In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2
March 24, 2023 - The FDA has finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). The guidances outline the FDA's general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA's recommendations for:
- Developing a transition implementation plan,
- Submitting a marketing submission, and
- Taking other actions with respect to these devices.
The FDA encourages stakeholders to review the two final guidances, view the webinar, and reach out to the FDA if they have questions or concerns. In particular, for manufacturers planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances.
Additional Resources:
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
- Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023
In Vitro Diagnostic EUAs: Overview and Templates
- Templates and Other Information
- Molecular Diagnostic Tests for SARS-CoV-2
- Other Tests for SARS-CoV-2
- Serology and Other Adaptive Immune Response Tests for SARS-CoV-2
- IVDs for Management of COVID-19 Patients
On This Page:
- Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2
- Revision Concerning Viral Mutations
- Antigen EUA Revisions for Serial (Repeat) Testing
Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2
The table below includes information about authorized SARS-CoV-2 antigen diagnostic tests that have been authorized individually. These emergency use authorizations (EUAs) have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. Test attributes are listed in the "Attributes" column. For example, tests authorized for the screening of asymptomatic individuals without known exposure are listed with "screening" in the attribute column; pooling, multi-analyte, saliva, home collection, and home testing are similarly listed. Tests available without a prescription include the attribute "DTC" (for direct-to-consumer home collection tests) or "OTC" (for over-the-counter at-home tests).
For information on test EUAs that have been revoked see Historical Information about Device Emergency Use Authorizations: In Vitro Diagnostics (IVD).
In addition to COVID-19 tests issued EUAs, there are antigen SARS-CoV-2 diagnostic tests that have been authorized through traditional premarket review pathways.
Tests with "single target" in the attribute column are:
- designed to detect only one antigen target, currently either a section of the spike protein or a section of the nucleocapsid protein;
- more susceptible to changes in performance due to viral mutations, meaning they are more likely to fail to detect new variants.
Tests with "multiple targets" in the attribute column are:
- designed to detect more than one section of the proteins that make up SARS-CoV-2;
- more likely to continue to perform as labeled as new variants emerge.
To see additional authorization documents, such as letters granting EUA amendments or revisions, and a list of other brand names authorized under a specific EUA, select the plus (+) button beside the "Date EUA Issued or Last Updated" for each EUA.
Authorized EUA devices in the table below for SARS-CoV-2 antigen diagnostic tests are assigned the QKP product code. Antigen multi-analyte respiratory panel tests authorized in the table below are assigned the QMN product code.
| Date EUA Issued or Last Updated | Entity | Diagnostic (Most Recent Letter of Authorization) and Date EUA Originally Issued | Attributes | Authorized Setting(s)1 | Authorization Documents2 | Other Documents | Other Brand Name(s) |
|---|---|---|---|---|---|---|---|
| 02/22/2023 | Mologic, Inc. | COVI-Go SARS-CoV-2 Ag Self-Test 02/22/2023 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | None |
| 06/16/2023 | PHASE Scientific International, Ltd. | INDICAID COVID-19 Rapid Antigen At-Home Test 03/16/2022 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 12/11/2023 | SD Biosensor, Inc. | Pilot COVID-19 At-Home Test 12/24/2021 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target, Telehealth Proctor Supervised (optional) | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 08/24/2023 | iHealth Labs, Inc. | iHealth COVID-19 Antigen Rapid Test 11/05/2021 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target, Telehealth Proctor Supervised (optional) | Home, H, M, W | HCP, IFU, IFU (Home Test) | GoToKnow COVID-19 Antigen Rapid Test | |
