MosaiQ COVID-19 Antibody Magazine (Quotient Suisse SA)

In a request to the FDA received December 22, 2021, Quotient Suisse SA requested that the FDA Emergency Use Authorization (EUA201083) for the MosaiQ COVID-19 Antibody Magazine issued on September 25, 2020 be terminated. Quotient Suisse SA decided not to continue to commercially support the MosaiQ COVID-19 Antibody Magazine. As a result, these circumstances make revocation appropriate to protect the public health or safety.

Accordingly, on January 11, 2022 the FDA revoked the EUA for emergency use of Quotient Suisse SA’s MosaiQ COVID-19 Antibody Magazine, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act.

09/25/2020
(issued)

04/27/2021
(amend)

09/23/2021
(amend)

01/11/2022
(revoked)

[Authorization]

[Amendment]

[Viral Mutation Revision Letter - September 23, 2021]

BioPlex 2200 SARS-CoV-2 IgG (Bio-Rad Laboratories)

In a request to the FDA received December 20, 2021, Bio-Rad Laboratories requested that the FDA Emergency Use Authorization (EUA202689) for the BioPlex 2200 SARS-CoV-2 IgG issued on July 1, 2021 be revoked. The BioPlex 2200 SARS-CoV-2 IgG Panel has not been commercialized by Bio-Rad in the U.S. As a result, these circumstances make revocation appropriate to protect the public health or safety.

Accordingly, on January 11, 2022 the FDA revoked the EUA for emergency use of Bio-Rad Laboratories BioPlex 2200 SARS-CoV-2 IgG, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act.

07/01/2021
(issued)

09/23/2021
(amend)

01/11/2022
(revoked)

[Authorization]

[Viral Mutation Revision Letter - September 23, 2021]

Xpert Omni SARS-CoV-2

In a request to the FDA received December 17, 2021, Cepheid requested that the FDA Emergency Use Authorization (EUA202699) for the Xpert Omni SARS-CoV-2 issued on November 27, 2020 be revoked. Cepheid indicated that due to the current public clinical needs being met by Cepheid’s other EUA tests that are available, Cepheid has not commercially distributed any of the authorized product. As a result, these circumstances make revocation appropriate to protect the public health or safety.

Accordingly, on December 20, 2021, the FDA revoked the EUA for emergency use of Cepheid’s Xpert Omni SARS-CoV-2, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act.

11/27/2020
(issued)

12/23/2020
(amend)

04/20/2021
(amend)

09/23/2021
(amend)

12/20/2021
(revoked)

[Authorization]

[Amendment]

[Viral Mutation Revision Letter - September 23, 2021]

ADVIA Centaur SARS-CoV-2 IgG (COV2G)

In a request to the FDA received December 9, 2021, Siemens Healthcare Diagnostics Inc. (Siemens) requested that the FDA Emergency Use Authorization (EUA201697) for the ADVIA Centaur SARS-CoV-2 IgG (COV2G) issued on July 31, 2020 be removed from FDA’s list of authorized devices. FDA understands that the authorized product is no longer being marketed.

Accordingly, on December 17, 2021, the FDA revoked the EUA for emergency use of Siemens ADVIA Centaur SARS-CoV-2 IgG (COV2G), pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act.

07/31/2020
(issued)

09/23/2021
(amend)

12/17/2021
(revoked)

[Authorization]

[Viral Mutation Revision Letter - September 23, 2021]

Atellica IM SARS-CoV-2 IgG (COV2G)

In a request to the FDA received December 9, 2021, Siemens Healthcare Diagnostics Inc. (Siemens) requested that the FDA Emergency Use Authorization (EUA201696) for the Atellica IM SARS-CoV-2 IgG (COV2G) issued on July 31, 2020 be removed from FDA’s list of authorized devices. FDA understands that the authorized product is no longer being marketed.

Accordingly, on December 17, 2021, the FDA revoked the EUA for emergency use of Siemens Atellica IM SARS-CoV-2 IgG (COV2G), pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act.

