Chemistry-PTM-OMA_Modules_1-4

Product Consistency (Lot‐to‐Lot Variability)

• Study to confirm that the manufacturing of the test  kit and its components is consistent among lots • Testing is performed on 3 unique lots • Each lot must be a uniquely manufactured lot  or consist of uniquely prepared reagents,  supplies, and kit components • Can be combined with stability testing in a  single study; if tested independent of stability  testing, age of test kit is not a variable in this  study, only variation among lots