On August 6, 2020, based on the FDA's continued review of the scientific evidence available for Autobio Diagnostics Co. Ltd.'s Anti-SARS-CoV-2 Rapid Test for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood (Heparin / EDTA / sodium citrate) or serum 2, including evidence from an NIH/NCI independent evaluation, the FDA determined that the statutory criteria for the authorization in Section 564(c)(2) of the Federal Food, Drug, and Cosmetic (FD&C) Act are no longer met. Specifically, the FDA determined that it is not reasonable to believe the product may be effective in detecting IgM antibodies against SARS-CoV-2 or that the known and potential benefits of the device when used for this purpose outweigh its known and potential risks. The FDA also concluded that based on the risks to public health from false test results, revocation is appropriate to protect the public health or safety. Accordingly, the EUA was revoked under Section 564(g)(2)(B) & (C) of the FD&C Act.

On June 16, 2020, based on the FDA's continued review of the scientific evidence available for Chembio Diagnostic Systems, Inc.'s DPP COVID-19 IgM/IgG System for detection of IgM and IgG antibodies against SARS-CoV-2, including evidence from an NIH/NCI independent evaluation, the FDA determined that the statutory criteria for issuing an EUA in Section 564(c)(2) of the Federal Food, Drug, and Cosmetic (FD&C) Act are no longer met. Specifically, the FDA determined that it is not reasonable to believe the product may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of the device when used for this purpose outweigh its known and potential risks. The FDA also concluded that based on the risks to public health from false test results, revocation is appropriate to protect the public health or safety. Accordingly, the EUA was revoked under Section 564(g)(2)(B) & (C) of the FD&C Act.

On April 28, 2020, FDA issued an umbrella EUA for SARS-CoV-2 Antibody Tests (Lateral flow or Enzyme-linked immunosorbent assay (ELISA) tests) that have been evaluated in an independent validation study performed at the National Institutes of Health's (NIH) National Cancer Institute (NCI), or by another government agency designated by the FDA, and are confirmed by the FDA to meet the criteria set forth in the Scope of Authorization of the EUA.  To date, however, no device has been added to the list of authorized devices in Appendix A of the letter of authorization.

On July 21, 2020, FDA determined, based on information and experience since issuing this EUA, that circumstances support revocation of this umbrella EUA so that FDA may issue individual EUAs. Individual EUAs will allow for broader indications and scopes of authorization, individualized conditions of authorization to address any issue unique to a specific test, and more streamlined EUA amendments, such as additional uses that would not fall under this umbrella EUA.

Accordingly, the EUA was revoked under Section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic (FD&C) Act.