510(k) K243463
K243463 is an FDA 510(k) premarket notification submitted by Biofire Diagnostics, LLC (Biomerieux) for the device "BIOFIRE FILMARRAY Tropical Fever Panel". The FDA issued a decision of Substantially Equivalent on December 5, 2024. The device falls under product code QMV (Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness), a Class II device regulated under 21 CFR 866.3966. Biofire Diagnostics, LLC (Biomerieux) has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 2024
- Date Received
- November 8, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
- Device Class
- Class II
- Regulation Number
- 866.3966
- Review Panel
- MI
- Submission Type
A device to detect and identify selected microbial agents that cause acute febrile illness is identified as a in vitro device intended for the detection and identification of microbial agents in human clinical specimens from patients with signs and symptoms of acute febrile illness who are at risk for exposure or who may have been exposed to these agents. It is intended to aid in the diagnosis of acute febrile illness in conjunction with other clinical, epidemiologic, and laboratory data, including patient travel, pathogen endemicity, or other risk factors.