Cleared Traditional

FilmArray Pneumonia Panel

K180966 · Biofire Diagnostics, LLC · Microbiology

Nov 2018

Decision

210d

Days

Class 2

Risk

About This 510(k) Submission

K180966 is an FDA 510(k) clearance for the FilmArray Pneumonia Panel, a Respiratory Panel (Class II — Special Controls, product code QDP), submitted by Biofire Diagnostics, LLC (Salt Lake City, US). The FDA issued a Cleared decision on November 9, 2018, 210 days after receiving the submission on April 13, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3985.

Submission Details

510(k) Number	K180966 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 13, 2018
Decision Date	November 09, 2018
Days to Decision	210 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QDP — Respiratory Panel
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3985
Definition	The Panel Is A Multiplexed Nucleic Acid Test Intended For Use With Systems For The Simultaneous Detection And Identification Of Multiple Respiratory Viral And Bacterial Nucleic Acids, As Well As Select Antimicrobial Resistance Genes, In Sputum-like Specimens (induced Or Expectorated Sputum, Or Endotracheal Aspirates) Or Bronchoalveolar Lavage (bal)-like Specimens (bal Or Mini-bal) Obtained From Individuals Suspected Of Lower Respiratory Tract Infection.