510(k) DEN220028
DEN220028 is an FDA 510(k) premarket notification submitted by Cue Health, Inc. for the device "Cue COVID-19 Molecular Test". The FDA issued a decision of De Novo Granted on June 6, 2023. The device falls under product code QWB (Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens), a Class II device regulated under 21 CFR 866.3984. Cue Health, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 6, 2023
- Date Received
- May 2, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
- Device Class
- Class II
- Regulation Number
- 866.3984
- Review Panel
- MI
- Submission Type
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.