# Source: FDA EUA Amendment Letter — Infinity BiologiX (EUA200090)

**Type:** source
**Status:** Useful
**Confidence:** High
**Source Type:** government-record
**URL:** https://www.fda.gov/media/137773/download
**Publisher:** U.S. Food and Drug Administration
**Retrieved:** 2026-08-12
**Raw:** raw/fda-eua200090-infinity-biologix-letter/2026-08-11-86ae047d9f54.txt
**Updated:** 2026-08-11
**Relates:** cites [Spectrum Solutions](spectrum-solutions.md) · https://greatutah.work/pages/spectrum-solutions.md · https://www.fda.gov/media/137773/download

## Summary

FDA **August 18, 2021** EUA amendment letter for **Infinity BiologiX LLC**'s TaqPath SARS-CoV-2 assay (**EUA200090**). The authorization explicitly permits saliva specimens collected with the **Spectrum Solutions SDNA-1000 Saliva Collection Device** — evidence that FDA tied Utah-made collection hardware into a named COVID test EUA.

## Useful Claims

- The assay may use saliva **collected in a healthcare setting by individuals using the Spectrum Solutions SDNA-1000 Saliva Collection Device**.
- The letter authorizes **self-collection of saliva specimens at home or in a healthcare setting** using the **Spectrum Solutions LLC SDNA-1000 Saliva Collection Device** when appropriate — expanding at-home collection under this EUA amendment.
- EUA conditions state the product **has been authorized only for the detection of nucleic acid from SARS-CoV-2** and that emergency use is authorized **only for the duration of the declaration** under section 564(b)(1), **unless the declaration is terminated or authorization is revoked sooner**.
- The letter names **Spectrum Solutions SDNA-1000 Saliva Collection Device** among authorized materials but is addressed to **Infinity BiologiX**, not Spectrum Solutions — the EUA attaches to a **test sponsor's** authorization, not a standalone manufacturer EUA file captured here.

## Verbatim

> "When determined to be appropriate by a healthcare provider, this test is also for use with saliva specimens that are self-collected at home using the IBX Saliva Collection Kit or that are collected in a healthcare setting by individuals using the Spectrum Solutions SDNA-1000 Saliva Collection Device."
> — Indication section

> "This product has been authorized only for the detection of nucleic acid from SARS-CoV-2"
> — Conditions of authorization

> "• The emergency use of this product is only authorized for the duration of the"
> — Conditions of authorization (bullet list)

## Reliability Notes

Primary tier FDA letter. Documents COVID-era EUA scope for the SDNA-1000 device as an accessory to Infinity BiologiX's test. **Does not establish that EUA200090 remains in force after the COVID public-health emergency wound down** — the letter itself states duration limits. Post-COVID marketing status rests on the **510(k)** record ([K223497](spectrum-solutions-fda-510k-k223497.md)).

## Related Pages

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