XPER Technology Premium Pro Blood Glucose Monitoring System

This system is designed exclusively for near-patient testing in clinical chemistry applications, specifically for quantitative measurement of glucose levels in fresh capillary whole blood samples from fingertips. It is intended for use in endocrinology clinic laboratories and physician office laboratories, not for home use.

The system is supplied as a prescription-use device and requires single-use, auto-disabling lancing devices for each test. These lancing devices are not reusable and are designed to disable automatically after use, ensuring patient safety and preventing cross-contamination.

The device itself is not described as sterile in its specifications, but it is intended for clinical use where standard infection control protocols should be followed. Storage instructions are not explicitly detailed in the provided data, but it is recommended to store the meter and accessories in a clean, dry environment, away from direct sunlight or extreme temperatures, as with most medical devices.

The system received FDA 510(k) clearance under the dual-track review process, meaning it was evaluated for substantial equivalence to a predicate device. The decision was made by the Clinical Chemistry advisory committee, and the clearance was granted on November 19, 2024. No third-party review was involved in this authorization process.

The device falls under FDA product code PZI and is classified as a Class II device under regulation 862.1345. It is also associated with multiple registration numbers (e.g., 1832816, 3005670738) and FEI numbers (e.g., 1832816, 3002807423) for tracking and compliance purposes.