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  1. Emergency Situations (Medical Devices)

Emergency Use Authorizations for Medical Devices

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EUAs for Coronavirus Disease 2019 (COVID-19)

Learn more about medical device Emergency Use Authorizations related to Coronavirus Disease 2019 (COVID-19).


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EUAs for Monkeypox (mpox)

Learn more about medical device Emergency Use Authorizations related to Monkeypox (mpox).



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Zika Virus Emergency Use Authorization

On February 26, 2016, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. § 360bbb-3(b)(1)(C)), the Secretary of Health and Human Services (HHS), Sylvia Burwell, determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves Zika virus. Pursuant to section 564(b)(1) of the Act (21 U.S.C. § 360bbb-3(b)(1)), and on the basis of such determination, the Secretary of HHS then declared that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under 21 U.S.C. § 360bbb-3(a).

Zika Virus Molecular Emergency Use Authorization (EUA) Assays – Performance Evaluation and Key Characteristics:

Since February 26, 2016, when the Secretary of Health and Human Services (HHS) declared that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Zika virus and/or diagnosis of Zika virus infection, FDA has issued an Emergency Use Authorization (EUA) for a number of molecular- and serological-based assays for Zika. In the case of the molecular-based assays, IVD developers as part of their EUA conditions are required to test an FDA Reference Material Panel that includes two different Zika virus strains from the Asian lineage (S1 and S2), using an FDA protocol that included a sensitivity evaluation. Depending on the sample type, the majority of the NAT assays have analytical sensitivities between 500 and 5000 Units/mL (or better) summarized in Table 1, along with some other performance characteristics determined during the EUA evaluation. In addition to sensitivity, the currently authorized tests offer unique characteristics with respect to sample throughput, testing environment, claimed sample types and performance, that are taken into account when considering whether to issue an EUA for an assay, summarized in Table 2. For more information about EUAs in the context of the Zika virus response, please visit FDA's medical countermeasures website.

On August 11, 2017, the FDA issued an Emergency Use Authorization (EUA) for emergency use of The Center for Infection and Immunity, Columbia University's ("Columbia University") CII-ArboViroPlex rRT-PCR assay for the qualitative detection and differentiation of RNA from Zika virus, dengue virus, chikungunya virus, and West Nile virus in serum, and for the qualitative detection of Zika virus RNA in urine (collected alongside a patient-matched serum specimen). The assay is intended for use with specimens collected from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated), by laboratories in the United States (U.S.) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3). Test results are for the identification of Zika, dengue, chikungunya, and West Nile viral RNA. Viral RNA is generally detectable in serum during the acute phase of infection and, according to the updated CDC Guidance for U.S. Laboratories Testing for Zika Virus Infection, up to 14 days in serum and urine, following onset of symptoms, if present. Positive results are indicative of current infection.

On August 2, 2017, the FDA issued an Emergency Use Authorization (EUA) for emergency use of Thermo Fisher Scientific's ("Thermo Fisher") TaqPath Zika Virus Kit (ZIKV) for the qualitative detection of RNA from Zika virus in human serum and urine (collected alongside a patient-matched serum specimen) from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated), by laboratories in the United States (U.S.) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3). Test results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in serum during the acute phase of infection and, according to the updated CDC Guidance for U.S. Laboratories Testing for Zika Virus Infection, up to 14 days in serum and urine (possibly longer in urine), following onset of symptoms, if present. Positive results are indicative of current infection.

On March 20, 2017, the FDA issued an Emergency Use Authorization (EUA) for emergency use of Nanobiosym Diagnostics, Inc.'s ("Nanobiosym") Gene-RADAR Zika Virus Test for the qualitative detection of RNA from Zika virus in human serum from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated), by laboratories in the United States (U.S.) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3). Test results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in serum during the acute phase of infection and, according to the updated CDC Guidance for U.S. Laboratories Testing for Zika Virus Infection, up to 14 days in serum, following onset of symptoms, if present. Positive results are indicative of current infection.

On December 9, 2016, the FDA issued an Emergency Use Authorization (EUA) for emergency use of ELITechGroup Inc. Molecular Diagnostics' ("EGI MDx") Zika ELITe MGB Kit U.S. for the qualitative detection of RNA from Zika virus in human serum and EDTA plasma from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated), by laboratories in the United States (U.S.) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3). Test results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in these specimens during the acute phase of infection and, according to the updated CDC Guidance for U.S. Laboratories Testing for Zika Virus Infection, up to 14 days in serum, following onset of symptoms, if present. In response to FDA's request ELITechGroup Inc. Molecular Diagnostics provided an updated IFU that was posted on October 5, 2021.

On November 21, 2016, the FDA issued an Emergency Use Authorization (EUA) for emergency use of Abbott's RealTime Zika assay for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma and urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated), by laboratories in the United States (U.S.) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3). Test results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in these specimens during the acute phase of infection and, according to the updated CDC Guidance for U.S. Laboratories Testing for Zika Virus Infection, up to 14 days in serum and urine (possibly longer in urine), following onset of symptoms, if present. Positive results are indicative of current infection.

In response to Abbott Molecular Inc.'s request, on January 6, 2017 FDA concurred with the modification to the authorized Abbott RealTime ZIKA assay Kit Fact Sheets to include EDTA whole blood as an authorized specimen type. FDA also concurred with the related updates to the Instructions for Use and the Fact Sheets for the Abbott RealTime ZIKA assay that reflect the addition of EDTA whole blood.

On February 22, 2024, FDA concurred with Abbott Molecular Inc.'s request to update the Instructions for Use in response to FDA’s requested updates and to include some additional minor edits and clarifications.

On September 28, 2016, the FDA issued an Emergency Use Authorization (EUA) for emergency use of ARUP Laboratories' Zika Virus Detection by RT-PCR test for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma and urine (collected alongside a patient-matched serum or EDTA plasma specimen) from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Testing is limited to laboratories designated by ARUP Laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3). Test results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in these specimens during the acute phase of infection and, according to the updated CDC Guidance for U.S. Laboratories Testing for Zika Virus Infection, up to 14 days in serum and urine (possibly longer in urine), following onset of symptoms, if present. In response to FDA's request ARUP Laboratories provided an updated IFU that was posted on October 5, 2021.

On September 23, 2016, the FDA issued an Emergency Use Authorization (EUA) for emergency use of Vela Diagnostics USA, Inc.'s Sentosa SA ZIKV RT-PCR Test for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma, and urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated), by laboratories in the United States (U.S.) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3). Test results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in these specimens during the acute phase of infection and, according to the updated CDC Guidance for U.S. Laboratories Testing for Zika Virus Infection, up to 14 days in serum and urine (possibly longer in urine), following onset of symptoms, if present. Positive results are indicative of current infection.

On July 29, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the Siemens Healthcare Diagnostics Inc.'s VERSANT Zika RNA 1.0 Assay (kPCR) Kit for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma, and urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated), by laboratories in the United States (U.S.) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories.

In response to Siemens Healthcare Diagnostics Inc.'s request, on December 19, 2016 FDA concurred with the modification to the authorized VERSANT Zika RNA 1.0 Assay (kPCR) Kit Fact Sheets to combine the Fact Sheet for Patients and the Fact Sheet for Pregnant Women into one Fact Sheet for Patients and to include updated language to align with the latest CDC Zika Laboratory Guidance, implemented in November 2016. The Instructions for Use remains unchanged by this request.

On July 19, 2016 the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Viracor-IBT Laboratories, Inc.'s ("Viracor-IBT") Zika Virus Real-time RT-PCR test for the qualitative detection of RNA from Zika virus in human serum, plasma or urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated). Testing is limited to Viracor-IBT's laboratory in Lee's Summit, MO, or other laboratories designated by Viracor-IBT that are also certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

In response to Viracor Eurofins' request, on February 28, 2017 FDA concurred with the modifications to the authorized Instructions for Use labeling and Fact Sheets for the Zika Virus Real-time RT-PCR Test to update the company name and also combine the Fact Sheet for Patients and the Fact Sheet for Pregnant Women into one Fact Sheet for Patients and to include updated language to align in response to FDA's request Viracor Eurofins provided an updated IFU that was posted on October 5, 2021.

On June 17, 2016 the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Hologic, Inc.'s Aptima Zika Virus assay for the qualitative detection of RNA from Zika virus in human serum and plasma specimens from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated), by laboratories in the United States (U.S.) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests, or by similarly qualified non-U.S. laboratories.

In response to Hologic Inc.'s request, on September 7, 2016 FDA concurred with the revision to add processed urine (collected alongside a patient-matched serum or plasma specimen) as an authorized specimen under the emergency use authorization of the Aptima Zika Virus Assay issued on June 17, 2016. The Instructions for Use and Fact Sheets also have been updated to incorporate these revisions, and the Pregnant Women and Patient Fact Sheets were combined into one Patient Fact Sheet.

In response to Hologic, Inc.'s request, on April 12, 2017 FDA concurred with the modifications to the authorized Instructions for Use labeling for the Aptima Zika Virus assay to (1) extend the stability of processed urine specimens, (2) clarify storage and stability of serum and plasma specimens, and (3) improve the overall clarity and accuracy of the document. FDA also concurred with minor updates to the authorized Aptima Zika Virus assay Fact Sheets that were requested by FDA.

In response to Hologic, Inc.'s request, on March 8, 2018 FDA concurred with the request to add processed whole blood K2EDTA (collected alongside a patient-matched serum or plasma specimen) as an authorized specimen under the emergency use authorization of the Aptima Zika Virus Assay issued on June 17, 2016. FDA also concurred with the related updates to the Instructions for Use and the Fact Sheets for the Aptima Zika Virus assay that reflect the addition of processed whole blood K2EDTA (collected alongside a patient-matched serum or plasma specimen).

On August 24, 2023, FDA concurred with Hologic, Inc.’s request to update the Instructions for Use in response to FDA’s requested updates and to include some additional minor edits and clarifications.

On May 13, 2016 the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of altona Diagnostics RealStar Zika Virus RT-PCR Kit U.S. for the qualitative detection of RNA from Zika virus in serum or urine (collected alongside a patient-matched serum specimen) from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika virus transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated), by laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests, or by similarly qualified non-U.S. laboratories.

In response to altona Diagnostics GmbH's request, on October 31, 2016 FDA concurred with the revision to add the MagNA Pure 96 Instrument (Roche) and the NucliSENS easyMAG Instrument (bioMérieux) and their respective extraction chemistry/reagents as authorized extraction methods under the emergency use authorization of the RealStar Zika Virus RT-PCR Kit U.S. issued on May 13, 2016. The Instructions for Use and Fact Sheets have been updated to incorporate these revisions, and the Pregnant Women and Patient Fact Sheets were combined into one Patient Fact Sheet.

In response to altona Diagnostics GmbH's request, on March 6, 2017 FDA concurred with the following revisions to the emergency use authorization of the RealStar Zika Virus RT-PCR Kit U.S. issued on May 13, 2016: (1) update the Instructions for Use and Fact Sheets to include EDTA plasma as an authorized clinical specimen; and (2) update the Instructions for Use to include results of the FDA Reference Material testing with the RealStar Zika Virus RT-PCR Kit U.S.

On April 28, 2016 the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Focus Diagnostics, Inc.'s, Zika Virus RNA Qualitative Real-Time RT-PCR test for the qualitative detection of RNA from Zika virus in human serum specimens from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated), by qualified laboratories designated by Focus Diagnostics, Inc., and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to perform high complexity tests.

In response to Focus Diagnostics, Inc.'s request to amend this EUA, on October 7, 2016 FDA reissued the April 28, 2016, EUA in its entirety with the Focus Diagnostics, Inc.'s requested amendments incorporated. The amendments to the Zika Virus RNA Qualitative Real-Time RT-PCR Test: (1) allow use of a commercially sourced inactivated Zika virus as a positive control material in addition to the Zika virus strain FLR (live virus); (2) allow the addition of urine (when collected alongside a patient-matched serum specimen) as an authorized specimen type; (3) update the Instructions for Use with the results of the FDA Reference Material sensitivity studies; (4) combine the Pregnant Women and Patient Fact Sheets into one Patient Fact Sheet; and (5) enable, as described in Section IV (Conditions of Authorization) of this letter, certain changes or additions to be made by Focus Diagnostics, Inc. in consultation with, and with concurrence of, the Division of Microbiology Devices (DMD)/Office of In Vitro Diagnostics and Radiological Health (OIR)/Center for Devices and Radiological Health (CDRH). The authorized Instructions for Use and Fact Sheets also have been updated to incorporate these amendments, where applicable.

In response to Quest Diagnostics Infectious Disease, Inc. request, on April 11, 2017 FDA concurred with the modifications to the authorized Instructions for Use labeling and Fact Sheets for the Zika Virus RNA Qualitative Real-Time RT-PCR test to update the company name.

On February 26, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention's (CDC) Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for the presumptive detection of Zika virus-specific IgM in human sera or cerebrospinal fluid (CSF) that is submitted alongside a patient-matched serum specimen from individuals meeting CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., recent history of travel to geographic regions during a period of active Zika virus transmissions at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated as part of a public health response), by qualified laboratories designated by CDC and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3). Where there are positive or equivocal results from the Zika MAC-ELISA, confirmation of the presence of anti-Zika IgM antibodies requires additional testing by CDC, or by authorized laboratories in consultation with CDC, using the CDC-issued algorithm.

In response to CDC's request to amend this EUA, on June 29, 2016 FDA reissued the February 26, 2016, EUA in its entirety with the CDC-requested amendments incorporated. The amendments: (1) update the language for the CDC Zika virus clinical and epidemiological criteria; (2) update the language related to additional testing of positive or equivocal test results using the CDC algorithm; (3) allow use of Zika COS-1 Recombinant Antigen (CDC catalog #AV0005) as Zika Viral Antigen in addition to Lyophilized Zika Vero E6 Tissue Culture Antigen (CDC catalog #AV002 or AV003); and (4) as described in Section IV. Conditions of Authorization of this letter, enable certain changes or additions to be made by CDC in consultation with, and with concurrence by, FDA's Division of Microbiology Devices (DMD)/Office of In Vitro Diagnostics and Radiological Health (OIR)/Center for Devices and Radiological Health (CDRH). The Instructions for Use and Fact Sheets also have been updated to incorporate these amendments, where applicable.

In response to CDC's request on November 15, 2016, FDA concurred with the modification to the CDC algorithm for results confirmation of the Zika MAC-ELISA as outlined in the updated CDC Guidance for U.S. Laboratories Testing for Zika Virus Infection (revised). The Instructions for Use and Fact Sheets remain unchanged by this request.

In response to CDC's request, on December 6, 2016 FDA concurred with the modification to the authorized Zika MAC-ELISA Fact Sheets to combine the Fact Sheet for Patients and the Fact Sheet for Pregnant Women into one Fact Sheet for Patients and to include updated language to align with the latest CDC Zika Laboratory Guidance, implemented in November 2016. The Instructions for Use remains unchanged by this request.

In response to CDC's request, on May 3, 2017 FDA concurred with the modifications to the authorized Instructions for Use labeling for the CDC Zika MAC-ELISA to (1) add the DynexTechnologies, Inc.'s Agility and DSX systems as acceptable automated instruments for use with the Zika MAC-ELISA, (2) add language recommending an additional negative human serum control be run once daily, (3) include a limitation concerning the use of the Hennessey detecting antibody conjugate 6B6C-1 in conjunction with the Vero E6 antigen when testing infant serum, and (4) update contact information. FDA also concurred with minor updates to the authorized Zika MAC-ELISA Fact Sheet for Healthcare Providers.

In response to CDC's request, on July 31, 2017 FDA concurred with the interim update to the Instructions for Use labeling for the CDC Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) to provide additional acceptance criteria designed to enhance the precision and accuracy of the assay across all testing laboratories. The CDC communication to Zika Testing Laboratories has been appended to the front of the currently posted Zika MAC-ELISA IFU document.

In response to CDC's request, on April 16, 2018 FDA concurred with the modifications to the authorized Instructions for Use labeling for the CDC Zika MAC-ELISA to (1) include a standardized negative control serum and calibration control serum reagent set as one of the materials provided by CDC, (2) include use the Flavivirus group-specific conjugate MAB 6B6C-1/HRP with the Zika MAC-ELISA in CDC laboratories only, (3) integrate the previously granted test result acceptance criteria designed to enhance the precision and accuracy of the assay across all testing laboratories, (4) remove the Hennessey conjugate as a recommended detecting antibody conjugate, and (5) update the specimen handling and safety precautions.

In response to FDA's request CDC provided an updated IFU that was posted on October 5, 2021.

In response to CDC's request to amend this EUA, on September 27, 2023, FDA reissued the June 29, 2016, EUA in its entirety with the CDC-requested amendments incorporated. The amendments: (1) updates to the intended use to reflect updated recommendations to the CDC-issued testing algorithm, including that equivocal or presumptive positive specimens “may require additional testing” rather than “require additional testing”, and updated scientific knowledge of the duration of Zika IgM antibodies in individuals exposed to the virus, (2) remove use of the Zika Vero E6 Tissue Culture Antigen and Normal Vero E6 Antigen reagents for use with your product, (3) include use of “Human sera positive for Zika IgM antibodies” as an acceptable Zika IgM antibody positive control for use with your product, (4) remove the requirement for QC validation calculation steps, (5) update the number of outer rim wells used to blank the plate, (6) remove the requirement for repeat testing for inconclusive results prior to follow-up PRNT testing, (7) updates to the flavivirus cross-reactivity section to include results of additional testing and update the current limitation with respect for flavivirus cross-reactivity, (8) updates to the clinical performance section based on additional data, and (9) updating the Fact Sheet for Healthcare Providers, Fact Sheet for Patients, and the Letter of Authorization to reflect the updates made and for consistency with language used in more recent authorizations.

On March 17, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention's (CDC) Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR) for the qualitative detection and differentiation of RNA from Zika virus, dengue virus, and chikungunya virus in human sera or cerebrospinal fluid (collected alongside a patient-matched serum specimen), and for the qualitative detection of Zika virus RNA in urine and amniotic fluid (each collected alongside a patient-matched serum specimen). The assay is intended for use with specimens collected from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated as part of a public health investigation). Testing is performed by qualified laboratories designated by CDC and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3).

