What types of Quantitative Results are required in 510(k)

[jewels]

All of our previous devices are qualitative tests with + or - results. We are now designing some quantitative tests (kits used in laboratories to test patient samples) and are not sure which of the quantitative data should be listed in the 510(k). I couldn't find any reference to what to include for Specific Performance Characteristics to help me since the description is vague. Here are the parameters we will be providing data for:

imprecision reported as sd or %cv (within run, day to day, total)

accuracy (usually slope and intercept of a regression analysis to a comparative method)

assay range, linearity, recovery

expected values (results from testing normal population)

cutoff (if we are going to make any claims about how the results are used)

detection limit or analytical sensitivity

interfering substances (endogenous and specific drugs or other therapeutic reagents)[/SIZE]

I suggested that whatever we think the user needs to know in addition to accuracy/sensitivity/specificity should be included in the Specific Performance Characteristics section of the insert. From there, we would need to include the data to support those statements in the 510(k).

Any suggestions for applicable EU requirements would be helpful too.

 

[Al Rosen]

All of our previous devices are qualitative tests with + or - results. We are now designing some quantitative tests (kits used in laboratories to test patient samples) and are not sure which of the quantitative data should be listed in the 510(k). I couldn't find any reference to what to include for Specific Performance Characteristics to help me since the description is vague. Here are the parameters we will be providing data for:

imprecision reported as sd or %cv (within run, day to day, total)

accuracy (usually slope and intercept of a regression analysis to a comparative method)

assay range, linearity, recovery

expected values (results from testing normal population)

cutoff (if we are going to make any claims about how the results are used)

detection limit or analytical sensitivity

interfering substances (endogenous and specific drugs or other therapeutic reagents)[/SIZE]

I suggested that whatever we think the user needs to know in addition to accuracy/sensitivity/specificity should be included in the Specific Performance Characteristics section of the insert. From there, we would need to include the data to support those statements in the 510(k).

Any suggestions for applicable EU requirements would be helpful too.

I don't have experience in this area, but perhaps someone with IVD experience can help? BTW, are you able to get a copy of the 510(k) of the device to which you are claming SE?