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 Roche Diagnostics, Taidoc Technology Corporation and Nova Biomedical Corporation.
FDA 510(k) Cleared Prescription Use Blood Glucose Meter For Near-patient Testing Devices (Product Code PZI)
About Product Code PZI - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code PZI since 2014, with 13 receiving FDA clearance (average review time: 300 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under PZI have taken an average of 925 days to reach a decision - up from 248 days historically. Manufacturers should account for longer review timelines in current project planning.
PZI devices are reviewed by the Chemistry panel. Browse all Chemistry devices →