FDA Product Code QMV: Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
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.
Leading manufacturers include Biofire Defense, LLC and Biofire Diagnostics, LLC (Biomerieux).
FDA 510(k) Cleared Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness Devices (Product Code QMV)
About Product Code QMV - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QMV since 2020, with 2 receiving FDA clearance (average review time: 128 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under QMV have taken an average of 27 days to reach a decision - down from 178 days historically, suggesting improved FDA processing for this classification.
QMV devices are reviewed by the Microbiology panel. Browse all Microbiology devices →