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

**Type:** source
**Status:** Useful
**Confidence:** High
**Source Type:** government-record
**URL:** https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223497.pdf
**Publisher:** U.S. Food and Drug Administration
**Retrieved:** 2026-08-12
**Raw:** raw/spectrum-solutions-fda-k223497-decision-letter/2026-08-11-553284e5b67d.txt
**Updated:** 2026-08-11
**Relates:** cites [Spectrum Solutions](spectrum-solutions.md) · https://greatutah.work/pages/spectrum-solutions.md · https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223497.pdf

## 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](spectrum-solutions.md)
- [Source: FDA 510(k) Record — Spectrum Solutions K223497](spectrum-solutions-fda-510k-k223497.md)