IVD Analytical Performance Services at nelson labs
IVD analytical performance is a critical component of the regulatory approval process for IVD devices, as it demonstrates the device’s ability to produce reliable and accurate results.
At Nelson labs we specialize in providing comprehensive analytical studies tailored to meet the rigorous standards set by the U.S. FDA and IVDR.
- Design and development of analytical performance studies in compliance with CLSI, FDA and IVDR.
- 2. Preparing documentation and protocol reviews for regulatory submissions.
- 3. Conducting analytical performance studies and statistical analysis to deliver dependable and precise outcomes.
The typical analytical performance studies involves conducting to evaluate the device’s accuracy, precision, sensitivity, and specificity, as well as other performance characteristics.
- Analytical sensitivity
- Analytical specificity
- Precision (repeatability and reproducibility)
- Accuracy
- Limits of detection
- Cut-off
- InterferenceCross-reactions
- Sample stability
