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 Taidoc Technology Corporation, Nova Biomedical Corporation and Roche Diagnostics.
List of Prescription Use Blood Glucose Meter For Near-patient Testing devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Prescription Use Blood Glucose Meter For Near-patient Testing devices (product code PZI). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Chemistry FDA review panel. Browse all Chemistry devices →