Brazg et al. Performance Variability of 7 Commonly Used SMBG Systems: Clinical Considerations for Patients and Providers. JDST. Vol 7, Iss 1, Jan 2013.
| Year: | 2013 | |||
|---|---|---|---|---|
| Author’s Country: | USA | |||
| # BGMs: | 7 | |||
| % ISO 2003 | 43% | |||
| % ISO 2013 | 14% | |||
| % FDA Cleared: | 71% | |||
| % FDA Cleared Meeting ISO 2013: | 20% | |||
| % FDA Cleared Meeting ISO 2003: | 60% | |||
| Meter Name | Company | Cleared? | ISO 2003 | ISO 2013 |
| Accu-Chek Aviva Plus | Roche Diagnostics | Yes | Yes | Yes |
| Advocate Redo-Code | TaiDoc Technology Corp | Yes | No | No |
| Element | Infopia Co | Yes | Yes | No |
| Embrace | Apex Biotechnology Corp | No | No | No |
| Prodigy Voice | Diagnostic Devices Inc | Yes | No | No |
| TRUEbalance | Nipro Diagnostics | Yes | No | No |
| WaveSense Presto | AgaMatrix | No | Yes | No |