| 03/15/2023 | ACON Laboratories, Inc | Flowflex COVID-19 Antigen Home Test 10/04/2021 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | On/Go One COVID-19 Antigen Home Test | |
| 11/15/2023 | SEKISUI Diagnostics, LLC. | OSOM COVID-19 Antigen Rapid Test 09/24/2021 | Lateral Flow, Visual Read, Serial Screening, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 02/27/2023 | Quidel Corporation | Sofia SARS Antigen FIA 05/08/2020 | Lateral Flow, Fluorescence, Instrument Read, Serial Screening, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 03/21/2023 | Becton, Dickinson and Company (BD) | BD Veritor System for Rapid Detection of SARS-CoV-2 07/02/2020 | Chromatographic Digital Immunoassay, Instrument Read, Serial Screening, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 08/15/2023 | LumiraDx UK Ltd. | LumiraDx SARS-CoV-2 Ag Test 08/18/2020 | Microfluidic Immunofluorescence Assay, Instrument Read, Serial Screening, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 01/13/2023 | Abbott Diagnostics Scarborough, Inc. | BinaxNOW COVID-19 Ag Card 08/26/2020 | Lateral Flow, Visual Read, Single Target, Serial Screening | H, M, W | HCP, Patients, IFU | None | |
| 08/08/2023 | Quidel Corporation | Sofia 2 Flu + SARS Antigen FIA 10/02/2020 | Lateral Flow, Fluorescence, Instrument Read, Multi-Analyte, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 01/17/2023 | Access Bio, Inc. | CareStart COVID-19 Antigen test 10/08/2020 | Lateral Flow, Visual Read, Serial Screening, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 02/16/2023 | Ellume Limited | Ellume COVID-19 Home Test 12/15/2020 | Lateral Flow, Fluorescence, Instrument Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test), FAQ | None | |
| 04/10/2023 | Abbott Diagnostics Scarborough, Inc. | BinaxNOW COVID-19 Ag Card Home Test 12/16/2020 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Telehealth Proctor Supervised, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 04/04/2023 | Quidel Corporation | QuickVue SARS Antigen Test 12/18/2020 | Lateral Flow, Visual Read, Serial Screening, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 03/01/2023 | Ortho Clinical Diagnostics, Inc. | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack 01/11/2021 | Chemiluminescence Immunoassay, Instrument Read, Single Target | H, M | HCP, Patients, IFU | None | |
| 05/12/2023 | Princeton BioMeditech Corp. | Status COVID-19/Flu A&B 02/04/2021 | Lateral Flow, Visual Read, Multi-analyte, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 03/30/2023 | Quidel Corporation | QuickVue At-Home COVID-19 Test 03/01/2021 | Lateral Flow, Visual Read, Prescription Home Testing, Single Target | Home, H, M, W | HCP, Patients, IFU, IFU (Home Test) | None | |
| 05/12/2023 | Becton, Dickinson and Company (BD) | BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B 03/24/2021 | Chromatographic Digital Immunoassay, Instrument Read, Multi-analyte, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 02/17/2023 | Quidel Corporation | QuickVue At-Home OTC COVID-19 Test 03/31/2021 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) |
| |
| 11/21/2023 | Abbott Diagnostics Scarborough, Inc. | BinaxNOW COVID-19 Antigen Self Test 03/31/2021 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 04/21/2023 | DiaSorin, Inc. | LIAISON SARS-CoV-2 Ag 03/26/2021 | CLIA, Single Target | H, M | HCP, Patients, IFU | None | |
| 05/03/2023 | Qorvo Biotechnologies, LLC. | Omnia SARS-CoV-2 Antigen Test 04/13/2021 | Bulk Acoustic Wave (BAW) Biosensor, Instrument Read, Serial Screening, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 12/23/2022 | InBios International, Inc. | SCoV-2 Ag Detect Rapid Test 05/06/2021 | Lateral Flow, Visual Read, Serial Screening, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 03/29/2023 | Salofa Oy | Sienna-Clarity COVID-19 Antigen Rapid Test Cassette 05/20/2021 | Lateral Flow, Visual Read, Single Target | H, M, W | HCP, Patients, IFU |
| |
| 09/26/2023 | OraSure Technologies, Inc. | InteliSwab COVID-19 Rapid Test Rx 06/04/2021 | Lateral Flow, Visual Read, Prescription Home Testing, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 09/24/2024 | OraSure Technologies, Inc. | InteliSwab COVID-19 Rapid Test 06/04/2021 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening , Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 09/26/2023 | OraSure Technologies, Inc. | InteliSwab COVID-19 Rapid Test Pro 06/04/2021 | Lateral Flow, Visual Read, Serial Screening , Single Target | H, M, W | HCP, Patients, IFU |
