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.
Availability: Commercially Available
| 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, power adapter |
| Data Analysis Support Equipment |
| Cartridge Reader, Cue Health app |
| Communications Interface |
| Bluetooth, USB |
| Shelf Life |
| >5 years |
| Maintenance Cost |
| Minimal |
| Tested For Biological Agents |
| No |
| Other Biological Targets |
| SARS CoV-2 |
| Adaptability |
| No; cannot detect or add new targets |
| 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 |
