Source: https://www.fda.gov/medicaldevices/safety/emergencysituations/ucm161496.htm
Timestamp: 2019-04-21 06:10:08+00:00

Document:
This page lists current and terminated Emergency Use Authorizations that make available diagnostic and therapeutic medical devices to diagnose and respond to public health emergencies.
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).
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 September 27, 2017, the FDA issued an Emergency Use Authorization (EUA) for emergency use of Chembio Diagnostic Systems, Inc.'s DPP Zika IgM Assay System for the presumptive qualitative detection of Zika virus IgM antibodies in human serum (plain or separation gel) and fingerstick whole blood, EDTA venous whole blood, or EDTA plasma (each collected alongside a patient-matched serum specimen) specimens collected from individuals meeting the Centers for Disease Control and Prevention (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., 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 that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high or moderate 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). Specimens from symptomatic patients or returning travelers from endemic areas should not be collected prior to 8 days after onset of symptoms or risk of exposure, respectively. Where there are reactive results from the DPP Zika IgM Assay System, confirmation of the presence of anti-Zika IgM antibodies requires additional testing, as described in the Scope of the Letter of Authorization (Section II) and in the authorized Instructions for Use document, and/or consideration alongside test results for other patient-matched specimens using the latest CDC testing algorithms for the diagnosis of Zika virus infection.
In response to Chembio Diagnostic Systems, Inc.'s request, on February 6, 2018 FDA concurred with the modifications to the authorized Instructions for Use for the DPP Zika IgM Assay System to (1) replace the liquid form of the goat anti-human IgG antibodies and heterophilic antibody (HA) interference blocker for treatment of the specimen with the dehydrated form of the reagents placed in the DPP Zika IgM Assay System device, (2) expand the kit storage range from 2 to 8 °C to 2 to 30 °C, and (3) replace the DPP Zika IgM Sample Buffer and DPP Zika IgM Running Buffer vials by a single vial that is labeled DPP Zika IgM Buffer.
In response to Chembio Diagnostic Systems, Inc.'s request, on August 3, 2018 FDA concurred with the modifications to the authorized Instructions for Use labeling for the DPP Zika IgM Assay System to correct some typographical and formatting errors.
On September 18, 2017, the FDA issued an Emergency Use Authorization (EUA) for emergency use of Siemens Healthcare Diagnostics Incorporated's ADVIA Centaur Zika test for the presumptive qualitative detection of Zika virus IgM antibodies in human serum and plasma (potassium EDTA or lithium heparin, each collected alongside a patient-matched serum specimen) specimens collected from individuals meeting the Centers for Disease Control and Prevention (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., 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 that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high or moderate 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). Specimens from symptomatic patients or returning travelers from endemic areas should not be collected prior to 8 days after onset of symptoms or risk of exposure, respectively. Where there are presumptive Zika positive results from the ADVIA Centaur Zika test, confirmation of the presence of anti-Zika IgM antibodies requires additional testing, as described in the Scope of the Letter of Authorization (Section II) and in the authorized Instructions for Use document, and/or consideration alongside test results for other patient-matched specimens using the latest CDC testing algorithms for the diagnosis of Zika virus infection.
In response to Siemens Healthcare Diagnostic Inc.'s request, on November 16, 2017 FDA concurred with the update to the Instructions for Use for the ADVIA Centaur Zika test to improve the overall clarity, make some minor editorial modifications and to correct some typographical errors.
In response to Siemens Healthcare Diagnostic Inc.’s request, on April 18, 2019 FDA concurred with the request to modify the ADVIA Centaur Zika test to include surfactant in the ADVIA Centaur Zika IgM assay reagent buffers and the related updates of the Instructions for Use for the ADVIA Centaur Zika test to (1) include the new clinical and analytical data collected to support the modification granted in this letter, (2) include updated recommendations for specimen storage based on recent specimen stability studies, and (3) correct some minor typographical errors to improve the overall clarity. FDA also concurred with the update to the Instructions for Use for the (1) Zika Ab (ZikaAb) Quality Control, and (2) Zika IgM (ZikaM) Quality Control to include the 60-day open vial storage claim.