| None |
| 02/01/2023 | Ellume Limited | ellume.lab COVID Antigen Test 07/08/2021 | Lateral Flow, Fluorescence, Instrument Read, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 02/21/2023 | GenBody Inc. | GenBody COVID-19 Ag 07/13/2021 | Lateral Flow, Visual Read, Serial Screening, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 06/16/2023 | PHASE Scientific International, Ltd. | INDICAID COVID-19 Rapid Antigen Test 07/28/2021 | Lateral Flow, Visual Read, Serial Screening, Single Target | H, M, W | HCP, Patients, IFU |
| None |
| 03/14/2023 | Access Bio, Inc. | CareStart COVID-19 Antigen Home Test 08/02/2021 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) |
| On/Go COVID-19 Antigen Self-Test |
| 05/18/2023 | QIAGEN GmbH | QIAreach SARS-CoV-2 Antigen 08/05/2021 | Digital Lateral Flow, Fluorescence, Instrument Read, Single Target | H, M | HCP, Patients, IFU | None | |
| 01/06/2023 | InBios International Inc. | SCoV-2 Ag Detect Rapid Self-Test 11/22/2021 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 12/15/2022 | Nano-Ditech Corp. | Nano-Check COVID-19 Antigen Test 12/06/2021 | Lateral Flow, Visual Read, Serial Screening, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 02/17/2023 | Siemens Healthineers | CLINITEST Rapid COVID-19 Antigen Self-Test 12/29/2021 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 02/01/2024 | iHealth Labs, Inc. | iHealth COVID-19 Antigen Rapid Test Pro 01/14/2022 | Lateral Flow, Visual Read, Serial Screening, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 07/08/2024 | Maxim Biomedical, Inc. | MaximBio ClearDetect COVID-19 Antigen Home Test 01/19/2022 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) |
| None |
| 02/24/2023 | Oceanit Foundry LLC | ASSURE-100 Rapid COVID-19 Test 02/28/2022 | Lateral Flow, Visual Read, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 05/03/2023 | Siemens Healthcare Diagnostics, Inc. | Atellica IM SARS-CoV-2 Antigen (CoV2Ag) 03/11/2022 | CLIA, Single Target | H, M | HCP, Patients, IFU | None | |
| 05/03/2023 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) 03/11/2022 | CLIA, Single Target | H, M | HCP, Patients, IFU | None | |
| 09/26/2023 | OSANG LLC | OHC COVID-19 Antigen Self Test 04/06/2022 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | QuickFinder COVID-19 Antigen Self Test | |
| 01/23/2024 | Xiamen Boson Biotech Co., Ltd. | Rapid SARS-CoV-2 Antigen Test Card 04/06/2022 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) |
| None |
| 02/21/2023 | Watmind USA | Speedy Swab Rapid COVID-19 Antigen Self-Test 07/08/2022 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 07/10/2024 | Genabio Diagnostics Inc. | Genabio COVID-19 Rapid Self-Test Kit 07/08/2022 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 06/09/2023 | SEKISUI Diagnostics, LLC. | OSOM COVID-19 Antigen Home Test 11/17/2022 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | None |
| 04/13/2023 | Beijing Hotgen Biotech Co., Ltd. | Hotgen COVID-19 Antigen Home Test 11/17/2022 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 03/16/2023 | CorDX, Inc. | CorDx COVID-19 Ag Test 11/21/2022 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 11/21/2022 | Azure Biotech Inc. | Fastep COVID-19 Antigen Home Test 11/21/2022 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | None |
| 12/06/2022 | ACON Laboratories, Inc. | Flowflex COVID-19 Antigen Rapid Test 12/06/2022 | Lateral Flow, Visual Read, Serial Screening, Single Target | H, M, W | HCP, Patients, IFU | None | None |
| 04/30/2024 | CTK Biotech, Inc. | ImmuView COVID-19 Antigen Home Test 12/20/2022 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 12/22/2022 | Oceanit Foundry LLC | ASSURE-100 Rapid COVID-19 Home Test 12/22/2022 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | None |
| 07/01/2024 | Advin Biotech Inc. | Advin COVID-19 Antigen Test @Home 12/22/2022 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 02/17/2023 | GenBody Inc. | GenBody COVID-19 Ag Home Test 02/17/2023 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | None |
