DeviceClearance

Product code QDP— Microbiology

FilmArray Pneumonia Panel

Classification name
Respiratory Panel
Device class
Class 2
Regulation
21 CFR 866.3985
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QDP under 21 CFR 866.3985, via openFDA

Market context for product code QDP

FDA has cleared 2 devices under product code QDP between 2018 and 2021, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QDP

Recent clearances under product code QDP

Data sourced from openFDA. This site is unofficial and independent of the FDA.