PTS CardioChek Analyzer
Device Name:
CardioChek Analyzer
Manufacturer:
Polymer Technology Systems Inc. (PTS Diagnostics), 4600 Anson Boulevard, Whitestown, IN 46075, UNITED STATES.
Measuring functions:
Blood glucose, Cholesterol
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The PTS CardioChek Analyzer 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.
Assessment:
While the technology used in the PTS CardioChek Analyzer, to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| 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 |