Luminex Corporation ARIES SARS-CoV-2 FDA 510(k) Clearance
Closed Special Notice Posted
A later notice was posted: the Limited / Sole Source Justification from .
- Solicitation number
- BARDA-06362022
- Agency
-
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Place of performance
- Austin, Texas 78727, United States
Notice details come from SAM.gov. Updated .
About this opportunity
This Special Notice announces the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response's intent to sole source a contract to Luminex Corporation. The notice seeks to award Luminex a firm-fixed price contract to obtain FDA 510(k) clearance for their proprietary ARIES Flu A/B/RSV + SARS-CoV-2 diagnostic test.
The objective is to have Luminex perform the necessary clinical evaluations and 510(k) submission work to achieve long-term FDA clearance of their ARIES test. This clearance is critical to the agency's pandemic response efforts. Interested parties must contact the points of contact by July 27, 2022 at 2:00pm Eastern to express interest in the requirement, which has an estimated total value of [dollar amount redacted] over 12 months of performance. The attached justification finds Luminex is the only company capable of performing this work due to the proprietary nature of their ARIES platform. No other authorized vendors for this requirement were identified in a market survey.
Notice text
This is a notice of intent to sole source to Luminex Corporation for the required clinical and development work to obtain U.S. Food and Drug Administration (FDA) Section 510(k) clearance of Luminex Corporation’s combined ARIES ® Flu A/B/RSV + Coronavirus (SARS-CoV-2 test using simplified acquisition procedures. FDA 510(k) clearance will allow Luminex to commercially market their combined SARS-CoV-2, influenza A, influenza B, and Respiratory syncytial virus (RSV) diagnostic test that operate on the proprietary ARIES® platform. Interested vendors should contact the POCs listed in this notice prior to July 27, 2022 at 2:00pm Eastern.
Files
| File | Type | Posted |
|---|---|---|
| FAR 13.5_SSJ_Certain Commercial Items_Draft Redacted.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| Luminex Corporation ARIES SARS-CoV-2 FDA 510(k) Clearance | Limited / Sole Source Justification | |
| This notice | Special Notice |
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