Umbrella of Infusion Pumps and Infusion Pump Accessories

On September 21, 2020, FDA has determined that circumstances support revocation of the umbrella EUA to protect the public health or safety. Individual EUAs will allow for tailored indications and scopes of authorization, including but not limited to those for different environments of use, routes of administration, and patient populations. In addition, this would allow for individualized conditions of authorization to address any issue unique to a specific device, and more streamlined EUA amendments, such as additional uses that would not fall under this umbrella EUA. Accordingly, FDA has decided to revoke this EUA. Instead, FDA may issue individual EUAs for infusion pumps and infusion pump accessories that meet the requisite EUA statutory criteria. Accordingly, the EUA was revoked under Section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

05/13/2020
(issued)

09/21/2020
(revoked)

Anti-SARS-CoV-2 Rapid Test (Autobio Diagnostics Co. Ltd.)

On August 6, 2020, based on 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, 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, 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. 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 Accordingly, the EUA was revoked under Section 564(g)(2)(B) & (C) of the FD&C Act.

04/24/2020 (issued)

08/06/2020 (revoked)

DPP COVID-19 IgM/IgG System (Chembio Diagnostic System, Inc.)

On June 16, 2020, FDA revoked the EUA for emergency use of Chembio Diagnostic Systems, Inc.'s DPP COVID-19 IgM/IgG System, which was authorized to detect IgM and IgG antibodies against SARS-CoV-2 in serum and plasma (EDTA or lithium heparin), venous whole blood, or fingerstick whole blood specimens. New information from multiple evaluations of the device's clinical performance were reviewed following authorization and data from these evaluations demonstrated poor clinical performance of the device. Given the poor performance, after consideration of the totality of scientific evidence available to the Agency, FDA determined under section 564(g)(2)(B) that the criteria for issuance of emergency authorization in section 564(c) of the Act were longer met for the DPP COVID-19 IgM/IgG System. Specifically, given the poor device performance, FDA concluded that it was 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 test outweigh its known and potential risks. In addition, based on the same information and the risks to public health from false test results, FDA concluded that revocation is appropriate to protect the public health or safety under section 564(g)(2)(C).

04/14/2020 (issued)

06/16/2020 (revoked)

DPP Zika IgM Assay System (Chembio Diagnostic Systems, Inc.)

Chembio Diagnostic Systems, Inc.'s ("Chembio") DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader (K200506) was determined to be substantially equivalent to a legally marketed Class II predicate device, classified under 21 CFR 866.3935, with the generic name "Zika virus serological reagents," on June 3, 2020. FDA has concluded "that this is an adequate, approved, and available alternative for the Chembio device which was initially authorized for emergency use in 2017 for purposes of section 564(c)(3) of the Act". In the context of section 564, the term "approved" refers to a product that is approved, licensed, or cleared under section 505, 510(k), or 515 of the FD&C Act or section 351 of the Public Health Service Act. See section 564(a)(2) of the FD&C Act. Accordingly, on June 3, 2020, FDA determined that the criteria for issuance of an emergency use authorization (EUA) under section 564(c) of the Act are no longer met and revoked the EUA for DPP Zika IgM Assay System, issued on September 27, 2017, and amended on February 6, 2018, and August 3, 2018, pursuant to section 564(g)(2) of the Act.

[Authorization]
[Amendment]
[Amendment]
 

ADVIA Centaur Zika test (Siemens Healthcare Diagnostics Inc.)

Siemens Healthcare Diagnostics Inc.'s ("Siemens") ADVIA Centaur Zika test (K191578) was determined to be substantially equivalent to a legally marketed Class II predicate device, classified under 21 CFR 866.3935, with the generic name "Zika virus serological reagents," on July 17, 2019. FDA has concluded "that this is an adequate, approved, and available alternative for the Siemens device which was initially authorized for emergency use in 2017 for purposes of section 564(c)(3) of the Act". In the context of section 564, the term "approved" refers to a product that is approved, licensed, or cleared under section 505, 510(k), or 515 of the FD&C Act or section 351 of the Public Health Service Act. See section 564(a)(2) of the FD&C Act. Accordingly, on July 17, 2019, FDA determined that the criteria for issuance of an emergency use authorization (EUA) under section 564(c) of the Act are no longer met and revoked the EUA for ADVIA Centaur Zika test, issued on September 18, 2017, and amended on November 16, 2017, and April 18, 2019, pursuant to section 564(g)(2) of the Act.

ZIKV Detect 2.0 IgM Capture ELISA (InBios International, Inc.)

FDA granted the De Novo classification request for InBios International, Inc.'s ("InBios") ZIKV Detect 2.0 IgM Capture ELISA, and established a new classification regulation for Zika virus serological reagents (class II) in 21 CFR 866.3935 on May 23, 2019 (https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180069.pdf).  FDA has concluded that this is an adequate, approved, and available alternative for the InBios device which was initially authorized for emergency use in 2016. Accordingly, on May 23, 2019, FDA determined that the criteria for issuance of an emergency use authorization (EUA) under section 564(c) of the Act are no longer met and revoked the EUA for ZIKV Detect 2.0 IgM Capture ELISA, issued on August 17, 2016, and amended on March 27, 2017, and May 18, 2018, pursuant to section 564(g)(2) of the Act.

xMAP MultiFLEX Zika RNA Assay (Luminex Corporation)

In a letter to FDA dated June 18, 2019, Luminex Corporation requested that the EUA for the xMAP MultiFLEX Zika RNA Assay issued on August 4, 2016, and amended on January 7, 2017, and May 19, 2017, be withdrawn. Luminex has decided to discontinue manufacture of the product and there is no remaining viable inventory of the xMAP MultiFLEX Zika RNA Assay. As a result, this product will no longer be marketed, and these circumstances make revocation appropriate to protect the public health or safety. Accordingly, on July 3, 2019, FDA revoked the EUA for xMAP MultiFLEX Zika RNA Assay, pursuant to section 564(g)(2) of the Act. As of July 3, 2019, the xMAP MultiFLEX Zika RNA Assay that was authorized by FDA for use by clinical laboratories for the qualitative detection of RNA from Zika virus is no longer authorized by FDA.

OraQuick Ebola Rapid Antigen Test (OraSure Technologies, Inc.)

FDA granted the De Novo classification request for OraSure Technologies Inc.'s ("OraSure's") OraQuick Ebola Rapid Antigen Test, and established a new classification regulation for "Device to detect antigens of biothreat microbial agents in human clinical specimens" (class II) in 21 CFR 866.4002 on October 10, 2019. FDA has concluded that this is an adequate, approved, and available alternative for the OraSure devices which were initially authorized for emergency use in 2015, for use with whole blood specimens and 2016, for cadaveric oral fluid. Accordingly, on October 10, 2019, FDA determined that the criteria for issuance of both emergency use authorizations (EUAs) under section 564(c) of the Federal Food, Drug and Cosmetic Act (the Act) are no longer met and revoked the EUAs for: (1) OraQuick Ebola Rapid Antigen Test for use with whole blood specimens issued on July 31, 2015, and amended on March 18, 2016, and January 30, 2019, and (2) OraQuick Ebola Rapid Antigen Test for use with cadaveric oral fluid issued on March 4, 2016, and amended on November 14, 2016, and February 1, 2019, pursuant to section 564(g)(2) of the Act.