07/31/2020
(issued)

09/23/2021
(amend)

12/17/2021
(revoked)

[Authorization]

[Viral Mutation Revision Letter - September 23, 2021]

SARS-COV-2 R-GENE

In a request to the FDA received December 10, 2021, BioMérieux SA requested that the FDA Emergency Use Authorization (EUA200445) for the SARS-COV-2 R-GENE issued on May 6, 2020 be revoked. BioMérieux SA indicated that due to the current public clinical needs being met by other EUA assays that are available on the market, BioMérieux SA has decided to no longer commercially support the authorized product. As a result, these circumstances make revocation appropriate to protect the public health or safety.

Accordingly, on December 17, 2021, the FDA revoked the EUA for emergency use of BioMérieux SA’s SARS-COV-2 R-GENE, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act.

05/06/2020
(issued)

11/06/2020
(amend)

09/23/2021
(amend)

12/17/2021
(revoked)

[Authorization]

[Amendment]

[Viral Mutation Revision Letter - September 23, 2021]

qSARS-CoV-2 IgG/IgM Rapid Test

In a request to the FDA received December 7, 2021, Cellex Inc. requested that the FDA withdraw the Emergency Use Authorization (EUA200058) for the Cellex q-SARS-CoV-2 IgG/IgM Rapid Test issued on April 1, 2020. FDA understands that the product is no longer being distributed. As a result, these circumstances make revocation appropriate to protect the public health or safety.

Accordingly, on December 10, 2021, the FDA revoked the EUA for emergency use of Cellex Inc.’s q-SARS-CoV-2 IgG/IgM Rapid Test, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act.

04/01/2020
(issued)

06/12/2020
(amend)

09/23/2020
(amend)

12/10/2021
(revoked)

[Authorization]

[Viral Mutation Revision Letter - September 23, 2021]

BMC-CReM COVID-19 Test

In a request to the FDA received October 4, 2021, and reconfirmed December 6, 2021, Boston Medical Center requested that the EUA for the BMC-CReM COVID-19 Test issued on July 10, 2020, be revoked. Boston Medical Center confirmed that the BMC-CReM COVID-19 Test is no longer performed pursuant to the EUA. As a result, these circumstances make revocation appropriate to protect the public health or safety.

Accordingly, on December 8, 2021, the FDA revoked the EUA for emergency use of Boston Medical Center’s BMC-CReM COVID-19 Test, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act.

07/10/2020
(issued)

09/25/2020
(amend)

09/23/2021
(amend)

12/08/2021 (revoked)

[Authorization]

[Viral Mutation Revision Letter - September 23, 2021]

Akron Children's Hospital SARS-CoV-2 Assay

In a request to the FDA received December 3, 2021, Akron Children’s Hospital requested that the EUA for the Akron Children's Hospital SARS-CoV-2 Assay issued on September 29, 2020, be revoked. Akron Children’s Hospital confirmed that it stopped performing the Akron Children’s Hospital SARS-CoV-2 Assay, having implemented a number of additional SARS-CoV-2 molecular assays which have received EUA. As a result, these circumstances make revocation appropriate to protect the public health or safety.

Accordingly, on December 8, 2021, the FDA revoked the EUA for emergency use of Akron Children's Hospital’s Akron Children's Hospital SARS-CoV-2 Assay, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act.

09/29/2020
(issued)

09/23/2021
(amend)

12/08/2021
(revoked)

[Authorization]

[Viral Mutation Revision Letter - September 23, 2021]

BioGX SARS-CoV-2 Reagents for BD MAX System

In a request to the FDA received December 3, 2021, Becton, Dickinson & Company’s (BD’s) requested that the EUA for the BioGX SARS-CoV-2 Reagents for BD MAX System issued on April 2, 2020, be revoked. BD indicated that to simplify and focus their BD MAX Portfolio, BD made the decision to discontinue the sale of the authorized product. As a result, these circumstances make revocation appropriate to protect the public health or safety.

Accordingly, on December 8, 2021, the FDA revoked the EUA for emergency use of BD’s BioGX SARS-CoV-2 Reagents for BD MAX System, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act.

04/02/2020
(issued)

04/07/2020
(amend)

05/29/2020
(amend)

09/25/2020
(amend)

09/23/2021
(amend)

12/08/2021
(revoked)

[Authorization]

[Amendment]

[Viral Mutation Revision Letter - September 23, 2021]

TaqPath COVID-19 MS2 Combo Kit 2.0.

