DEN220039 is an FDA 510(k) submission for the Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set. This device is classified as a Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings (Class II - Special Controls, product code QVF).
Submitted by Quidel Corporation (San Diego, US). The FDA issued a Not Cleared (DENG) decision on March 8, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3982. A Simple Point-of-care Device To Detect Sars-cov-2 Viral Targets Directly From Clinical Specimens In Near-patient Settings Is An In Vitro Diagnostic Device For The Direct Detection Of Sars-cov-2 In Clinical Specimens And Is Intended As An Aid In The Diagnosis Of Sars-cov-2 Infections Covid-19). The Device Is Simple To Use And Does Not Involve Sample Manipulation, Transportation Of The Sample To Another Functional Area (e.g., A Central Laboratory Or Other Specialized Area), Or Measurement Of Reagents Or Analytes That Could Be Affected By Conditions Such As Sample Turbidity Or Cell Lysis. The Design And Procedures Of The Device Are Appropriate For Use By Healthcare Professionals In Near-patient Settings Outside A Centralized Laboratory.
| 510(k) Number | DEN220039 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 16, 2022 |
| Decision Date | March 08, 2023 |
| Days to Decision | 265 days |
| Submission Type | Post-NSE |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | QVF — Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3982 |
| Definition | A Simple Point-of-care Device To Detect Sars-cov-2 Viral Targets Directly From Clinical Specimens In Near-patient Settings Is An In Vitro Diagnostic Device For The Direct Detection Of Sars-cov-2 In Clinical Specimens And Is Intended As An Aid In The Diagnosis Of Sars-cov-2 Infections Covid-19). The Device Is Simple To Use And Does Not Involve Sample Manipulation, Transportation Of The Sample To Another Functional Area (e.g., A Central Laboratory Or Other Specialized Area), Or Measurement Of Reagents Or Analytes That Could Be Affected By Conditions Such As Sample Turbidity Or Cell Lysis. The Design And Procedures Of The Device Are Appropriate For Use By Healthcare Professionals In Near-patient Settings Outside A Centralized Laboratory |