QVF · Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Microbiology · 21 CFR 866.3982 · Class 2
Overview
| Product Code | QVF |
|---|---|
| Device Name | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings |
| Regulation | 21 CFR 866.3982 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
The Sofia 2 SARS Antigen+ FIA is a lateral flow immunofluorescent sandwich assay used with the Sofia 2 instrument for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from symptomatic individuals. It is intended as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when tested at least twice over three days with at least 48 hours between tests.
Classification Rationale
Class II (special controls). The device is a simple qualitative device to directly detect SARS-CoV-2 virus targets in human clinical specimens for settings operating under a certificate of waiver or at home use.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251289 | WELLlife COVID-19 Antigen Test Rx | Guangzhou Wondfo Biotech Co., Ltd. | Oct 22, 2025 | SESE |
| K243872 | BD Veritor System for SARS-CoV-2 | Becton, Dickinson and Company | Jun 16, 2025 | SESE |
| K250273 | BinaxNOW COVID-19 Ag Card | Abbott Diagnostics Scarborough, Inc. | Jun 13, 2025 | SESE |
| K233358 | SCoV-2 Ag Detect Rapid Test | InBios International, Inc. | Aug 23, 2024 | SESE |
| K232377 | Healgen Rapid COVID-19 Antigen Test | Healgen Scientific,, LLC | Apr 19, 2024 | SESE |
| K231187 | Nano-Check COVID-19 Antigen Test | Nano-Ditech Corporation | Jan 23, 2024 | SESE |
| K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set | Quidel Corporation | Dec 13, 2023 | SESE |
| DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set | Quidel Corporation | Mar 8, 2023 | DENG |
Top Applicants
- Quidel Corporation — 2 clearances
- Abbott Diagnostics Scarborough, Inc. — 1 clearance
- Becton, Dickinson and Company — 1 clearance
- Guangzhou Wondfo Biotech Co., Ltd. — 1 clearance
- Healgen Scientific,, LLC — 1 clearance