In response to CDC's request, on September 21, 2016, FDA concurred with the following revisions to the emergency use authorization of the Trioplex Real-time RT-PCR Assay issued on March 17, 2016: (1) include a large volume (up to 1.0 mL) nucleic acids extraction option for use with the authorized automated MagNA Pure 96 instrument for authorized specimens; (2) add two automated extraction instruments, the MagNA Pure Compact and the BioMerieux easyMAG instruments, for nucleic acid extraction from the appropriate clinical specimen types using the appropriate small and/or large volume extraction options per specimen type; and (3) add whole blood (EDTA) as an authorized specimen for the qualitative detection and differentiation of RNA from Zika virus, Dengue virus, and chikungunya virus. The Instructions for Use and Fact Sheets also have been updated to incorporate these revisions, and the Pregnant Women Fact Sheet and Patient Fact Sheet were combined into one Patient Fact Sheet.

In response to CDC's request, on January 12, 2017, FDA concurred with the modifications to the authorized Instructions for Use labeling for the CDC Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR) to (1) clarify the volume of lysis buffer preferred for use with the authorized easyMAG extraction instrument, (2) add a singleplex reaction option for the Trioplex rRT-PCR, and (3) clarify the expected positive control values/ranges in the Trioplex Positive Control package insert.

In response to CDC's request, on March 1, 2017 FDA concurred with the modifications to the authorized Instructions for Use labeling for the CDC Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR) to include the results of the FDA Reference Material testing with the Trioplex rRT-PCR and to correct some typographical errors. FDA also concurred with some minor modifications to the authorized Trioplex rRT-PCR Fact Sheets.

In response to CDC's request, on April 6, 2017 FDA concurred with the modifications to the authorized Instructions for Use labeling for the CDC Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR) to (1) add the QuantStudio Dx Real-Time PCR instrument for use with the Trioplex rRT-PCR, (2) correct some typographical errors, and (3) make some revisions to improve clarity.

In response to CDC's request, on February 26, 2021 FDA concurred with the modifications to the authorized Instructions for Use (IFU), Package Insert, and product labels to; (1) update the shelf-life stability for the CDC Trioplex rRT-PCR Primer and Probe Set and the CDC Trioplex Real-time RT-PCR Positive Control Set reagents and (2) update the contact information.


2014 Ebola Virus Emergency Use Authorizations

On September 22, 2006, then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, determined, pursuant to section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. § 247d-6b), that the Ebola virus presents a material threat against the United States population sufficient to affect national security. Pursuant to section 564(b)(1) of the Act (21 U.S.C. § 360bbb-3(b)(1)), and on the basis of such determination, the Secretary of HHS declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus, subject to the terms of any authorization issued under 21 U.S.C. § 360bbb-3(a)

On August 5, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the U.S. Department of Defense (DoD) EZ1 Real-time RT-PCR Assay for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in Trizol-inactivated whole blood or Trizol-inactivated plasma specimens from individuals in affected areas with signs and symptoms of Ebola virus infection or who are at risk for exposure or may have been exposed to the Ebola Zaire virus (detected in the West Africa outbreak in 2014) in conjunction with epidemiological risk factors. This authorization is limited to the use of the authorized EZ1 rRT-PCR Assay on specified instruments by laboratories designated by DoD. In response to DoD's request to amend this EUA, on October 10, 2014 FDA reissued the August 5, 2014, EUA in its entirety with the DoD-requested amendments incorporated. The amendments authorize the use of the DoD EZ1 rRT-PCR Assay in whole blood or plasma specimens, in addition to Trizol-inactivated whole blood or Trizol-inactivated plasma specimens, from individuals in affected areas with signs and symptoms of Ebola virus infection or who are at risk for exposure or may have been exposed to the Ebola Zaire virus (detected in the West Africa outbreak in 2014) in conjunction with epidemiological risk factors, by laboratories designated by DoD. The amendments also include revisions to the Instructions for Use, product insert, and Fact Sheets for Health Care Providers and Patients to address the addition of whole blood and plasma specimens.

