MedikalDevice

Accu-Chek Guide Glucose Meter

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Accu-Chek Guide Glucose Meter

A blood glucose meter that measures glucose in fresh capillary blood on single-use test strips using an FAD-GDH amperometric method. Intended for home self-testing by people with diabetes.

Key facts

ProductAccu-Chek Guide Blood Glucose Monitoring System
ManufacturerRoche Diabetes Care
Intended usersHome / personal use
US FDA status510(k) cleared — K160944
Market statusAvailable

Main features

  • Measuring range 20-600 mg/dL
  • Minimum sample 0.6 µL; fingertip, palm or upper arm
  • Result in under 4 seconds
  • Stores at least 720 results with 7/14/30/90-day averages
  • Illuminated strip port and spill-resistant SmartPack strip vial

Connectivity

Bluetooth Low Energy (mySugr app) and USB to PC.

AI and analysis software

The manufacturer does not describe built-in AI for this device. Because its data can leave the device, it can in principle feed separate analysis software; any such software is a distinct product with its own regulatory status.

Regulatory status in the United States

FDA 510(k) clearance: K160944.

Related guide: Cloud-Based Medical Devices.

Sources

Profile verified against public sources in October 2026. Trademarks belong to their owners.