Extract to table

Any design modifications to the electrode coating architecture must be carefully evaluated for their impact on several critical parameters: • Analytical Performance

Any modification to the electrode coating must maintain or improve this performance level

The Pre-Submission (Pre-Sub) meeting package and the subsequent 510(k) submission must accurately describe the commercial embodiment of the Lumina C14 sensor, including its electrode coating architecture

If design modifications are adopted, the device description in these regulatory submissions must reflect the modified design

However, the FTO analysis has practical implications for the regulatory timeline and submission strategy that must be carefully managed: Pre-Sub Meeting Package Alignment

Timeliness is critical, as the design-around assessment must be completed in advance of the Pre-Sub package submission target date