QWB · Class II · 21 CFR 866.3984

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
1–2 of 2
Cleared Nov 28, 2023
Cue COVID-19 Molecular Test
K232643
Cue Health, Inc.
Microbiology · 90d
Not Cleared Jun 06, 2023
Cue COVID-19 Molecular Test
DEN220028
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.

QWB devices are reviewed by the Microbiology panel. Browse all Microbiology devices →