COVID-19 Tests Granted Traditional Marketing Authorization by the FDA
The FDA has been working with COVID-19 test developers seeking to pursue marketing authorization through the traditional premarket review pathways, which will allow these tests to continue to be used beyond the time allowed by emergency use authorization. This page lists COVID-19 tests that have received traditional marketing authorization. See the Marketing Your Device page for more information about the traditional premarket review and authorization process.
Background
Initially, COVID-19 tests were only available under emergency use authorization (EUA). Since the Secretary’s 564 declaration related to in vitro diagnostic tests for COVID-19, on February 4, 2020, the FDA has granted EUAs for many COVID-19 tests. Tests with an active EUA can continue to be used as long as they are available and not expired. The FDA has also issued a guidance document with a Transition Plan for Medical Devices Issued EUAs Related to COVID-19 and encourages EUA holders to pursue traditional marketing authorization. Visit the COVID-19 Test EUA page for more information about these EUAs.
The EUA process is different than traditional clearance or approval of these products. The FDA may issue an EUA when the FDA has determined, based on the totality of scientific evidence available to the FDA, that it is reasonable to believe that the product may be effective for the intended use relevant to the emergency and that the known and potential benefits outweigh the known and potential risks of the product. This is different than the traditional device premarket review pathways, where the FDA considers whether there is a reasonable assurance of safety and effectiveness when the device is used as intended.
COVID-19 Tests Granted Traditional Marketing Authorization
CDRH remains committed to expanding access to safe and effective tests through the FDA’s traditional premarket review pathway. The tables below list COVID-19 tests that have been granted marketing authorization by the FDA.
Molecular Diagnostic Tests
| Manufacturer | Device Name | Attributes | Authorized Setting(s)1 | Date of Authorization | Authorization |
|---|---|---|---|---|---|
| Cepheid | Xpert Xpress CoV-2/Flu/RSV plus | Real-time RT-PCR, Multi-analyte, Multiple Targets | H, M | 08/17/2023 | 510(k): K231481 |
| BD Integrated Diagnostic Solutions/Becton, Dickinson & Company | BD Respiratory Viral Panel for BD MAX™ System 445215; BD Respiratory Viral Panel-SCV2 for BD MAX™ System 445361 | Real-time RT-PCR, Multi-analyte, Multiple Targets | H, M | 07/31/2023 | 510(k): K230956 |
| Roche Molecular Systems, Inc. | cobas® SARS-CoV-2 & Influenza A/B For Use On The cobas® Liat System | Real-time RT-PCR, Multi-analyte, Multiple Targets | H, M, W | 7/27/2023 | 510(k): K223591 |
| Hologic, Inc. | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Real-time RT-PCR, Multi-analyte | H | 05/16/2023 | 510(k): K222736 |
| Biofire Diagnostics, LLC | Biofire® Spotfire® Respiratory (R) Panel Mini | PCR, Multi-analyte, Multiple Targets | H, M | 04/13/2023 | 510(k): K230719 |
| DiaSorin Molecular LLC | Simplexa Covid-19 & Flu A/B Direct | Real-time RT-PCR, Multi-analyte, Multiple Targets | H, M | 03/17/2023 | 510(k): K220963 |
| BioFire Diagnostics | Biofire Spotfire Respiratory (R) Panel | Nested multiplex PCR, Multi-analyte, Multiple Targets | H, M, W | 02/03/2023 | 510(k): K213954 |
| Biofire Diagnostics, LLC | BioFire Respiratory Panel 2.1 (RP2.1) | Nested multiplex PCR, Multi-analyte, Multiple Targets | H, M | 03/17/2021 | De Novo: DEN200031 |
| Cue Health Inc. | Cue COVID-19 Molecular Test | Isothermal amplification, Over the Counter (OTC) Home Testing, Screening, Single Target | H, M, W, Home | 06/06/2023 | De Novo: DEN220028 |
| Roche Molecular Systems, Inc. | cobas SARS-CoV-2 Qualitative for Use On The cobas 5800/6800/8800 Systems | Real-time RT-PCR, Multiple Targets | H, M | 06/01/2023 | 510(k): K231306 K213804 |
| DiaSorin Molecular LLC | Simplexa Covid-19 Direct | Real-time RT-PCR, Multiple Targets | H, M | 09/13/2022 | 510(k): K212147 |
| BioFire Defense, LLC | Biofire Covid-19 Test 2 | RT, Nested multiplex PCR, Multiple Targets | H, M | 07/25/2022 | 510(k): K221460 K211079 |
| Abbott Diagnostics Scarborough, Inc. | ID NOW COVID-19 2.0 | RT, Isothermal amplification, Single Target | H, M, W | 08/10/2023 | 510(k): K221925 |
1Authorized setting(s) include the following:
- H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
- M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
- W - Patient care settings operating under a CLIA Certificate of Waiver.
Antigen Diagnostic Tests
| Manufacturer | Device Name | Attributes | Authorized Setting(s)1 | Date of Authorization | Authorization |
|---|---|---|---|---|---|
| Quidel Corporation | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen + FIA Control Swab Set | Lateral Flow, Fluorescence, Instrument Read, Single Target | H, M, W | 03/08/2023 | De Novo: DEN220039 |
1Authorized setting(s) include the following:
- H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
- M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
- W - Patient care settings operating under a CLIA Certificate of Waiver.
Serology Tests
| Manufacturer | Device Name | Attributes | Authorized Setting(s)1 | Date of Authorization | Authorization |
|---|---|---|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator | IgG | H, M | 05/05/2023 | De Novo: DEN210038 |
| Ortho-Clinical Diagnostics, Inc. | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators | Total Antibody | H, M | 05/05/2023 | De Novo: DEN210040 |
1Authorized setting(s) include the following:
- H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
- M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
- W - Patient care settings operating under a CLIA Certificate of Waiver.
These tables will be updated the Monday after a new test is granted marketing authorization and the 510(k) and De Novo Premarket Databases have been updated.
For information on EUAs granted to in vitro diagnostic tests for COVID-19, visit In Vitro Diagnostics EUAs.
Additional Resources
- FAQs: What happens to EUAs when a public health emergency ends? | FDA
- FAQs on Emergency Use Authorizations (EUAs) for Medical Devices Related to COVID-19 | FDA
- Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD)