Draper FDA-cleared saliva collection hardware — COVID-era EUA accessory, now K223497 510(k).

Spectrum Solutions

venture confidence: High status: Draft updated 2026-08-11

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
Relates: cites Source: FDA 510(k) Record — Spectrum Solutions K223497 · https://api.fda.gov/device/510k.json
Relates: cites Source: FDA 510(k) Decision Letter — Spectrum Solutions K223497 · 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, decision letter). 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).

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). That EUA language limits authorization to the duration of the COVID emergency declaration unless terminated sooner (EUA letter) — 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). 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 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.