# Spectrum Solutions

**Type:** venture
**Status:** Draft
**Confidence:** High
**Tier:** C
**Focus:** saliva collection devices, SDNA-1000, COVID-19 specimen collection, microbial nucleic acid stabilization, in vitro diagnostics accessories, Draper manufacturing
**Primary Location:** Draper, UT
**Utah Location:** Draper, UT
**Region:** Draper
**Map Location:** 12248 S. Lone Peak Pkwy., Suite 106, Draper, UT 84020
**Coordinates:** 40.5342, -111.9045
**Location Precision:** exact
**Location Source:** https://api.fda.gov/device/510k.json?search=k_number:K223497&limit=1
**Updated:** 2026-08-11
**Needs-reviewed:** 2026-08-11
**Pull:** *Draper FDA-cleared saliva collection hardware — COVID-era EUA accessory, now K223497 510(k).*
**Relates:** cites [Source: FDA 510(k) Record — Spectrum Solutions K223497](spectrum-solutions-fda-510k-k223497.md) · https://greatutah.work/pages/spectrum-solutions-fda-510k-k223497.md · https://api.fda.gov/device/510k.json
**Relates:** cites [Source: FDA 510(k) Decision Letter — Spectrum Solutions K223497](spectrum-solutions-fda-k223497-decision-letter.md) · https://greatutah.work/pages/spectrum-solutions-fda-k223497-decision-letter.md · https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223497.pdf

## Summary

**Spectrum Solutions, LLC** (applicant name in FDA records) manufactures the **Spectrum Saliva Collection Device** — trade name **SDNA 1000**, product code **QBD** — at **12248 S. Lone Peak Pkwy., Suite 106, Draper, UT** ([openFDA K223497](spectrum-solutions-fda-510k-k223497.md), [decision letter](spectrum-solutions-fda-k223497-decision-letter.md)). FDA cleared the device **substantially equivalent** on **2023-02-17** for viral nucleic acid collection and stabilization, including samples suspected of containing **SARS-CoV-2** under healthcare supervision ([decision letter](spectrum-solutions-fda-k223497-decision-letter.md)).

During COVID-19, FDA's **EUA200090** amendment for **Infinity BiologiX** explicitly authorized use of the **Spectrum Solutions SDNA-1000 Saliva Collection Device** for saliva testing, including **at-home self-collection** when clinically appropriate ([EUA letter](fda-eua200090-infinity-biologix-letter.md)). That EUA language limits authorization to the **duration of the COVID emergency declaration** unless terminated sooner ([EUA letter](fda-eua200090-infinity-biologix-letter.md)) — the durable post-pandemic record here is the **510(k)**, not the EUA.

## Impact

The captured FDA record establishes that a **Class II** saliva-collection and stabilization device was **designed and cleared from Draper** — a concrete Utah medical-device manufacturing node tied to the COVID testing supply chain via named test sponsors' EUAs. What **none** of the primary captures state is **unit volume** or whether Spectrum shipped **"one of the highest-unit-count medical devices ever shipped from Utah"** — that superlative appears only in uncaptured marketing/press and is **not asserted here**.

**Bet:** the proprietary **inactivating/stabilizing chemistry inside the collection cap** is the compounding asset — the 510(k) indications focus on **room-temperature stabilization** for molecular diagnostics, not on any single pandemic customer.

## Utah Context

FDA registers the applicant at **Draper, Utah** ([K223497](spectrum-solutions-fda-510k-k223497.md)). The lead URL **spectrumsolution.com** (singular) **redirects to an unrelated site** (`simplytest.solutions`) when probed 2026-08-11 — so the wiki does **not** treat that domain as Spectrum Solutions' official site without an archived corporate capture.

## What They Need Now

Captured FDA documents describe **quality/regulatory** contacts (e.g., VP Quality Assurance on the 510(k) letter) but not a public careers page from a verified live corporate site. Open requisitions are unknown.

## Open Questions

- **Website / corporate presence:** `spectrumsolution.com` redirects away from Spectrum Solutions; `spectrumsolutions.com` (plural) serves an unrelated **leadership training** firm — do not conflate ([probe note in Utah Context]).
- **COVID EUA status today:** [EUA letter](fda-eua200090-infinity-biologix-letter.md) states duration-limited emergency use; whether any COVID EUA referencing SDNA-1000 remains active was not re-checked against FDA's current EUA inventory in this shard.
- **Unit counts:** any high-volume shipment figure requires a **self-reported or audited source** — not present in FDA 510(k) or EUA letter captures.
- **No identifier beyond K223497:** no `utah-entity` or `uei` resolved; openFDA establishment search for "Spectrum Solutions" + Draper returned no row in a quick probe.

## Evidence

- [Source: FDA 510(k) Record — Spectrum Solutions K223497](spectrum-solutions-fda-510k-k223497.md) · https://greatutah.work/pages/spectrum-solutions-fda-510k-k223497.md · https://api.fda.gov/device/510k.json?search=k_number:K223497&limit=1
- [Source: FDA 510(k) Decision Letter — Spectrum Solutions K223497](spectrum-solutions-fda-k223497-decision-letter.md) · https://greatutah.work/pages/spectrum-solutions-fda-k223497-decision-letter.md · https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223497.pdf
- [Source: FDA EUA Amendment Letter — Infinity BiologiX (EUA200090)](fda-eua200090-infinity-biologix-letter.md) · https://greatutah.work/pages/fda-eua200090-infinity-biologix-letter.md · https://www.fda.gov/media/137773/download

## See Also

- [Myriad Genetics](myriad-genetics.md) · https://greatutah.work/pages/myriad-genetics.md — another Utah diagnostic-manufacturing reference point