This standard specifies the terms and definitions, requirements, test methods, labels, instructions for use, packaging, transportation and storage requirements for creatine kinase assay reagents (kits). This standard applies to creatine kinase assay reagents (boxes) that use continuous monitoring methods to quantitatively detect creatine kinase activity in serum or plasma, including manual reagents and reagents used on semi-automatic and fully-automatic biochemical analyzers. This standard does not apply to dry creatine kinase assay reagents (boxes).