Background: During the Aviva Universal Coding Project, Phase 3, there is a change to the meter AST Claim by removing thigh and calf areas. This change will be made now to support the upcoming no code meter projects. The history behind this change: Over the past many years Indianapolis bGM groups have relied on historical testing data to retain our AST claims which included the calf and thigh areas. Due to changes in the global regulatory environment, now many additional studies with very difficult recruitment and acceptance criteria that adds significant time and cost to each project just to retain AST claims for the thigh and calf are required for the meters. In addition, there is a highly likely chance that the calf and thigh would not pass the acceptance criteria in the end. The business decision was made by Indianapolis bGM group global stakeholders for APAC, EMEA, Latam, and NA regions that due to the increased demands of testing requirements, high level of risk in obtaining the claims, increased time and cost to projects, and low needs of the customers, the thigh and calf AST claims will no longer be made.​ 

Impact on Accu-Chek FastClix, Accu-Chek Multiclix, Accu-Chek Softclix/Plus AST LANCING DEVICE AST Claim:​ 
We will not remove thigh and calf from the alternate site list in the lancing device AST instructions, but will add a generic disclaimer that the customer should refer to their bGM manual or contact Customer Care to check if AST is supported and which alternate sites are supported. This will be implemented during 2013 within the general lancing/AST insert update to also include new cleaning and disinfections instructions.​ 
We will further continue to state the two palm sites as preferred alternate sites.