Thank you, David! We have been able to watch the results go across from the BBIS into Beaker and vice versa, and it has been quite fast so far! I'll keep an eye out for it as we move forward.
For this inquiry, we did reach out to the FDA. In case it's ever helpful for anyone else, here's what they sent back: :)
"Thank you for your inquiry. Your request was forwarded to the FDA Devices Review Branch (DRB) and they provided the following response:
According to 21 CFR 864.9165 Blood Establishment Computer Software (BECS) is a device used in the manufacture of blood and blood components to assist in the prevention of disease in humans by identifying ineligible donors, by preventing the release of unsuitable blood and blood components for transfusion or further manufacturing into products for human treatment or diagnosis, by performing compatibility testing between donor and recipient, or by performing positive identification of patients and blood components at the point of transfusion to prevent transfusion reactions. A FDA cleared BECS device is required for performing the functions that meet the definition above. According to the information you provided below, Kleihauer-Betke testing doesn’t fall under the definition of BECS. We are unable to comment on products that do not meet the definition of BECS, thus this decision falls under your discretion."
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