Cue Health Monitoring System

The Cue Health Monitoring System is an in vitro diagnostic medical device for use with test-specific Cue Cartridge(s) and the Cue Health Mobile Application (Cue Health App) installed on a mobile smart device, delivering results in about 20 minutes. The single-use Cue Cartridges (used with the Cue Sample Wand) contain all the complex biochemistry needed to convert test samples into digital results. The COVID-19 test has Emergency Use approval by the FDA in March 2021.

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Availability: Commercially Available

support@cuehealth.com
+1 833 283 8378
4980 Carroll Canyon Road Suite 100
San Diego, CA 92121
USA
www.cuehealth.com
Manufacturer
Cue Health, Inc.
Product Name
Cue Health Monitoring System
Detection Category
Biological
Detection Principle
Immunological;
Detection Method
Lateral Flow Hand Held Immunoassay;
Application
Diagnostics;Detection;
Equipment Type
Instrument
Product Synopsis
The Cue Health Monitoring System is an in vitro diagnostic medical device for use with test-specific Cue Cartridge(s) and the Cue Health Mobile Application (Cue Health App) installed on a mobile smart device, delivering results in about 20 minutes. The single-use Cue Cartridges (used with the Cue Sample Wand) contain all the complex biochemistry needed to convert test samples into digital results. The COVID-19 test has Emergency Use approval by the FDA in March 2021.
Availability
Commercially Available
Technology Readiness Level (TRL)
9
Market Entry Date
2021
User Feedback Sources
Indifferent/No user feedback
Dimensions
3.0 x 3.0 x 1.5 in. (7.4 x 7.4 x 3.7 cm)
Weight
<1 Lb.; 0.33 Lb. (150 g)
Power Requirements
AC/DC Line Power
Transportability
Handheld
Ruggedness
None
Operating Conditions
15 to 35°C (59 to 95°F), 10-100% RH
Consumables
>$1,000/year; cartridges
Solvents/Reagents
Yes; contained within each cartridge
Available Accessories
Charging cable
Data Analysis Support Equipment
Cartridge Reader, Cue Health app
Communications Interface
Bluetooth, USB
Shelf Life
>5 years
Maintenance Cost
Minimal
Other Biological Targets
SARS CoV-2
Adaptability
No
Sample Introduction
Biological sample
Sensitivity/Detection Limits
CPS; 20 cps
False Positive Rates
<5%
False Negative Rates
<5%
Response Time (Sample Application To Output)
>15 minutes; 20 minutes
Total Run Time
20 minutes
Software Control
Remote
Other Operational Parameters
The sampling wand goes directly from patient's nasal cavity into the Reader with no additional manipulation. Up to six Cue Readers can be synced with each mobile device
Training Required
<1 hour training
Training Available
Yes
Manuals Available
User manual
Warranties
1 year
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