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 April 5, 2017, the FDA issued an Emergency Use Authorization (EUA) for emergency use of DiaSorin Incorporated's ("DiaSorin") LIAISON XL Zika Capture IgM Assay for the presumptive qualitative detection of Zika virus IgM antibodies in human sera collected from individuals meeting the Centers for Disease Control and Prevention (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., 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 that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high or moderate 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). Specimens used with the LIAISON XL Zika Capture IgM Assay should be collected between 8 days and 10 weeks after risk of exposure or onset of symptoms. Where there are presumptive Zika IgM positive and presumptive recent Zika positive results from the LIAISON XL Zika Capture IgM Assay, confirmation of the presence of anti-Zika IgM antibodies requires additional testing, as described in the Scope of Authorization of the authorization letter (Section II) and in the authorized Instructions for Use document, and/or consideration alongside test results for other patient-matched specimens using the latest CDC testing algorithms for the diagnosis of Zika virus infection.
In response to DiaSorin Incorporated's request, on November 6, 2017 FDA concurred with the update to the Instructions for Use for the LIAISON XL Zika Capture IgM Assay to: (1) improve the overall clarity of the procedural steps involved in the proper handling of the conjugates provided with the kit, (2) add a section on conditions of authorization for the laboratory to align with latest EUA requirements, and (3) include the 95% confidence interval for the negative percent agreement.
In response to DiaSorin Incorporated’s request, on December 27, 2018 FDA concurred with the modifications to the authorized Instructions for Use labeling for the LIAISON XL Zika Capture IgM assay to (1) replace the original ZIKV-M conjugate with an updated version of the reagent, (2) change the ZIKV-M calibrators from liquid to lyophilized form, (3) update the calibrator target values, (4) update the unopened kit shelf life stability claim, (5) update in-use stability claim for the ZIKV-M calibrators, (6) increase the number of vials included in the assay kit for each ZIKV-M calibrator to two to facilitate kit calibration over the existing 21 day reagent open-use stability claim, and (7) extend re-calibration frequency of the LIAISON XL Zika Capture IgM assay from 7 to 14 days. FDA also concurred with the related updates of the Instructions for Use and the Fact Sheets for the LIAISON XL Zika Capture IgM II that reflect the modifications described and DiaSorin’s request to modify the name from LIAISON XL Zika Capture IgM to LIAISON XL Zika Capture IgM II.
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. Positive results are indicative of current infection.
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 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. Positive results are indicative of current infection.
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 August 17, 2016, the FDA issued an Emergency Use Authorization (EUA) for emergency use of InBios International, Inc.'s ("InBios"), ZIKV Detect IgM Capture ELISA for the presumptive detection of Zika virus IgM antibodies in human sera collected from individuals meeting the Centers for Disease Control and Prevention (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., 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 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. Where there are presumptive Zika positive, possible Zika positive, or presumptive other flavivirus positive results from the ZIKV Detect IgM Capture ELISA, confirmation of the presence of anti-Zika IgM antibodies or other flavivirus IgM antibodies requires additional testing, as described in the authorized Instructions for Use document, and/or consideration alongside test results for other patient-matched specimens using the latest CDC guideline for the diagnosis of Zika virus infection.
In response to InBios International, Inc.'s request, on March 27, 2017 FDA concurred with the modifications to the authorized Instructions for Use labeling for the ZIKV Detect IgM Capture ELISA to improve the overall clarity of the procedural steps involved in the ZIKV Detect IgM Capture ELISA and to modify the Fact Sheets authorized with the ZIKV Detect IgM Capture ELISA 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.
On August 4, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the Luminex Corporation's xMAP MultiFLEX Zika RNA Assay for the qualitative detection of RNA from Zika virus in human serum, 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.
In response to Luminex Corporation's request, on January 7, 2017, FDA concurred with the modifications to the authorized xMAP MultiFlex Zika RNA Assay 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 Luminex's request, on May 19, 2017 FDA concurred with the modifications to the authorized Instructions for Use labeling and Fact Sheets for the xMAP MultiFLEX Zika RNA Assay to include some minor updates and clarifications requested by FDA.
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 with the latest CDC Zika Laboratory Guidance, implemented in November 2016.
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 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 CDC's request, on September 26, 2018 FDA concurred with the modifications to include a minor update to improve clarity.
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.
On February 6, 2015, 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 EV-D68. 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 the detection of EV-D68, subject to the terms of any authorization issued under 21 U.S.C. § 360bbb-3(a).
