PRI · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3215
Classification
FDA Product Code
PRI
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3215
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
To aid in decision making on antibiotic therapy, including antibiotic initiation and discontinuation, for inpatients or patients in the Emergency Department, with suspected or confirmed lower respiratory tract infections (LRTI) defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD).