Filmarray Gastrointestinal (Gi) Panel
FDA 510(k) K140407 · Biofire Diagnostics
Submission
- Device name
- Filmarray Gastrointestinal (Gi) Panel
- Applicant
- Biofire Diagnostics
Salt Lake City, UT, US - Received
- February 18, 2014
- Decision date
- May 2, 2014
- 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…
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| 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 |
| K242877 | BioCode Gastrointestinal Pathogen Panel (GPP)PCH · Traditional | Applied BioCode, Inc. | 01/10/2025SE |
| K243813 | QIAstat-Dx GI Panel 2 Mini B&VPCH · Special | QIAGEN GmbH | 01/08/2025SE |
More from QIAGEN GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniQOF · Dual Track | 08/14/2025SE |
| K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidPCH · Special | 01/16/2025SE |
| K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack)…PEN · Special | 12/20/2024SE |
| K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) PanelPCH · Traditional | 11/07/2024SE |
| K241194 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniQOF · Special | 05/30/2024SE |
| K232954 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) PanelQOF · Dual Track | 03/26/2024SE |
| K230719 | BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniQOF · Special | 04/13/2023SE |
| K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) PanelPCH · Special | 03/16/2023SE |
| K213954 | BIOFIRE SPOTFIRE Respiratory (R) PanelQOF · Dual Track | 02/03/2023SE |
| K222601 | FilmArray Pneumonia Panel plusQDS · Special | 10/27/2022SE |
Questions and answers
When was Filmarray Gastrointestinal (Gi) Panel cleared by the FDA?
Filmarray Gastrointestinal (Gi) Panel (K140407) received a 510(k) decision of Substantially Equivalent on May 2, 2014, 73 days after the submission was received.
What is the product code of K140407?
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.