Cleared Special

FilmArray Pneumonia Panel

K212727 · Biofire Diagnostics, LLC · Microbiology

Sep 2021

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K212727 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 September 22, 2021, 26 days after receiving the submission on August 27, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3985.

Submission Details

510(k) Number	K212727 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 2021
Decision Date	September 22, 2021
Days to Decision	26 days
Submission Type	Special
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.