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Revocation of Emergency Use Authorizations of Zika, Ebola Diagnostics

Neural Impact of Zika Virus Infection

OraSure and DiaSorin diagnostics received other classifications for use which removed them from EUA eligibility.

The following is a summarized notice which appeared in the Federal Register on 8 January 2020.

The Food and Drug Administration (FDA) is announcing the revocation of three Emergency Use Authorizations (EUAs) issued to OraSure Technologies, Inc. for the OraQuick Ebola Rapid Antigen Test used with whole blood specimens; OraSure for the OraQuick Ebola Rapid Antigen Test used with cadaveric oral fluid swab specimens; and DiaSorin Inc. for the LIAISON XL Zika Capture IgM II assay.

FDA revoked both of OraSure’s Authorizations on October 10, 2019, under the Federal Food, Drug, and Cosmetic Act in consideration of a De Novo classification request granted to OraSure for the OraQuick Ebola Rapid Antigen Test on October 10, 2019.

FDA revoked DiaSorin’s Authorization on October 28, 2019, under the FD&C Act, in consideration of the premarket clearance of DiaSorin’s LIAISON XL Zika Capture IgM II assay, which FDA determined to be substantially equivalent to a legally marketed class II predicate device on October 28, 2019.

Background

Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations.

First, on July 31, 2015, FDA issued an EUA to OraSure for the OraQuick Ebola Rapid Antigen Test used with whole blood specimens, subject to the terms of the Authorization. Notice of the issuance of the Authorization was published in the Federal Register on September 14, 2015 (80 FR 55125), as required by section 564(h)(1) of the FD&C Act. In response to requests from OraSure, this EUA was amended on March 18, 2016, and January 30, 2019.

Second, on March 4, 2016, FDA issued an EUA to OraSure for the OraQuick Ebola Rapid Antigen Test used with cadaveric oral fluid, subject to the terms of the Authorization. Notice of the issuance of the Authorization was published in the Federal Register on April 22, 2016 (81 FR 23709), as required by section 564(h)(1) of the FD&C Act. In response to requests from OraSure, this EUA was amended on November 14, 2016, and February 1, 2019. Subsequently, on October 10, 2019, FDA granted a De Novo classification request for the OraQuick Ebola Rapid Antigen Test under the generic name “Device to detect antigens of biothreat microbial agents in human clinical specimens,” as Class II (special controls) under product code QID (https://www.accessdata.fda.gov/​cdrh_​docs/​pdf19/​DEN190025.pdf).

Third, on April 5, 2017, FDA issued an EUA to DiaSorin for the LIAISON XL Start Printed Page 911Zika Capture IgM II assay, subject to the terms of the Authorization. Notice of the issuance of the Authorization was published in the Federal Register on June 30, 2017 (82 FR 29886), and corrected on July 10, 2017 (82 FR 31783), as required by section 564(h)(1) of the FD&C Act. In response to requests from DiaSorin, this EUA was amended on November 6, 2017, and December 27, 2018. Subsequently, DiaSorin submitted a premarket notification to FDA for the LIAISON XL Zika Capture IgM II assay. On October 28, 2019, FDA determined that the LIAISON XL Zika Capture IgM II assay was substantially equivalent to a legally marketed class II predicate device under product code QFO with the generic name “Zika virus serological reagents” (https://www.accessdata.fda.gov/​cdrh_​docs/​pdf19/​K192046.pdf).

EUA Criteria for Issuance No Longer Met

Under section 564(g)(2) of the FD&C Act, the Secretary of HHS may revoke an EUA if, among other things, the criteria for issuance are no longer met. Under section 564(c)(3) of the FD&C Act, an EUA may be issued only if FDA concludes there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition.

On October 10, 2019, FDA revoked the EUAs for OraSure’s OraQuick Ebola Rapid Antigen Test for use with whole blood specimens and cadaveric oral fluid, and on October 28, 2019, FDA revoked the EUA for DiaSorin’s LIAISON XL Zika Capture IgM II assay because the criteria for issuance were no longer met. FDA determined that the criteria for issuance of OraSure’s two Authorizations are no longer met because OraSure had a De Novo classification request granted for the OraQuick Ebola Rapid Antigen Test as a Class II device under the generic name “Device to detect antigens of biothreat microbial agents in human clinical specimens” on October 10, 2019.

FDA also determined that the criteria for issuance of DiaSorin’s Authorization are no longer met because the LIAISON XL Zika Capture IgM II assay was determined to be substantially equivalent to a legally marketed class II predicate device with the generic name “Zika virus serological reagents.” As such, in each case FDA concluded that there is an adequate, approved, and available alternative for purposes of section 564(c)(3) of the FD&C Act and accordingly revoked the Authorizations pursuant to section 564(g)(2)(B) of the Act.

Having concluded that the criteria for revocations of the Authorizations under section 564(g) of the FD&C Act are met, FDA has revoked the EUAs for OraSure’s OraQuick Ebola Rapid Antigen Test for use with whole blood specimens and cadaveric oral fluid and for DiaSorin’s LIAISON XL Zika Capture IgM II assay. The revocations in their entirety follow and provide an explanation of the reasons for each revocation, as required by section 564(h)(1) of the FD&C Act.

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