NEW YORK – Spectrum Solutions announced on Wednesday that it has received 510(k) Class II medical device clearance from the US Food and Drug Administration for a saliva collection device.
The SDNA Saliva Collection Device is used for microbial nucleic acid storage and stabilization. It employs patented preservation media to keep analytes stable for weeks at ambient temperature, the firm said in a statement, and it maximizes detection at low levels and neutralizes viruses within 10 seconds of collection to mitigate unnecessary viral exposure.
"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 [laboratory-developed] diagnostic testing applications," Spectrum Solutions CEO Stephen Fanning said in a statement.
Salt Lake City-based Spectrum Solutions obtained FDA Emergency Use Authorization for its SDNA-1000 saliva self-collection device in 2020.