QDP — Respiratory Panel Class II

FDA Device Classification

Classification Details

Product Code
QDP
Device Class
Class II
Regulation Number
866.3985
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K212727biofire diagnosticsFilmArray Pneumonia PanelSeptember 22, 2021
K180966biofire diagnosticsFilmArray Pneumonia PanelNovember 9, 2018