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The Cue COVID-19 Molecular Test is a nucleic acid amplification assay that is used with the Cue Health Monitoring System (Cue Cartridge Reader) for the rapid, qualitative detection of SARS-CoV-2 nucleic acid directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19 (i.e., symptomatic). A negative test result is presumptive, and it is recommended these results be confirmed by a lab-based molecular SARS-CoV-2 assay if necessary for patient management. Negative results do not preclude SARS-CoV-2 infections and should not be used as the sole basis for treatment. Positive results do not rule out co-infection with other respiratory pathogens. This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. This test is intended to be sold over-the-counter (OTC) for testing of individuals 18 years of age and older.

The Cue Health Monitoring System consists of the Cue Cartridge Reader, charging cable and power adapter. The Cue Cartridge Reader is an automated analyzer for use with Cue cartridges and the Cue Health App installed on a mobile smart device (e.q., Apple® iPhone®, Android™) to perform in vitro diagnostic testing. The Cue system is designed to be an easy-to-use, portable testing device for use at home and in point-of-care CLIA Waived settings. Cue cartridges contain the reagents and associated materials required for sample testing which occurs inside the cartridge. Sample analysis takes place within the Cue Cartridge Reader and the test result is wirelessly sent to the user's mobile smart device. The Cue test result is displayed to the user in the Cue Health App installed on a compatible mobile smart device. The main steps for using the Cue Cartridge Reader with the Cue COVID-19 Molecular Test Cartridge are: (1) install the Cue Health App on a compatible mobile smart device and register for a Cue Health App account; (2) connect the mobile smart device with the Cue Cartridge Reader (this allows for the test result to be sent to the particular mobile smart device); (3) insert the Cue COVID-19 Molecular Test Cartridge into the Cue Cartridge Reader; (4) collect a nasal sample using the Cue Sample Wand; and (5) insert the Cue Sample Wand with nasal sample into the Cue COVID-19 Molecular Test Cartridge. Testing starts automatically once the Cue Sample Wand is inserted into the cartridge and proceeds without intervention from the user. When the test is completed, the Cue test result is automatically sent to the user's mobile smart device via BLUETOOTH® technology and displayed to the user in the Cue Health App installed on the mobile smart device. The Cue Sample Wand: The Cue Sample Wand is a single-use, sterile, disposable swab used for collection of a nasal swab sample from the anterior of the human nose. The Wand is comprised of a plastic wand handle and flocked tip. The flock fiber material, fiber adhesive, and handle have been tested for biocompatibility. The Cue COVID-19 Molecular Test Cartridge: The Cue COVID-19 Molecular Test Cartridge contains the reagents and associated materials required for detection of COVID-19 in nasal samples collected using the Cue Sample Wand. Each cartridge contains an internal control that controls for the process steps of the Cue test (e.g., sample collection, pellet mixing, amplification). Testing takes place within the cartridge. Testing duration is approximately 20 minutes from Sample Wand insertion to results. The Cue COVID-19 Molecular Test Cartridge and the sterile Cue Sample Wand are packaged together; both are single-use only. The Cue Health App: The Cue Cartridge Reader interfaces with the user through the Cue Health App installed on the user's mobile smart device. The Cue Health App enables the user to create a Cue Health App account and connect the mobile smart device to the Cue Cartridge Reader. The Cue Health App also provides the user with the precautions and limitations of the Cue COVID-19 Molecular Test, video tutorials for sample collection and running the test, and is the primary display of the test results.

The Cue COVID-19 Molecular Test is a nucleic acid amplification assay that is used with the Cue Health Monitoring System (Cue Cartridge Reader) for the rapid, qualitative detection of SARS-CoV-2 nucleic acid directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19 (i.e., symptomatic). A negative test result is presumptive, and it is recommended these results be confirmed by a labbased molecular SARS-CoV-2 assay if necessary for patient management. Negative results do not preclude SARS-CoV-2 infections and should not be used as the sole basis for treatment. Positive results do not rule out co-infection with other respiratory pathogens. This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. This test is intended to be sold over-the-counter (OTC) for testing of individuals 18 years of age and older.

The device consists of the Cue Health Monitoring System (Cue Reader), the Cue COVID-19 Molecular Test Cartridge, and the Cue sample wand. Users must first download and install the Cue Health App onto their mobile smart device. Users then create an account (first time use) and pair the Cue Reader with the mobile smart device. Multiple profiles can be set up under each user account. The appropriate profile is selected and the user inserts the Cue COVID-19 Molecular Test Cartridge into the Cue Reader. The Cue COVID-19 Molecular Test Cartridge must warm up prior to initiating a run. The user collects an anterior nasal swab sample by swabbing both nares with the Cue sample wand and then inserts the Cue sample wand nasal sample into the port of the Cue COVID-19 Molecular Test Cartridge. The test will start as soon as the Cue Sample Wand is inserted into the Cue COVID-19 Molecular Test Cartridge and is completed in 20 minutes. The Cue Health App will show the Cue COVID-19 Molecular Test result when the test is complete. The result is saved in the Cue Account profile that was selected before the test started.