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FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0

FDA 510(k)

Class II (US FDA 510(k))

510(k) K143005

by BioFire Diagnostics, LLC

Identifiers

510(k) Number
K143005 FDA 510(k)
FDA Product Code
PCH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3990 FDA 510(k)
Regulation Number
866.3990 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The FilmArray Gastrointestinal (GI) Panel is a multiplexed nucleic acid test for the simultaneous qualitative detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair transport medium. It tests for 22 common gastrointestinal pathogens from one stool sample, providing accurate results in about 1 hour.

This device is intended for use with the FilmArray 2.0 System and is a Class 2 device cleared by the FDA under 510(k) K143005. It is a single-use test that requires stool specimens in Cary Blair transport medium and is regulated under product code PCH. The device is manufactured by BioFire Diagnostics, LLC in Salt Lake City, Utah.

Frequently asked questions

What is the FilmArray Gastrointestinal Panel used for?

The FilmArray GI Panel is a multiplexed nucleic acid test designed for the simultaneous qualitative detection and identification of nucleic acids from 22 common gastrointestinal pathogens directly from stool samples in Cary Blair transport medium. It provides accurate results in approximately 1 hour.

How is the FilmArray GI Panel supplied and is it single-use?

The FilmArray GI Panel is a single-use test that requires stool specimens in Cary Blair transport medium. It is designed for one-time use with the FilmArray 2.0 System and should not be reused or repurposed after testing is completed.

What regulatory status does the FilmArray GI Panel have?

The FilmArray GI Panel is a Class 2 device cleared by the FDA under 510(k) K143005. It is regulated under product code PCH and manufactured by BioFire Diagnostics, LLC in Salt Lake City, Utah.

What gastrointestinal pathogens does the FilmArray GI Panel detect?

The panel tests for 22 common gastrointestinal pathogens including bacteria, viruses, and parasites from one stool sample. The specific pathogens are not listed in the provided device data, but the panel is designed to provide comprehensive pathogen detection for gastrointestinal diagnostics.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel, BIOFIRE FILMARRAY 2.0 System, PDF BioFire Gastrointestinal Panel Testing - BioFire Diagnostics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
BioFire Diagnostics, LLC

Sources (1)

  • FDA 510(k) K143005 24 fields · synced Oct 1, 2026