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# BioFire Gains Clearance for Respiratory Test
- URL: https://www.fdaweb.com/biofire-gains-clearance-for-respiratory-test/
- Published: 2016-10-12T12:00:00.000Z
- Updated: 2026-09-14T21:39:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137063

FDA has cleared a BioFire Diagnostics 510(k) for the FilmArray Respiratory Panel EZ. The device is intended for use in detecting 11 viral and three bacterial pathogens associated with respiratory infections from a single patient sample. It is designed to run on the FilmArray 2.0 system and provides a simplified user interface and results report, according to the company. Clinical trials that were used to gain 510(k) clearance were supported by the U.S. Department of Defense Chemical and Biological Defense program through the Defense Threat Reduction Agency. Test operators achieved highly accurate results with a 96.8% positive agreement and 99.5% negative agreement with an FDA-cleared molecular comparative method, the company says.