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..
2
Total
1
Cleared
245d
Avg days
2023
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Over-the-counter Molecular Test To Detect Sars-cov-2 From Clinical Specimens Devices (Product Code QWB)
2 devices
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
2 total 510(k) submissions under product code QWB since 2023, with 1 receiving FDA clearance (average review time: 245 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.