FDA Product Code PZI: Prescription Use Blood Glucose Meter For Near-patient Testing

Near-patient blood glucose testing enables rapid dosing decisions in intensive care and procedural settings. FDA product code PZI covers prescription-use blood glucose meters cleared for near-patient testing in non-laboratory settings.

These meters are cleared for use by healthcare professionals to measure blood glucose at the bedside for monitoring of hospitalized patients on insulin drips and in perioperative glycemic management, where timely results are critical to preventing hypoglycemia and hyperglycemia.

PZI devices are Class II medical devices, regulated under 21 CFR 862.1345 and reviewed by the FDA Chemistry panel.

Leading manufacturers include Nova Biomedical Corporation, Roche Diagnostics and Arkray, Inc..