Freckmann et al. Evaluation of 12 BGM Systems for Self-Testing: System Accuracy & Measurement Reproducibility. DTT. Vol 16, No 2, 2014.
| Year: | 2014 | |||
|---|---|---|---|---|
| Author’s Country: | Germany | |||
| # BGMs: | 10 | |||
| % ISO 2003 | 100% | |||
| % ISO 2013 | 80% | |||
| % FDA Cleared: | 20% | |||
| % FDA Cleared Meeting ISO 2013: | 100% | |||
| % FDA Cleared Meeting ISO 2003: | 100% | |||
| Meter Name | Company | Cleared? | ISO 2003 | ISO 2013 |
| Accu-Chek Aviva | Roche Diagnostics | Yes | Yes | Yes |
| BGStar | AgaMatrix Inc | Yes | Yes | Yes |
| Contour XT | Bayer Consumer Care | No | Yes | Yes |
| GE 100 | Bionime Corp | No | Yes | Yes |
| GE 200 | Bionime Corp | No | Yes | Yes |
| GL 40 | Beurer GmBH | No | Yes | No |
| myLife Pura | Bionime Corp | No | Yes | Yes |
| mylife Unio | Bionime Corp | No | Yes | Yes |
| Omnitest 3 | B. Braun Melsungen | No | Yes | No |
| OneTouch Verio Pro | LifeScan Europe | No | Yes | Yes |