Thanks for the response. To clarify, the device is a class 2 device that has a 510(k) clearance. it's definitely not an IVD. It's a device that has a diagnostic use. If the company decides in the future to market the modified device, then the company will follow the process for determining whether a new 510(k) needs to be followed. However, at this time the modified version is meant to be used for research purposes. the modification is being made at the request of a research institution that wants to study some specific patient characteristics in conjunction with the use of the device. I don't know if there will be a formal study with a protocol, and the company will make only one device at this time. there will be IRB approval of the device use.