> they should have some accountability for non-detected positives The device has been given a class II clearance by the FDA, which means it has to “ provide re

> they should have some accountability for non-detected positives The device has been given a class II clearance by the FDA, which means it has to “ provide reasonable assurance of safety and effectiveness “. False negative rates are definitely one of the things that are considered in getting this. That doesn’t mean false negatives aren’t possible.