Source: FDA 510(k) Decision Letter — Spectrum Solutions K223497

Summary

FDA's substantial equivalence decision letter for Spectrum Solutions, LLC's saliva collection device, dated February 17, 2023. Confirms intended use for viral nucleic acid collection/stabilization including samples suspected of containing SARS-CoV-2 under healthcare supervision.

Useful Claims

• Letter to Spectrum Solutions, LLC, 12248 South Lone Peak Pkwy, Ste 106, Draper, Utah 84020, re K223497.
• FDA determined the Spectrum Saliva Collection Device is substantially equivalent for the stated indications for use.
• Trade/proprietary name: Spectrum Solutions Saliva Collection Device; common name SDNA 1000; product code QBD.
• Indications include non-invasive collection, inactivation, and stabilization of viral nucleic acids for in vitro diagnostic testing of saliva samples, including use with molecular diagnostic devices; intended for healthcare-provider supervision for samples suspected of containing SARS-CoV-2.

Verbatim

"Re: K223497 Trade/Device Name: Spectrum Saliva Collection Device" — letter header

"have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices" — decision paragraph

"Common or Usual Name: SDNA 1000" — device information table

"12248 S. Lone Peak Parkway, Ste 106 Draper, UT 84020" — submitter address block

Reliability Notes

Primary tier FDA decision document. Establishes regulatory identity and Draper address; does not state shipment volumes or rank the device among Utah medical-device outputs.

Related Pages

• Spectrum Solutions
• Source: FDA 510(k) Record — Spectrum Solutions K223497