FDA Product Code QVR: Multiplex Nucleic Acid Detection System For Biothreat Agents
A Multiplex Nucleic Acid Detection System For Biothreat Agents Is A Qualitative In Vitro Diagnostic Test For Detection And Identification Of Nucleic Acids From Biothreat Pathogens In Human Clinical Specimens
Leading manufacturers include Biofire Defense, LLC, T2biosystems, Inc. and Cepheid.
3
Total
3
Cleared
253d
Avg days
2023
Since
Declining activity -
1 submissions in the last 2 years
vs 2 in the prior period
Review times improving: avg
102d
recently vs 328d historically
FDA 510(k) Cleared Multiplex Nucleic Acid Detection System For Biothreat Agents Devices (Product Code QVR)
3 devices
Cleared
Aug 07, 2026
Xpert Hemorrhagic Fever
Cepheid
Microbiology
102d
Cleared
Sep 15, 2023
T2 Biothreat Panel
T2biosystems, Inc.
Microbiology
130d
Cleared
Mar 22, 2023
BioFire Global Fever Special Pathogens Panel
Biofire Defense, LLC
Microbiology
526d
About Product Code QVR - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QVR since 2023, with 3 receiving FDA clearance (average review time: 253 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA 510(k) Review Time - QVR Product Code
Recent submissions under QVR have taken an average of 102 days to reach a decision - down from 328 days historically, suggesting improved FDA processing for this classification.
QVR devices are reviewed by the Microbiology panel. Browse all Microbiology devices →