QDP · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3985
Classification
FDA Product Code
QDP
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3985
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.