K232643 is an FDA 510(k) clearance 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 Cleared decision on November 28, 2023, 90 days after receiving the submission on August 30, 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 | K232643 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2023 |
| Decision Date | November 28, 2023 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| 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. |