TeleRPM Gen2 Blood Glucose Monitoring System

The TeleRPM Gen2 Blood Glucose Monitoring System measures glucose concentration in capillary whole blood samples from fingertips using an electrochemical amperometric biosensor. It is intended for home use by persons with diabetes to monitor diabetes control and is not for neonatal use, diagnosis, or screening.

The device uses the same electrochemical biosensor principle, amperometric detection method, glucose oxidase chemistry, measurement range (20–600 mg/dL), sample volume (0.8 μL), test time (5 seconds), operating conditions, and data transmission via 4G wireless as the predicate VivaChek Link Plus. Minor differences include higher battery capacity (1,300 vs. 800 mAh), greater memory (2,000 vs. 500 records), and slightly different dimensions and weight.

Laboratory studies were performed in accordance with FDA SMBG OTC Guidance and CLSI guidelines; industry standards are referenced but not specifically named in this summary.

The TeleRPM Gen2 has identical intended use, operating principle, detection method, chemical composition, measurement result format, sample type, measurement range, and critical performance parameters as the predicate device. Nonclinical studies and clinical evaluations demonstrated equivalent performance against FDA SMBG OTC Guidance and industry standards. Differences (battery capacity, memory, dimensions) are minor design variations that do not affect the fundamental function or safety profile, supporting substantial equivalence.