On October 10, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the Centers for Disease Control and Prevention (CDC) Ebola Virus NP Real-time RT-PCR Assay for the in vitro qualitative detection of Ebola Zaire virus in whole blood, serum, and plasma specimens from individuals in affected areas with signs and symptoms of Ebola virus infection and/or epidemiological risk factors. The CDC Ebola Virus NP Real-time RT-PCR Assay can also be used with urine specimens when tested in conjunction with a patient-matched whole blood, serum, or plasma specimen. This authorization was limited to the use of the authorized CDC Ebola Virus NP Real-time RT-PCR Assay on the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR Instrument by qualified laboratories designated by CDC. In response to CDC's request to amend this EUA, on March 2, 2015, FDA reissued the October 10, 2014, EUA in its entirety with the CDC requested amendment incorporated. The amendments authorize use of the CDC Ebola Virus NP Real-time RT-PCR Assay with the BioRad CFX96 Touch Real-Time PCR instrument, in addition to the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR instrument. The Instructions for Use and Fact Sheet for Health Care Providers have also been updated to incorporate this amendment. The amendments also allow the future use of "other authorized instruments", of "other extraction methods" and of "other authorized specimen types" when requested by CDC and concurred with by FDA.

In response to CDC's request, on October 8, 2019 FDA concurred with the modifications to the Healthcare Provider and Patient Fact Sheets for the CDC Ebola Virus NP Real-time RT-PCR Assay to reflect changes to the CDC testing algorithm and updated epidemiological information concerning Ebola virus disease (EBV).

On October 10, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the Centers for Disease Control and Prevention (CDC) Ebola Virus VP40 Real-time RT-PCR Assay for the in vitro qualitative detection of Ebola Zaire virus in whole blood, serum, and plasma specimens from individuals in affected areas with signs and symptoms of Ebola virus infection and/or epidemiological risk factors. The CDC Ebola Virus VP40 Real-time RT-PCR Assay can also be used with urine specimens when tested in conjunction with a patient-matched whole blood, serum, or plasma specimen. This authorization was limited to the use of the authorized CDC Ebola Virus VP40 Real-time RT-PCR Assay on the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR Instrument by qualified laboratories designated by CDC. In response to CDC's request to amend this EUA, on March 2, 2015, FDA reissued the October 10, 2014, EUA in its entirety with the CDC requested amendment incorporated. The amendments authorize use of the CDC Ebola Virus VP40 Real-time RT-PCR Assay with the BioRad CFX96 Touch Real-Time PCR instrument, in addition to the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR instrument. The Instructions for Use and Fact Sheet for Health Care Providers have also been updated to incorporate this amendment. The amendments also allow the future use of "other authorized instruments", of "other extraction methods" and "other authorized specimen types" when requested by CDC and concurred with by FDA.

In response to CDC's request, on October 8, 2019 FDA concurred with the modifications to the Healthcare Provider and Patient Fact Sheets for the CDC Ebola Virus VP40 Real-time RT-PCR Assay to reflect changes to the CDC testing algorithm and updated epidemiological information concerning Ebola virus disease (EBV).

On October 25, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the BioFire Defense LLC FilmArray Biothreat-E test for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in whole blood specimens from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors.  The FilmArray Biothreat-E test can also be used with urine specimens when tested in conjunction with a patient-matched whole blood specimen. This authorization is limited to the use of the authorized FilmArray Biothreat-E test on only the FilmArray Instrument by CLIA Moderate and High Complexity Laboratories.

In response to BioFire Defense LLC's request, on November 12, 2019 FDA concurred with modifications to the authorized Instructions for Use of the FilmArray Biothreat-E test to include new data on analytical exclusivity wet-testing and associated limitations. FDA also concurred with the modifications to the (1) Instructions for Use, including wording in the intended use, to improve the overall clarity and accuracy of the document, and (2) Healthcare Provider and Patient Fact Sheets, that were requested by FDA.

On November 10, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the RealStar Ebolavirus RT-PCR Kit 1.0 for the presumptive detection of RNA from Ebolaviruses [such as Zaire ebolavirus (including the Zaire ebolavirus strain detected in the West Africa outbreak 2014), Sudan ebolavirus, Tai Forest ebolavirus, Bundibugyo ebolavirus, and Reston ebolavirus] in EDTA plasma from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors. This authorization is limited to the use of the authorized RealStar Ebolavirus RT-PCR Kit 1.0 on only specified instruments by CLIA high complexity laboratories. The RealStar Ebolavirus RT-PCR Kit 1.0 does not distinguish between the different Ebola virus species or strains. In response to altona Diagnostics GmbH's request to amend this EUA, on November 26, 2014 FDA reissued the November 10, 2014, EUA in its entirety with the altona Diagnostics GmbH-requested amendments incorporated. The amendments allow, in addition to altona Diagnostics GmbH, distributors that are authorized by altona Diagnostics GmbH to distribute the RealStar Ebolavirus RT-PCR Kit 1.0 with certain conditions applicable to such authorized distributor(s). Because this assay may be distributed outside the U.S., the amendments also allow the use of this assay under this EUA, with certain conditions, at non-U.S. laboratories that are similarly qualified as CLIA High Complexity Laboratories. The Instructions for Use and Fact Sheet for Health Care Providers have also been updated to incorporate these amendments.

