Is the Threshold System approved by the FDA?
The FDA does not approve or disapprove of commercial assay systems. However, there have been many IND’s filed with the FDA that have used the Threshold Total DNA Assay for measuring contaminant DNA, or the Immuno-Ligand Assay for measuring Host Cell Proteins or other protein contaminants, and all have proceeded to clinical trials with no questions that were transmitted to Molecular Devices. There have also been PLAs submitted and approved that have included Threshold Total DNA Assay data and/or Immuno-Ligand Assay data for process validation and/or final QC release. Biopharmaceutical products have been approved in Europe that were validated and/or released with Total DNA and/or Immuno-Ligand Assay data.
