FDA Product Code QWB: Over-the-counter Molecular Test To Detect Sars-cov-2 From Clinical Specimens
An Over-the-counter Molecular Test To Detect Sars-cov-2 Is An In Vitro Diagnostic Device For The Detection Of Sars-cov-2 In Clinical Specimens To Aid In The Diagnosis Of Sars-cov-2 Infection. The Device Is Intended To Be Used By Lay Users And Without Health Care Provider (hcp) Intervention In Home Settings Or Similar Environments.
Leading manufacturers include Cue Health, Inc. and Aptitude Medical Systems, Inc..
3
Total
2
Cleared
265d
Avg days
2023
Since
Declining activity -
1 submissions in the last 2 years
vs 2 in the prior period
Review times increasing: avg
305d
recently vs 245d historically
FDA 510(k) Cleared Over-the-counter Molecular Test To Detect Sars-cov-2 From Clinical Specimens Devices (Product Code QWB)
3 devices
Cleared
Aug 07, 2026
Metrix COVID Test
Aptitude Medical Systems, Inc.
Microbiology
305d
Cleared
Nov 28, 2023
Cue COVID-19 Molecular Test
Cue Health, Inc.
Microbiology
90d
Not Cleared
Jun 06, 2023
Cue COVID-19 Molecular Test
Cue Health, Inc.
Microbiology
400d
About Product Code QWB - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QWB since 2023, with 2 receiving FDA clearance (average review time: 265 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 - QWB Product Code
Recent submissions under QWB have taken an average of 305 days to reach a decision - up from 245 days historically. Manufacturers should account for longer review timelines in current project planning.
QWB devices are reviewed by the Microbiology panel. Browse all Microbiology devices →