In a letter to the FDA dated September 22, 2021, Thermo Fisher Scientific, Inc., on behalf of Life Technologies Corporation (a part of Thermo Fisher Scientific, Inc.), requested that the EUA for the TaqPath COVID-19 MS2 Combo Kit 2.0 issued on August 2, 2021, be revoked. Thermo Fisher Scientific Inc. indicated that it has decided to not commercially support the TaqPath COVID-19 MS2 Combo Kit 2.0 at this time. As a result, these circumstances make revocation appropriate to protect the public health or safety.

08/02/2021
(issued)

09/27/2021
(revoked)

Guardant-19

In a letter to the FDA dated August 2, 2021, Guardant Health Inc. requested that the EUA for the Guardant-19 test issued on August 21, 2020 and amended on December 28, 2020, be revoked. Guardant Health Inc. requested revocation of the Guardant-19 test effective July 16, 2021. As a result, these circumstances make revocation appropriate to protect the public health or safety.

08/21/2020
(issued)

08/06/2021
(revoked)

MatMaCorp COVID-19 2SF Test

In a letter to the FDA dated July 29, 2021, Materials and Machines Corporation of America (DBA MatMaCorp, Inc.) requested that the EUA for the MatMaCorp COVID-19 2SF Test issued on December 17, 2020, be revoked. MatMaCorp, Inc. notified FDA that it will no longer be distributing the MatMaCorp COVID-19 2SF Test as of July 31, 2021. As a result, these circumstances make revocation appropriate to protect the public health or safety.
 
Accordingly, on August 3, 2021, the FDA revoked the EUA for emergency use of MatmaCorp, Inc.’s MatMaCorp COVID-19 2SF Test, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act.

Gravity Diagnostics COVID-19 Assay

In an email request originally received March 11, 2021, and reconfirmed July 12, 2021, Gravity Diagnostics, LLC. requested that the EUA for the Gravity Diagnostics COVID-19 Assay issued on June 1, 2020, and amended on June 30, 2020, and September 21, 2020, be revoked. Gravity Diagnostics, LLC confirmed that it is no longer using the Gravity Diagnostics COVID-19 Assay at Gravity’s laboratory, having transitioned to another EUA-authorized test. As a result, these circumstances make revocation appropriate to protect the public health or safety.

Accordingly, on July 21, 2021, the FDA revoked the EUA for emergency use of Gravity Diagnostics, LLC’s Gravity Diagnostics COVID-19 Assay, pursuant to section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act.

06/01/2020
(issued)
06/30/2020 (amended)

07/21/2021
(revoked)

Curative (formerly Curative-Korva) SARS-Cov-2 Assay

In a letter to the FDA dated June 16, 2021, Curative Inc. requested that the EUA for the Curative SARS-Cov-2 Assay issued on April 16, 2020 under the original name Curative-Korva SARS-Cov-2 Assay, and amended on June 11, 2020, be revoked effective July 15, 2021. Curative stated that it was transitioning to the use of different EUA-authorized SARS-CoV-2 tests for the testing offered at its laboratories. As a result, the Curative test will no longer be used, and these circumstances make revocation appropriate to protect the public health or safety.

Accordingly, on July 15, 2021, the FDA revoked the EUA for emergency use of Curative Inc.’s Curative SARS-Cov-2 Assay (originally authorized as KorvaLabs Inc.’s Curative-Korva SARS-Cov-2 Assay), pursuant to section 564(g)(2)(C) of the Act.

04/16/2020 (issued)
6/11/2020 (amended)

07/15/2021 (revoked)

BioFire Respiratory Panel 2.1 (RP2.1) (BioFire Diagnostics, LLC)

The FDA issued a De Novo classification order for BioFire Diagnostics, BioFire Respiratory Panel 2.1 (RP2.1) as a Class II device under the generic name "Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test" (to be codified in 21 CFR 866.3981) on March 17, 2021. FDA has concluded that this is an adequate, approved, and available alternative for the BioFire Diagnostics, LLC device which was initially authorized for emergency use in 2020. Accordingly, on March 17, 2021, 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 the BioFire Respiratory Panel 2.1 (RP2.1), issued on May 1, 2020, and revised on December 22, 2020, pursuant to section 564(g)(2) of the Act.

12/22/2020
(issued)

03/17/2021
(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.  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.