PCH — Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System Class II
FDA product code PCH covers "Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System", a Class II medical device regulated under 21 CFR 866.3990. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253722 | luminex corporation | LIAISON PLEX Gastrointestinal Flex Assay | May 19, 2026 |
| 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 |