| 09/20/2023 | Biosynchronicity Corporation | C-Sync COVID-19 Antigen Test 03/24/2023 | Lateral Flow, Visual Read, Serial Screening, Multiple Targets | H, M, W | HCP, Patient, IFU | None | |
| 04/14/2023 | Azure Biotech, Inc. | Azure FaStep® COVID-19 Antigen Pen Home Test 04/14/2023 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | None |
| 06/28/2023 | Princeton BioMeditech Corp. | Status COVID-19 Antigen Rapid Test for Home Use 04/24/2023 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 05/12/2023 | Nano-Ditech Corporation | Nano-Check COVID-19 Antigen At-Home Test 05/12/2023 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | None |
| 09/20/2023 | BioTeke USA, LLC | Bio-Self COVID-19 Antigen Home Test 05/22/2023 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 07/17/2023 | Immunostics Inc. | Swab-N-Go Home Test COVID-19 Ag 07/17/2023 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | None |
| 10/23/2024 | Princeton BioMeditech Corp. | ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test 09/08/2023 | Lateral Flow, Visual Read, Multi-analyte, Single Target | H, M, W | HCP, Patient, IFU | None | |
| 09/12/2024 | SD Biosensor, Inc. | STANDARD Q COVID-19 Ag Test 2.0 09/29/2023 | Lateral Flow, Visual Read, Serial Screening, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 09/04/2024 | SEKISUI Diagnostics, LLC | OSOM Flu SARS-CoV-2 Combo Test 02/29/2024 | Lateral Flow, Visual Read, Multi-analyte, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 09/04/2024 | SEKISUI Diagnostics, LLC | OSOM Flu SARS-CoV-2 Combo Home Test 2/29/2024 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Multi-analyte, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 10/18/2024 | OSANG LLC | OHC COVID-19/Flu Antigen Test Pro 03/21/2024 | Lateral Flow, Visual Read, Multi-analyte, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 09/26/2024 | CorDx, Inc. | CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test 03/21/2024 | Lateral Flow, Visual Read, Multi-analyte, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 10/18/2024 | OSANG LLC | QuickFinder COVID-19/Flu Antigen Self Test 04/03/2024 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Multi-analyte, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 09/26/2024 | CorDx, Inc. | CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test 04/05/2024 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Multi-analyte, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 07/02/2024 | Wondfo USA Co., Ltd. | WELLlife COVID-19 / Influenza A&B Test 04/19/2024 | Lateral Flow, Visual Read, Multi-analyte, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 07/02/2024 | Wondfo USA Co., Ltd | WELLlife COVID-19 / Influenza A&B Home Test 04/30/2024 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Multi-analyte, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 10/09/2024 | iHealth Labs, Inc. | iHealth COVID-19/Flu A&B Rapid Test 05/07/2024 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Multi-analyte, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | |
| 05/08/2024 | Watmind USA | Speedy Swab Rapid COVID-19 + Flu A&B Antigen Test 05/08/2024 | Lateral Flow, Visual Read, Multi-analyte, Single Target | H, M, W | HCP, Patients, IFU | None | None |
| 09/12/2024 | iHealth Labs, Inc. | iHealth COVID-19/Flu A&B Rapid Test Pro 05/31/2024 | Lateral Flow, Visual Read, Multi-analyte, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 09/27/2024 | Healgen Scientific, LLC | Healgen COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) 06/10/2024 | Lateral Flow, Visual Read, Multi-analyte, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 05/24/2024 | Watmind USA | Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test 05/24/2024 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Multi-analyte, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | None |
| 11/18/2024 | Nano-Ditech Corporation | Nano-Check Influenza+COVID-19 Dual Test 07/08/2024 | Lateral Flow, Visual Read, Multi-analyte, Single Target | H, M, W | HCP, Patients, IFU | None | |
| 07/23/2024 | ACON Laboratories, Inc. | Flowflex Plus COVID-19 and Flu A/B Home Test 07/23/2024 | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Multi-analyte, Single Target | Home, H, M, W | HCP, IFU, IFU (Home Test) | None | None |
