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                Coronavirus (COVID-19) and Medical Devices

Coronavirus (COVID-19) and Medical Devices

                        At-Home OTC COVID-19 Diagnostic Tests
          Counterfeit At-Home OTC COVID-19 Diagnostic Tests
          At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions
          Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers
          COVID-19 Tests Granted Traditional Marketing Authorization by the FDA
          Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19
          Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA)
          Contacts for Medical Devices Related to COVID-19 Home
          Medical Devices
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          Coronavirus (COVID-19) and Medical Devices
          COVID-19 Tests Granted Traditional Marketing Authorization by the FDACoronavirus (COVID-19) and Medical Devices COVID-19 Tests Granted Traditional Marketing Authorization by the FDA
  
  	
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    PrintThe 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
			AuthorizationCepheid
			Xpert® Xpress CoV-2/Flu/RSV plus
			Real-time RT-PCR, Multi-analyte, Multiple Targets
			H, M
			08/17/2023
			510(k):K231481BD Integrated Diagnostic Solutions/Becton, Dickinson & Company
			BD Respiratory Viral Panel for BD MAXTM System 445215; BD Respiratory Viral Panel-SCV2 for BD MAXTM System 445361
			Real-time RT-PCR, Multi-analyte, Multiple Targets
			H, M
			07/31/2023
			510(k):K230956Roche 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):K223591Hologic, Inc.
			Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
			Real-time RT-PCR, Multi-analyte
			H
			05/16/2023
			510(k):K222736Biofire Diagnostics, LLC
			Biofire® Spotfire® Respiratory (R) Panel Mini
			PCR, Multi-analyte, Multiple Targets
			H, M
			04/13/2023
			510(k):K230719DiaSorin Molecular LLC
			Simplexa Covid-19 & Flu A/B Direct
			Real-time RT-PCR, Multi-analyte, Multiple Targets
			H, M
			03/17/2023
			510(k):K220963BioFire Diagnostics
			Biofire Spotfire Respiratory (R) Panel
			Nested multiplex PCR, Multi-analyte, Multiple Targets
			H, M, W
			02/03/2023
			510(k):K213954Biofire Diagnostics, LLC
			BioFire Respiratory Panel 2.1 (RP2.1)
			Nested multiplex PCR, Multi-analyte, Multiple Targets
			H, M
			03/17/2021
			De Novo:DEN200031Cue 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):K232643Roche 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):K231306K213804DiaSorin Molecular LLC
			Simplexa Covid-19 Direct
			Real-time RT-PCR, Multiple Targets
			H, M
			09/13/2022
			510(k):K212147BioFire Defense, LLC
			Biofire Covid-19 Test 2
			RT, Nested multiplex PCR, Multiple Targets
			H, M
			07/25/2022
			510(k):K221460K211079Abbott Diagnostics Scarborough, Inc.
			ID NOW COVID-19 2.0
			RT, Isothermal amplification, Single Target
			H, M, W
			08/10/2023
			510(k):K221925Cepheid
			Xpert® Xpress CoV-2 plus
			Real-time RT-PCR, Multiple Targets
			H, M
			10/13/2023
			510(k):K230440Roche 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

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
			AuthorizationQuidel 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
			K233688ACON 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
			K230828Quidel 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
			AuthorizationOrtho-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:DEN210038Ortho-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)

                                                                                  Content current as of:
      01/09/2024
              
              
Regulated Product(s)
		 Medical DevicesCoronavirus (COVID-19) and Medical Devices

          
                        At-Home OTC COVID-19 Diagnostic Tests
          Counterfeit At-Home OTC COVID-19 Diagnostic Tests
          At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions
          Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers
          COVID-19 Tests Granted Traditional Marketing Authorization by the FDA
          Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19
          Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA)
          Contacts for Medical Devices Related to COVID-19
 
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