Cue Health, Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

your firm implemented several changes to your EUA-authorized devices and implemented those changes without authorization from FDA pursuant to the Conditions of Authorization. For example, documentation showed that on October 23, 2023, your firm implemented change order CP-4166 to both EUA-authorized COVID-19 devices. As part of this change order, it appears that you implemented changes in the formulation of your **(b)(4)**, which serves as a substrate for the reaction and is responsible for generating the signal to detect the presence of the target, modified the **(b)(4)** and updated the device firmware to add functionality to detect failure of **(b)(4)**, and added a **(b)(4)** to modify the raw electrochemical signal from the reaction to correct for observed temperature-based signal differences, and that these changes were implemented after your firm received an EUA-authorization for your devices and in the absence of notification or FDA concurrence.

Passage 2

your firm is using an Acceptable Quality Level (AQL) for functional testing of the COVID-19 cartridges when testing against negative panels which would allow for a failure rate for commercially released product to be higher than the stated Negative Percent Agreement (NPA) clinical performance claims for the EUA devices. Your EUA-authorized devices have a claimed performance of 99.1% Negative Percent Agreement (NPA). However, your lot release activities indicate that you are using an AQL of **(b)(4)**% which is not sufficient to ensure that tests released for distribution have the analytical and clinical performance claimed in the authorized labeling.