1 Authorized settings 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.
2 Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary.
Revision Concerning Viral Mutations
On September 23, 2021, the FDA revised the EUAs of certain molecular, antigen, and serology tests to establish additional Conditions of Authorization in response to the continued emergence of new variants of SARS-CoV-2. The revision requires test developers to update their authorized labeling and evaluate the impact of SARS-CoV-2 viral mutations on their test’s performance as outlined in the letter. This revision is effective as of September 23, 2021 for all EUAs that are within the scope of the revision. This revision does not apply to EUAs for authorized IL-6 assays or standalone specimen collection devices and does not apply to EUAs that include substantially equivalent viral mutation conditions of authorization.
The FDA has determined that establishing additional conditions is necessary to mitigate the potential risk of false negative results due to either decreased sensitivity or non-reactivity associated with SARS-CoV-2 viral mutations. As set forth in the September 23, 2021 letter, developers of authorized tests that are within the scope of the revision are now required to routinely monitor emerging viral mutations and their potential impact on the performance of the authorized SARS-CoV-2 test(s). If potential impacts are identified, the EUA holder must communicate with the FDA and end users about the potential risk that presence of the mutations may have on test performance. The revision also required the EUA holder to update their authorized labeling consistent with the revision letter and submit the labeling to the FDA within 3 months of September 23, 2021. By taking these steps, the FDA and the test developer can quickly act in response to the potential risks identified and, when applicable, share the findings on SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests.
Viral Mutation Revision Letter – September 23, 2021
Antigen EUA Revisions for Serial (Repeat) Testing
On November 1, 2022, the FDA revised the authorized uses and required updates to product labeling regarding repeat, or serial, testing, for all currently authorized SARS-CoV-2 antigen tests. The revised Letter of Authorization establishes one additional Condition of Authorization and also eliminates one Condition of Authorization that is no longer needed.
This action is in response to available data about the performance of COVID-19 antigen tests showing that repeat testing after a negative COVID-19 antigen test result increases the chance of an accurate result in people with and without symptoms and could help prevent people from unknowingly spreading the SARS-CoV-2 virus to others. The FDA communicated recommendations consistent with this revision in the August 11, 2022, Safety Communication: At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative.
The November 1, 2022 revision requires test developers in the scope of the revision to take certain actions, including submitting a supplemental EUA request to the FDA with updated labeling to reflect the revised authorized uses, as follows:
- Where a test was previously authorized for testing of symptomatic individuals (for example, within the first [number specific to each test] days of symptom onset), the test is now authorized for use at least twice over three days with at least 48 hours between tests.
- Where a test was previously authorized for testing of asymptomatic individuals (for example, individuals without symptoms or other epidemiological reasons to suspect COVID-19), the test is now authorized for use at least three times over five days with at least 48 hours between tests.