3 ms·
I'm curious how they did their 510(k) or just some simple math for their (only) approved HSV-1 IgG assay [1]: In their "Table 3: Design of Precision Study", th
by jerryhuang100 11y ago
I'm curious how they did their 510(k) or just some simple math for their (only) approved HSV-1 IgG assay [1]:
In their "Table 3: Design of Precision Study", the Equivocal Panel C, Lot 3 is asterisked with the citation of "sufficient cartridges not available". However if you try to sum up the total valid replicates (27 + 44 + 8 = 79) and it just does not match to the total of 78.
[1] http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143236.pdf http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143236.pdf