Device Dossier

Clinical chemistry therapeutic drug monitoring IVDs

Device Dossier for Clinical chemistry therapeutic drug monitoring IVDs (CT860 - Clinical chemistry therapeutic drug monitoring IVDs, Class 3, sponsor…

Intended purpose

The ARCHITECT iValproic Acid assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of valproic acid, an anticonvulsant drug, in human serum or plasma on the ARCHITECT iSystem with STAT protocol capability. The measurements obtained are used in monitoring levels of valproic acid to help ensure appropriate therapy.

TGA Public Summary