BioCode Gastrointestinal Pathogen Panel (GPP)
FDA 510(k) K242877 · Applied BioCode, Inc.
Submission
- Device name
- BioCode Gastrointestinal Pathogen Panel (GPP)
- Applicant
- Applied BioCode, Inc.
Santa Fe Springs, CA, US - Received
- September 23, 2024
- Decision date
- January 10, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PCH – Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3990
- Specialty
- 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…
Other 510(k)s with product code PCH
| 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 |
| 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 |
More from Biofire Diagnostics, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K254139 | BioCode® Respiratory Pathogen Panel (RPP)OCC · Traditional | 05/01/2026SE |
| K192485 | BioCode Respiratory Pathogen Panel (RPP)OCC · Traditional | 12/23/2019SE |
| K190585 | Biocode Gastrointestinal Pathogen Panel (GPP)PCH · Traditional | 06/05/2019SE |
| K180041 | BioCode Gastrointestinal Pathogen Panel (GPP)PCH · Traditional | 09/28/2018SE |
Questions and answers
When was BioCode Gastrointestinal Pathogen Panel (GPP) cleared by the FDA?
BioCode Gastrointestinal Pathogen Panel (GPP) (K242877) received a 510(k) decision of Substantially Equivalent on January 10, 2025, 109 days after the submission was received.
What is the product code of K242877?
The FDA product code is PCH – Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3990.