Cue Health Receives ISO 13485 Certification
San Diego, CA—(July 3, 2018)--Cue Health Inc. (“Cue”), a healthcare technology company developing a connected diagnostics platform for professionals and consumers today announced that it received its ISO 13485 certification from British Standards Institution (BSI).
The ISO 13485:2016 standard for medical devices represents the requirements for a comprehensive management system for the design and manufacture of medical devices. The specific scope of the certification achieved is for the design and development, manufacture and distribution of in-vitro diagnostic medical devices used in the detection, diagnosis and management of infectious diseases, women’s health, cardiovascular health, wellness, and other diseases and conditions.
“The ISO certification is a fundamentally important recognition of Cue’s processes to develop and manufacture diagnostic products for medical use,” said Ayub Khattak, CEO of Cue Health Inc.
The ISO certification is an internationally recognized standard. The FDA recently announced it planned adoption of the ISO 13485:2016 standard to harmonize the Quality Systems aspect of the regulation of medical devices with the international standard.
“We are proud of the system we have built to receive this important certification for medical device development and in vitro diagnostic (IVD) manufacturing,” said Siaw-Yen Lim, Director of Quality for Cue Health Inc.
About the Cue Health Monitoring System
The Cue Health Monitoring System is a portable, compact, connected diagnostic platform that provides the power of lab-quality molecular testing at point-of-care, when and where it is needed the most. The Cue Health Monitoring system works with the Cue Test Cartridge, the Cue Sample Wand, and the Cue Health App to convert test samples into accurate digital results. The single-use Cue Test Cartridge contains all the biochemistry needed to perform the molecular test. The Cue Sample Wand is a nasal swab supplied with the Cue Test Cartridge. The reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results directly to the Cue Health App in about 20 minutes via a mobile smart device. The Cue Health App on the user’s mobile smart device is the user interface for test information, instructions, and display of the test results. Designed as a complete diagnostic tool, the Cue Health Monitoring System along with the Cue Test Cartridge and the Cue Health App deliver actionable health data at point-of-care.
COVID-19 Test Cartridge
The Cue COVID-19 Test Cartridge is a single-use, self-contained unit that utilizes proprietary technology to apply the reagents and associated materials required for molecular detection of the SARS-CoV-2 virus, the virus that causes COVID-19. The Cue COVID-19 Test is a high-sensitivity molecular assay that is being deployed to address urgent unmet needs in COVID-19 testing. On June 10, 2020, Cue received Emergency Use Authorization (EUA) from the US Food and Drug Administration for use of the Cue COVID-19 Test Cartridge with the Cue Health Monitoring System to detect nucleic acid from SARS-CoV-2 in nasal specimens from individuals who are suspected of COVID-19 by their healthcare provider.
About Cue Health
Cue Health Inc. (“Cue”) is an ISO 13485-certified company founded by Ayub Khattak and Clint Sever focused on developing and manufacturing professional and consumer medical diagnostic products that can be used in clinical or at-home settings. Cue’s mission is to create tools that empower healthcare providers and consumers by increasing their access to actionable health data. Cue’s first product, the Cue Health Monitoring System with the Cue COVID-19 Test Cartridge, is a platform that provides diagnostic information to clinicians and patients seeking to benefit from a connected healthcare delivery ecosystem. The company is based in San Diego, CA. For more information visit www.cuehealth.com
This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by authorized laboratories; this test has been authorized only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens; and this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
July 3, 2018
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