Sam Brusco, Associate Editor02.24.23
Spectrum Solutions has earned U.S. Food and Drug Administration (FDA) 510(k) Class II clearance for its SDNA saliva collection device as a microbial nucleic acid storage and stabilization device.
SDNA is renowned for its ability to maximize detection at the lowest levels and neutralize viruses within ten seconds of collection to reduce unnecessary viral exposure. The company’s preservation media keeps analytes stable for weeks at ambient temperatures to ensure safe, easy, and secure specimen storage and transport.
According to the company, near the beginning of the pandemic Spectrum’s SNDA-1000 was the first to gain FDA emergency use authorization and introduce the U.S. to the noninvasive, highly accurate, and earliest detection benefits of COVID-19 testing using saliva self-collection.
The device now has over two years’ experience processing SARS-CoV-2 saliva tests.
“This 510(k) clearance and certification as an IVD molecular diagnostic device enables physicians, hospitals, researchers and others to leverage our SDNA Saliva Collection Device in a broad array of FDA approved and LDT diagnostic testing applications,” Stephen Fanning, CEO at Spectrum Solutions, told the press. “Those conducting screening and diagnostic tests can confidently and safely expand access and opportunity incorporating saliva as a primary or alternative biomaterial into their existing testing protocols.”
“We couldn’t be more excited for the opportunity this new 510(k) device clearance delivers in supporting laboratory medicine and healthcare systems in safely and confidently decentralizing specimen collections for precise and accurate testing,” added Spectrum Solutions chief medical officer Rohit Gupta.
SDNA is renowned for its ability to maximize detection at the lowest levels and neutralize viruses within ten seconds of collection to reduce unnecessary viral exposure. The company’s preservation media keeps analytes stable for weeks at ambient temperatures to ensure safe, easy, and secure specimen storage and transport.
According to the company, near the beginning of the pandemic Spectrum’s SNDA-1000 was the first to gain FDA emergency use authorization and introduce the U.S. to the noninvasive, highly accurate, and earliest detection benefits of COVID-19 testing using saliva self-collection.
The device now has over two years’ experience processing SARS-CoV-2 saliva tests.
“This 510(k) clearance and certification as an IVD molecular diagnostic device enables physicians, hospitals, researchers and others to leverage our SDNA Saliva Collection Device in a broad array of FDA approved and LDT diagnostic testing applications,” Stephen Fanning, CEO at Spectrum Solutions, told the press. “Those conducting screening and diagnostic tests can confidently and safely expand access and opportunity incorporating saliva as a primary or alternative biomaterial into their existing testing protocols.”
“We couldn’t be more excited for the opportunity this new 510(k) device clearance delivers in supporting laboratory medicine and healthcare systems in safely and confidently decentralizing specimen collections for precise and accurate testing,” added Spectrum Solutions chief medical officer Rohit Gupta.