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  1. Coronavirus (COVID-19) and Medical Devices

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 07/27/2023 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 Nested multiplex PCR, Multi-analyte, Multiple Targets H, M, W 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 11/28/2023

De Novo:
DEN220028

510(k):
K232643

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
Cepheid Xpert® Xpress CoV-2 plus Real-time RT-PCR, Multiple Targets H, M 10/13/2023 510(k):
K230440
Roche Molecular Systems, Inc. cobas® SARS-CoV-2 Nucleic acid test for use on the cobas® Liat System Real-time RT-PCR, Multiple Targets H, M, W 12/04/2023 510(k):
K223783
Luminex Corporation LIAISON PLEX Respiratory Flex Assay RT-PCR, Multi-analyte, Multiple Targets H, M 03/01/2024 510(k):
K233410
Luminex Molecular Diagnostics, Inc. NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) RT-PCR, Multi-analyte, Multiple Targets H 03/11/2024 510(k):
K231758
BioFire Diagnostics, LLC BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Nested multiplex PCR, Multi-analyte, Multiple Targets H, M, W 03/26/2024 510(k):
K232954
QIAGEN GmbH QIAstat-Dx Respiratory Panel Plus Real-time RT-PCR, Multi-analyte, Multiple Targets H, M 05/10/2024 510(k): K233100
BioFire Diagnostics, LLC BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini Nested multiplex PCR, Multi-analyte, Multiple Targets H, M, W 05/30/2024 510(k): K230719

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

12/13/2023

De Novo:
DEN220039
K233688
ACON Laboratories, Inc. Flowflex COVID-19 Antigen Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Single Target H, M, W, Home 11/09/2023 K230828
Nano-Ditech Corporation Nano-Check™ COVID-19 Antigen Test Lateral Flow, Visual Read, Single Target H, M 01/23/2024 K231187
Quidel Corporation QuickVue COVID-19 Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Single Target H, M, W, Home 03/22/2024 K231795
Healgen Scientific LLC Healgen Rapid COVID-19 Antigen Test Lateral Flow, Visual Read, Single Target H, M 04/19/2024 K232377
Acon Laboratories, Inc. Flowflex Plus COVID-19 Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Test, Single Target H, M, W, Home 04/19/2024 K233373
IHealth Labs, Inc iHealth COVID-19 Antigen Rapid Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Single Target H, M, W, Home 05/31/2024 K233842

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

 
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