PZI

14 FDA 510(k) clearances · Product code

FDA profile

Official device name

Prescription Use Blood Glucose Meter For Near-Patient Testing

Device class

Class II (moderate risk)

Regulation

21 CFR 862.1345

Medical specialty

Clinical Chemistry

FDA definition

Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining dysglycemia.

Adverse events (MAUDE)

2019: 19 · 2021: 18 · 2025: 35 · 2026: 45
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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