FDA Product Code QWR: Simple Point-of-care Device To Detect Sar-cov-2 Nucleic Acid Targets From Clinical Specimens In Near-patient Settings
A Simple Point-of-care Device To Detect Sars-cov-2 Nucleic Acid Targets Directly From Clinical Specimens In Near-patient Settings Is An In Vitro Diagnostic Device For The Direct Detection Of Sars-cov-2 In Clinical Specimens And Is Intended As An Aid In The Diagnosis Of Sars-cov-2 Infections (covid-19). The Device Is Simple To Use And Does Not Involve Sample Manipulation, Transportation Of The Sample To Another Functional Area (e.g., A Central Laboratory Or Other Specialized Area), Or Measurement Of Reagents Or Analytes That Could Be Affected By Conditions Such As Sample Turbidity Or Cell Lysis. The Design And Procedures Of The Device Are Appropriate For Use By Healthcare Professionals In Near-patient Settings Outside A Centralized Laboratory.
Leading manufacturers include Roche Molecular Systems, Inc..
FDA 510(k) Cleared Simple Point-of-care Device To Detect Sar-cov-2 Nucleic Acid Targets From Clinical Specimens In Near-patient Settings Devices (Product Code QWR)
About Product Code QWR - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QWR since 2023, with 3 receiving FDA clearance (average review time: 308 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under QWR have taken an average of 165 days to reach a decision - down from 379 days historically, suggesting improved FDA processing for this classification.
QWR devices are reviewed by the Microbiology panel. Browse all Microbiology devices →