On December 23, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize use of the LightMix Ebola Zaire rRT-PCR Test for the presumptive detection of the Ebola Zaire virus in a preparation of whole blood from individuals with signs and symptoms of Ebola disease. The Test runs on only specified instruments by CLIA high complexity laboratories or similarly qualified non-U.S. laboratories.

On March 23, 2015, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the Xpert Ebola Assay for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) on the GeneXpert Instrument Systems in EDTA venous whole blood specimens from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors. The Xpert Ebola Assay should be performed in CLIA Moderate and High Complexity Laboratories or in similarly qualified non-U.S. laboratories, by clinical laboratory personnel who have received specific training on the use of the Xpert Ebola Assay on GeneXpert Instrument Systems. In response to Cepheid's request, on June 13, 2023, FDA concurred with modifications to the Instructions for Use to; (1) include an additional limitation, (2) update the analytical reactivity section, (3) update some of the background information, and (4) add some clarification and formatting changes. In addition, FDA requested updates to the (1) Instructions for Use, including wording in the intended use, to improve the overall clarity and accuracy of the document, and (2) Healthcare Provider and Patient Fact Sheets.

On November 9, 2018, the FDA issued an Emergency Use Authorization (EUA) for emergency use of Chembio Diagnostic Systems, Inc.'s DPP Ebola Antigen System for the presumptive detection of Ebola virus (species Zaire ebolavirus and hereafter referred to as Ebola virus) in human capillary ("fingerstick") whole blood, EDTA venous whole blood, and EDTA plasma from individuals with signs and symptoms of Ebola virus disease (EVD) in conjunction with epidemiological risk factors (including geographic locations with high prevalence of EVD), by laboratories and facilities adequately equipped, trained and capable of such testing (including treatment centers and public health clinics), pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3). The DPP Ebola Antigen System is intended for circumstances when use of a rapid Ebola virus test is determined to be more appropriate than use of an Ebola virus nucleic acid test, which has been demonstrated to be more sensitive in detecting the Ebola virus. The DPP Ebola Antigen System is not intended for use for general EVD screening, such as airport screening or contact tracing of individuals without signs and symptoms of EVD.

In response to Chembio Diagnostic Systems, Inc.'s request, on April 2, 2019 FDA concurred with the modifications to the authorized Instructions for Use labeling for the DPP Ebola Antigen System to update 1) the cross-reactivity performance for Plasmodium malariae and Streptococcus pneumoniae in whole blood, and 2) the endogenous interference data for Rheumatoid Factor, Glucose, unconjugated bilirubin, cholesterol and HAMA.


2013 Coronavirus Emergency Use Authorization (Potential Emergency)

On May 29, 2013 Secretary Kathleen Sebelius determined that Middle East respiratory syndrome coronavirus (MERS-CoV) poses a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad. On the basis of this determination the Secretary declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the Middle East respiratory syndrome coronavirus (MERS-CoV).

On June 5, 2013, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the CDC Novel Coronavirus 2012 Real-time RT-PCR Assay for the presumptive detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in patients with signs and symptoms of MERS-CoV infection in conjunction with clinical and epidemiological risk factors by qualified laboratories. In response to CDC's request to amend this EUA, on June 10, 2014 FDA reissued the June 5, 2013, EUA in its entirety with the CDC-requested amendments incorporated. The amendments authorize the expanded use of the CDC assay to include testing persons who may not be exhibiting signs and symptoms associated with MERS-CoV infection, but who meet certain epidemiological risk factors (e.g., contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-CoV cases were detected, or other epidemiologic links for which MERS-CoV testing may be indicated as part of a public health investigation). The EUA amendments also include a new fact sheet for contacts of MERS cases and revisions/updates to the instructions for use and fact sheets for patients and health care professionals. This device will be distributed by CDC to qualified laboratories. In response to CDC's request to amend this EUA, on February 17, 2023 FDA concurred with the modifications to the authorized Instructions for Use labeling for the CDC Novel Coronavirus 2012 Real-time RT-PCR Assay to clarify the Specimen Handling and Storage Section.

