FDA ISSUES GUIDANCE ON SPECIAL CONTROLS FOR CYSTIC FIBROSIS ASSAYS
Firms should establish special controls to ensure the safety and effectiveness of quality control (QC) materials for cystic fibrosis nucleic acid assays, the FDA said in a recent guidance.
QC materials are designed to monitor the reliability of a test system "by detecting analytical deviations such as those that may arise from reagent or instrument variation in genetic testing," the FDA said. This category of device includes recombinant, synthetic and cell line-based DNA controls. A particular QC material may monitor an entire test system or only one aspect of it.
The guidance recommends that firms include information on the composition of the material in their 510(k) applications and detail the study design used to evaluate each device's performance characteristics.
Preanalytical evaluation should include matrix effects, meaning the influence of the property of a sample other than the analyte on the measured value of that analyte, the guidance states. For example, modifications such as preservatives, stabilizing agents, antimicrobials and clarifying agents are often added to enhance the usability and stability of a material.