019 |
| K190585 | applied biocode | Biocode Gastrointestinal Pathogen Panel (GPP) | June 5, 2019 |
| K183023 | luminex molecular diagnostics | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GP | November 30, 2018 |