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

**Type:** source
**Status:** Useful
**Confidence:** High
**Source Type:** government-record
**URL:** https://api.fda.gov/device/510k.json?search=k_number:K223497&limit=1
**Publisher:** U.S. Food and Drug Administration (openFDA)
**Retrieved:** 2026-08-12
**Updated:** 2026-08-11
**Relates:** cites [Spectrum Solutions](spectrum-solutions.md) · https://greatutah.work/pages/spectrum-solutions.md · https://api.fda.gov/device/510k.json

## Summary

openFDA 510(k) index row for **Spectrum Solutions, LLC**'s **Spectrum Saliva Collection Device**, cleared **2023-02-17** with product code **QBD**. Establishes Draper, Utah manufacturing address independent of the company's website.

## Useful Claims

- **Applicant:** Spectrum Solutions, LLC.
- **K number:** K223497; **decision date:** 2023-02-17; **decision_code:** SESE (openFDA's code for this clearance record).
- **Device name:** Spectrum Saliva Collection Device; **product code:** QBD (Microbial Nucleic Acid Storage And Stabilization Device, Class II).
- **Address:** 12248 S. Lone Peak Pkwy., Suite 106, **Draper, UT**.

## Verbatim

Structured API fields quoted from the openFDA response: `applicant` = "Spectrum Solutions, LLC", `k_number` = "K223497", `decision_date` = "2023-02-17", `decision_code` = "SESE", `device_name` = "Spectrum Saliva Collection Device", `product_code` = "QBD", `city` = "Draper", `state` = "UT", `address_1` = "12248 S. Lone Peak Pkwy., Suite 106".

## Reliability Notes

Primary tier at FDA's host, re-derivable by K number. This is a **510(k) clearance** record — durable post-COVID — distinct from time-limited COVID EUAs that named the same device family for SARS-CoV-2 specimen collection.

## Related Pages

- [Spectrum Solutions](spectrum-solutions.md)
- [Source: FDA 510(k) Decision Letter — Spectrum Solutions K223497](spectrum-solutions-fda-k223497-decision-letter.md)