This requirement is to improve the OraQuick® Ebola Rapid Antigent Test. The OraQuick® Ebola Rapid Antigen Test 510(k) was cleared by FDA in October 2019. As of June 2022, there is limited supply of critical reagents (both control and diagnostic antibodies) used in the Ebola 510(k) cleared device. The Government seeks to make the Ebola 510(k) cleared device independent of the aforementioned critical reagents, improve manufacturing capabilities, sensitivity and shelf in order to better respond to public health emergencies. Therefore, the project scope will be expanded beyond preliminary device performance testing, with a goal to improve the quality of the test performance and stability.

The attached J&A amendment approved on 9/14/2023 increases the J&A ceiling and revises the Statement of Work to include the completion of analytical and clinical validation studies and regulatory activities for 510(k) clearance of the second-generation OraQuick® Ebola Rapid Antigen Test. The modification was determined to be in-scope.