K243463 is an FDA 510(k) clearance for the BIOFIRE FILMARRAY Tropical Fever Panel. This device is classified as a Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness (Class II - Special Controls, product code QMV).
Submitted by Biofire Diagnostics, LLC (Biomerieux) (Salt Lake City, US). The FDA issued a Cleared decision on December 5, 2024, 27 days after receiving the submission on November 8, 2024.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3966. 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..
| 510(k) Number | K243463 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2024 |
| Decision Date | December 05, 2024 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QMV - Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3966 |
| Definition | 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. |