🏠
📞  +353 1 6643768
 
📧  info@medaval.ie
Philosys Gmate Origin (PG-310)
Device Name:
Gmate Origin
Device Model:
PG-310
Manufacturer:
Philosys Inc., Suite 218, 304 Park Avenue, NY 10010, UNITED STATES.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Discontinued but still available
Description:
The Philosys Gmate Origin (PG-310) is an automatic blood glucose meter. The accuracy of its blood glucose measurement technology has yet to be proven to MDR requirements. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
While the technology used in the Philosys Gmate Origin (PG-310), to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval None While a clinical validation is claimed, it cannot be checked properly.
BG Institute of Health Economics (CA) General use No evidence provided