Extract to table

Class II Special Controls As a Class II device with special controls, the Lumina CGM System must satisfy both general controls under Section 510(a)–(h) of the FD&C Act and the applicable special controls identified for product code QKQ devices

The device must demonstrate clinical accuracy through a well-designed clinical study

Interference testing must evaluate the effects of common exogenous and endogenous substances (e

Software contained in or associated with the device must be validated in accordance with FDA guidance and applicable standards, including IEC 62304:2006/A1:2015

The C14 sensor, as a sterile implantable device, must demonstrate sterility assurance consistent with applicable standards (e

Sterility validation data must be included in the 510(k) submission