Table 3.
FDA-Cleared BGM Systems Meeting ISO 15197 2003 and ISO 15197 2013 Standards.
| Meter Name | Company | ISO 15197 2003 (32/33 evaluated) | ISO 15197 2013 (31/33 evaluated) |
|---|---|---|---|
| Accu-Chek Active | Roche Diagnostics | Yes | Yes |
| Accu-Chek Aviva | Roche Diagnostics | Yes | Noa |
| Accu-Chek Aviva Plus | Roche Diagnostics | Yes | Yes |
| Accu-Chek Compact | Roche Diagnostics | Yes | Yes |
| Accu-Chek Compact Plus | Roche Diagnostics | Yes | Yes |
| Accu-Chek Go | Roche Diagnostics | Nob | Nob |
| Accu-Chek Performa (maltose dependent) | Roche Diagnostics | Yes | Yes |
| Accu-Chek Performa (maltose independent) | Roche Diagnostics | Yes | Yes |
| Advocate Redi-Code | TaiDoc Technology Corp | No | No |
| alphacheck professional | i-SENS inc | Yes | Yes |
| Ascensia Contour | Bayer HealthCare LLC | Yes | ? |
| BG Star | AgaMatrix | Yes | Noc |
| Breeze | Bayer Health Care | ? | No |
| CareSens N | i-SENS inc | Yes | Yes |
| CareSens N POP | i-SENS inc | Yes | Yes |
| Clever Chek TD-4222 | Taidoc Technology Corp. | No | No |
| Contour | Bayer Consumer Care | Nob | No |
| Contour USB | Bayer Consumer Care AG | Yes | Nob |
| Contour USB Next | Bayer Health Care | Yes | Yes |
| Element | Infopia Co | Yes | No |
| EZ Smart | Tyson Bioresearch | No | No |
| FreeStyle Freedom | Abbott Diabetes Care Inc | Yes | ? |
| FreeStyle Lite | Abbott Diabetes Care Inc | Yes | Nod |
| GM700 | Bionime | Yes | Yes |
| iBG Star | AgaMatrix | Yes | Noe |
| microdot | Cambridge Sensors Limited | Yes | No |
| OneTouch Select | Lifescan | No | No |
| OneTouch Ultra 2 | LifeScan Inc | Yes | Yes |
| OneTouch Verio | Lifescan Inc | Yes | Yes |
| OneTouch VITA | Lifescan Inc | Yes | Yes |
| Prodigy Voice | Diagnostic Devices Inc | No | No |
| TRUEbalance | Nipro Diagnostics | No | No |
| WaveSense Jazz | AgaMatrix | Yes | Yes |
| FDA-cleared BGM systems meeting standards when tested for ISO standards | 24/32 (75%) | 15/31 (48%) | |
Question mark indicates the BGM system was not evaluated against this standard. Of the 98 BGM systems, 33 were FDA-cleared. Of those, 32 were evaluated for ISO 15197 2003 and 31 were evaluated for ISO 15197 2013.
a
Did not meet criteria in 1 of 5 studies.
b
Did not meet criteria in 1 of 2 studies.
c
Did not meet criteria in 1 of 4 studies.
d
Did not meet criteria in 1 of 4 lots of strips in a single study.
e
Did not meet criteria in 1 of 3 studies.