In response to CDC's request to amend this EUA, on June 24, 2024 FDA reissued the June 10, 2014, EUA in its entirety with the CDC-requested amendments incorporated. The amendments included: (1) updates to the intended use to remove stool and serum as specimen claims, (2) updates to the intended use for consistency with language used in more recent authorizations, (3) removing use of one of the primer/probes sets used as part of the product and updating the testing algorithm accordingly, (4) removal of the the MagNA Pure Compact as an authorized extraction method, (5) addition of the QIAGEN QIAamp MinElute Virus Spin (manual) kit and QIAGEN DSP virus kit used with QIAGEN EZ1 Advanced XL platform (automated) as authorized extraction method options, (6) addition of the TaqPath 1-step multiplex master mix as a master mix option, (7) updating the inclusivity, cross reactivity and clinical performance data, (8) including the addition of a Human Specimen Control (HSC) as an external extraction control, (9) combining the Patient and Contacts Fact Sheets into one Fact Sheet for Patients and Contacts, and (10) updating the authorized Fact Sheets and the Letter of Authorization to reflect the updates made and for consistency with language used in more recent authorizations.

On July 17, 2015, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the RealStar MERS-CoV RT-PCR Kit U.S. for the in vitro qualitative detection of RNA from the Middle East Respiratory Syndrome Coronavirus (MERS-CoV), formerly known as Novel Coronavirus 2012 or NCV-2012, in lower respiratory specimens (tracheal aspirate/tracheal secretions) from individuals with signs and symptoms of infection with MERS-CoV in conjunction with epidemiological risk factors for the presumptive detection of MERS-CoV, by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and similarly qualified non-U.S. laboratories. In response to altona Diagnostics GmbH's request to amend this EUA, on February 12, 2016 FDA reissued the July 17, 2015 EUA in its entirety with the altona Diagnostics GmbH-requested amendments incorporated. The amendments authorize the expanded use of the RealStar MERS-CoV RT-PCR Kit U.S. to include the in vitro qualitative detection of genomic RNA from MERS-CoV in nasopharyngeal swabs from asymptomatic individuals suspected of exposure to MERS-CoV based on epidemiological risk factors (e.g., contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-Co V cases were detected, or other epidemiologic links for which MERS-CoV testing may be indicated). The amendments also include a new Fact Sheet for Asymptomatic Individuals Suspected of Exposure to MERS-CoV Cases and revisions to the Instructions for Use, and Fact Sheets for Health Care Providers and Patients.


2013 H7N9 Influenza Emergency Use Authorization (Potential Emergency)

On April 19, 2013 Secretary Kathleen Sebelius determined that avian influenza A(H7N9) poses a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad. On the basis of this determination the Secretary declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the avian influenza A(H7N9) virus.

Note that Secretary's determination and declaration were issued based on revised authorities under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA).

On April 22, 2013, the FDA issued an Emergency Use Authorization (EUA) for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay. This test is for the presumptive detection of novel influenza A (H7N9) virus in conjunction with the FDA cleared CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel in real-time RT-PCR (rRT-PCR) assays in patients with signs and symptoms of respiratory infection. This device will be distributed by CDC to the public health and other qualified laboratories.

In response to CDC's request to amend this EUA, on March 27, 2018 FDA reissued the April 22, 2013, EUA in its entirety with the CDC-requested amendments incorporated. The amendments: (1) update nucleic acid extraction options authorized for use with the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A(H7) [Eurasian Lineage] Assay; (2) provide users with additional guidance on reporting/referring presumptive positive results to CDC; and (3) as described in Section IV. Conditions of Authorization of this letter, enable certain changes or additions to be made by CDC in consultation with, and with concurrence by, FDA's Division of Microbiology Devices (DMD)/Office of In Vitro Diagnostics and Radiological Health (OIR)/Center for Devices and Radiological Health (CDRH). The Instructions for Use and Fact Sheets also have been updated to incorporate these amendments, where applicable.

On February 14, 2014, the FDA issued an Emergency Use Authorization (EUA) for the Lyra Influenza A Subtype H7N9 Assay manufactured by Quidel Corporation. This test is for the presumptive detection of novel influenza A (H7N9) virus (detected in China in 2013) in patients with signs and symptoms of respiratory infection who have positive specimens for influenza A viral RNA that are determined to be un-subtypable.

On April 25, 2014, the FDA issued an Emergency Use Authorization (EUA) for the "A/H7N9 Influenza Rapid Test" manufactured by Arbor Vita Corporation. This test is for the presumptive detection of the influenza A (H7N9) virus (detected in China in 2013) for use by Department of Defense (DoD) network laboratories in the U.S. and outside the U.S. or other U.S. government laboratories outside the U.S. for patients with signs and symptoms of respiratory infection in conjunction with epidemiological risk factors, or foreign laboratories. It is intended for testing U.S. citizens living and traveling abroad in China and other affected areas and for U.S. military, Department of State, and other U.S. governmental agency personnel stationed and working in China and other affected areas who may potentially be exposed to influenza A (H7N9) virus (detected in China in 2013) or be exposed to individuals who may carry the influenza A (H7N9) virus (detected in China in 2013).

Other Resources

Historical Information

Termination of Declaration Letters

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