Microbiology-PTM-OMA_Modules_1-5

Independent Product Consistency Study

• For test methods that have multiple components with different lot identification numbers • Lots of the individual components will be interchanged prior to analysis • Testing will be conducted in same manner as combined consistency/stability study (20  replicates for qualitative, etc.)

Kit Component 1 Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3 Lot 1 Lot 2 Lot 3

Kit Component 2 Lot 1 Lot 1 Lot 1 Lot 2 Lot 2 Lot 2 Lot 3 Lot 3 Lot 3

Kit Component 3 Lot 3 Lot 2 Lot 1 Lot 1 Lot 2 Lot 3 Lot 2 Lot 1 Lot 3