Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
QID · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.4002
Classification
FDA Product Code
QID
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.4002
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
Y
Implant
N
Third-party review
N
Definition
A device to detect antigens of biothreat microbial agents in human clinical specimens is identified as an in vitro diagnostic device intended for the detection of antigens of microbial agents in specimens collected from patients with signs and symptoms of infection with biothreat microbial agents and who have been exposed to these agents or are suspected or at risk of exposure. Devices to detect antigens of biothreat microbial agents in human clinical specimens may be used for cadaver testing if the cadaver constitutes a source of human-to-human transmission and if testing is performed to prevent human disease.