Roche Accu-Chek Sensor
Device Name:
Accu-Chek Sensor
Manufacturer:
Roche Diagnostics USA, 9115 Hague Road, PO Box 50457, Indianapolis, IN 46250-0457, UNITED STATES.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for both professional use and self-measurement
Measurement Site:
Finger and general Alternative Site Testing
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Device Manual:
Description:
The Roche Accu-Chek Sensor is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for both professional use and self-measurement.
Assessment:
The technology used in the Roche Accu-Chek Sensor, to measure blood glucose, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BG | Medaval | Legacy approval | Older clinical validation; older protocol |
Validation Publications:
SKUP. Report from the evaluation SKUP/2006/48: Accu-Chek Sensor (Roche Diagnostics), a system for blood glucose measurement. Bergen, Norway: SKUP; 2006. 50 p. Available from: skup.org.
15197:2003 - Pass General population (Note: BLS-recorded measurements)
15197:2003 - Pass General population (Note: Subject-recorded measurements)