On May 12, 2015, the FDA issued an Emergency Use Authorization (EUA) for the Centers for Disease Control and Prevention (CDC) Enterovirus D68 2014 Real-time RT-PCR Assay (EV-D68 2014 rRT-PCR) for the in vitro qualitative detection of RNA from the Enterovirus D68 (EV-D68) strains detected in North America in 2014 in upper respiratory specimens (such as nasopharyngeal (NP) swabs, oropharyngeal (OP) swabs, dual NP/OP swabs, and/or nasal washes) and sera in conjunction with patient-matched upper respiratory specimen(s) from individuals with signs and symptoms of EV-D68 infection and/or epidemiologic risk factors, by qualified laboratories designated by CDC on specified instruments. This device will be distributed by CDC to qualified laboratories designated by CDC.
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.
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.
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.
On October 25, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the BioFire Defense, LLC's FilmArray NGDS BT-E Assay 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 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 FilmArray NGDS BT-E Assay on only the FilmArray Instrument by laboratories designated by the United States Department of Defense (DoD). In response to BioFire Defense, LLC's request to amend this EUA, on March 2, 2015, FDA reissued the October 25, 2014, EUA in its entirety with the BioFire Defense, LLC requested amendment incorporated. The amendments authorize use of plasma and serum specimens with the FilmArray NGDS BT-E Assay in addition to whole blood. 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 specimen types" when requested by BioFire Defense, LLC and concurred with 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.
Please be advised: OraSure Technologies Inc. has issued a recall for the OraQuick Ebola Rapid Antigen Test lot number 6648965. Please visit the CDRH recalls database for more information.
On July 31, 2015, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the OraQuick Ebola Rapid Antigen Test for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in venipuncture whole blood or fingerstick whole blood specimens from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors (including geographic locations with high prevalence of Ebola infection), by laboratories and facilities adequately equipped, trained, and capable of testing for Ebola infection (including treatment centers and public health clinics). The test may also detect antigens from Sudan Ebola virus and Bundibugyo Ebola virus; however, it does not distinguish between these different Ebola virus species. The OraQuick Ebola Rapid Antigen Test is intended for circumstances when the use of a rapid Ebola virus test is determined to be more appropriate than the use of an authorized Ebola virus nucleic acid test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus. The OraQuick Ebola Rapid Antigen Test is not intended for use for general Ebola virus infection screening, such as airport screening or contact tracing of individuals without signs and symptoms of Ebola infection.
In response to OraSure Technologies, Inc.’s request, on January 30, 2019 FDA concurred with the modifications to the authorized Instructions for Use labeling for the OraQuick Ebola Rapid Antigen Test for use with Whole Blood to include new data on (1) Clinical Performance, (2) Interference, (3) Cross Reactivity and (4) Reproducibility of the device and to modify minor wording in the intended use of the device.
On March 4, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the OraQuick Ebola Rapid Antigen Test for the detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in cadaveric oral fluid swab specimens from individuals with epidemiological risk factors for Ebola virus infection and suspected to have died of Ebola. The test is intended to aid in diagnosing Ebola Zaire virus infection as the cause of death in order to inform decisions on safe and dignified burial procedures to prevent transmission of Ebola virus in the community. The OraQuick Ebola Rapid Antigen Test for use with cadaveric oral fluid is not intended for use with oral fluid specimens from living individuals.
In response to OraSure Technologie's request on September 26, 2016, FDA concurred with the modification of the Manufacturer Instructions/Package Insert (Instructions for Use) of the OraQuick Ebola Rapid Antigen Test - For Use with Cadaveric Oral Fluid under the emergency use authorization issued on March 4, 2016. The Manufacturer Instructions/Package Insert has been updated to include additional performance data ((1) LoD with cadaveric oral fluid; (2) interference testing with oral fluid and (3) additional cross reactivity data) to comply with condition Q in the original Authorization Letter from March 4, 2016.
In response to OraSure Technologies, Inc.’s request, on February 1, 2019 FDA concurred with the modifications to the authorized Instructions for Use labeling for the OraQuick Ebola Rapid Antigen Test for use with Cadaveric Oral Fluid to include new data on (1) Clinical Performance, (2) Cross Reactivity and (3) Reproducibility of the device.
On May 26, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the Idylla Ebola Virus Triage Test for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) on the Idylla Instrument System (Idylla System) in EDTA venous whole blood specimens from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors. The Idylla Ebola Virus Triage Test should be performed by laboratories in CLIA moderate and high complexity laboratories in the U.S. or in similarly qualified non-U.S. laboratories, by clinical laboratory personnel who have received specific training on the use of the Idylla Ebola Virus Triage Test on the Idylla System.
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.
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.
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.
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).

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