FDA 510(k) approval, page-3

UBI is a designer and manufacturer of point of care test strips, using novel technology. It partners with large market players: Johnson & Johnson for blood glucose testing (for diabetics to test their sugar before deciding on an insulin dose), and Siemens for blood coagulation testing. The blood glucose strips have been in the market for several years, and generates income for UBI.

The Siemens blood coagulation testing machine (Xprecia Stride) has to be cleared by the FDA 510(k) process before Siemens can start marketing these point of care tests in the US. The standard that must be achieved is called "Substantial Equivalence" (to one or more existing machines already on the market). There was a problem last year with another machine on the market, so the whole approval process appears to have been delayed while the FDA committee responsible for the decision reviewed its decision-making processes. There was a chance that Siemens would be rejected, or have to provide additional data. Whatever happened, the machine has now been approved, so it appears that Siemens can start selling the device. At this stage, only the decision has been posted; sometimes, perhaps later, they also post a summary report on the decision.