Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set
FDA 510(k) K233688 · Quidel Corporation
Submission
- Device name
- Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set
- Applicant
- Quidel Corporation
San Diego, CA, US - Received
- November 17, 2023
- Decision date
- December 13, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- 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 (moderate risk)
- Regulation
- 21 CFR 866.3982
- Specialty
- Microbiology
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…
Other 510(k)s with product code QVF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254264 | Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIAQVF · Dual Track | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 09/04/2026SE |
| K253882 | CorDx Tyfast COVID-19 Ag Rapid Test RxQVF · Dual Track | CorDx, Inc. | 06/01/2026SE |
| K251289 | WELLlife COVID-19 Antigen Test RxQVF · Dual Track | Guangzhou Wondfo Biotech Co., Ltd. | 10/22/2025SE |
| K243872 | BD Veritor System for SARS-CoV-2QVF · Dual Track | Becton, Dickinson and Company | 06/16/2025SE |
| K250273 | BinaxNOW COVID-19 Ag CardQVF · Dual Track | Abbott Diagnostics Scarborough, Inc. | 06/13/2025SE |
| K233358 | SCoV-2 Ag Detect Rapid TestQVF · Dual Track | InBios International, Inc. | 08/23/2024SE |
| K232377 | Healgen Rapid COVID-19 Antigen TestQVF · Traditional | Healgen Scientific,, LLC | 04/19/2024SE |
| K231187 | Nano-Check COVID-19 Antigen TestQVF · Traditional | Nano-Ditech Corporation | 01/23/2024SE |
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|---|---|---|
| K231795 | QuickVue COVID-19 TestQYT · Traditional | 03/22/2024SE |
| K232286 | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna InstrumentPGI · Traditional | 12/20/2023SE |
| K230349 | Lyra RSV+hMPV AssayOEM · Special | 03/10/2023SE |
| K230236 | Lyra Influenza A+B AssayOZE · Special | 03/03/2023SE |
| K211342 | Sofia 2 Campylobacter FIALQP · Traditional | 11/23/2021SE |
| K173496 | Sofia 2 Lyme FIA, Sofia Lyme Control SetLSR · Dual Track | 08/30/2018SE |
| K181029 | Solana Bordetella Complete AssayOZZ · Traditional | 07/15/2018SE |
| K173691 | Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation PackLSR · Traditional | 02/28/2018SE |
| K180288 | QuickVue Influenza A+BPSZ · Special | 02/13/2018SE |
| K173250 | Solana GBS AssayNJR · Traditional | 12/21/2017SE |
Questions and answers
When was Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set cleared by the FDA?
Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set (K233688) received a 510(k) decision of Substantially Equivalent on December 13, 2023, 26 days after the submission was received.
What is the product code of K233688?
The FDA product code is QVF – Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings, a Class II (moderate risk) device regulated under 21 CFR 866.3982.