binx™ health io™ System

Description

The system is a fully automated, rapid, FDA 510(K)-cleared, CLIA-waived instrument intended for use in point-of-care or clinical laboratory settings for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) DNA detection by polymerase chain reaction (PCR) for both males and females.

The binx™ health io™ Instrument is the first ever 510(K), FDA-cleared, CLIA-waived, molecular point-of-care (POC) platform for chlamydia (CT) and gonorrhea (NG) detection in both males and females, enabling same-visit test and treatment.

• The device is fully integrated and provides automated on-demand testing without the need for maintenance or calibration
• Expands access to laboratory comparable testing results in near-patient settings such as primary care offices, urgent cares, student health centers, community clinics, emergency departments, and retail pharmacies
• Provides the ability to test and treat within a single visit which offers improved patient outcomes such as reduced patient anxiety, lower transmission rates, fewer patients lost to follow-up, reduced empirical treatment, and less likelihood of complications or adverse events
• It is an easy-to-use, desktop-sized instrument that can be operated by non-laboratory trained personnel in CLIA-waived settings
• The device provides results comparable to a laboratory-based test for chlamydia and gonorrhea in about 30 minutes rather than days or weeks

Specifications

• Type: Accuracy Reader
• Sample Type: Urine, Vaginal Swab