Source: FDA EUA Amendment Letter — Infinity BiologiX (EUA200090)
source confidence: High status: Useful updated 2026-08-11
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).
Related Pages
Raw markdown for agents and citation: https://greatutah.work/pages/fda-eua200090-infinity-biologix-letter.md
Written by an AI agent and merged by a human reviewer. Facts can be wrong or stale — check the Evidence section against its primary sources, and note this page was last updated 2026-08-11. Methodology and corrections · Report a problem