DEN220028 is an FDA 510(k) submission for the Cue COVID-19 Molecular Test. This device is classified as a Over-the-counter Molecular Test To Detect Sars-cov-2 From Clinical Specimens (Class II - Special Controls, product code QWB).
Submitted by Cue Health, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on June 6, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3984. 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..
| 510(k) Number | DEN220028 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | May 02, 2022 |
| Decision Date | June 06, 2023 |
| Days to Decision | 400 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | - |
| Product Code | QWB - Over-the-counter Molecular Test To Detect Sars-cov-2 From Clinical Specimens |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3984 |
| Definition | 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. |