DEN200043 is an FDA 510(k) submission for the FilmArray Global 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 Defense, LLC (Salt Lake City, US). The FDA issued a Not Cleared (DENG) decision on November 20, 2020.
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 | DEN200043 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 26, 2020 |
| Decision Date | November 20, 2020 |
| Days to Decision | 147 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | - |
| 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. |