On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is 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 the virus that causes COVID-19. Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of HHS then declared on March 24, 2020, that circumstances exist justifying the authorization of emergency use of medical devices during the COVID-19 outbreak, subject to the terms of any authorization issued under Section 564(a) of the Act.

Based on the totality of scientific evidence available to FDA, it was concluded that the SDNA-1000 Saliva Collection Device is effective in diagnosing COVID-19 by serving as an appropriate means to collect, stabilize, and maintain during transport, unprocessed saliva specimens suspected of containing SARS-CoV-2 RNA and that the known and potential benefits of your product when used for such use, outweigh the known and potential risks of your product. It is also believed that there is no adequate, approved, and available alternative to the emergency use of your product. 

  • The SDNA-1000 sample collection device has been authorized only for the collection and maintenance of saliva as an aid in the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
  • The SDNA-1000 sample collection device is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in medical devices during the COVID-19 outbreak under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked.
  • The SDNA-1000 sample collection device has not been FDA cleared or approved, The SDNA-1000 is authorized by FDA under an EUA.
  • Spectrum Solutions was delivered EUA 202432 for its SDNA-1000 Saliva Collection Device
  • This device specific EUA officially means any lab EUA authorized to test samples for COVID-19 using one of the five EUA Authorized commercial RNA extraction chemistries can now integrated saliva as a diagnostic sample option, exclusively using the SDNA-1000, without the need to file for a new EUA specific to saliva.