
Theranos Herpes Simplex Virus-1 IgG Assay 510(k) [pdf] - jerryhuang100
http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143236.pdf
======
jerryhuang100
(This is an extension of my previous comment [1])

The table 3 in their (only) approved HSV-1 IgG assay 510(k) seems funny:

A) No body just check some simple math?

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 just
=\= the total of 78.

B) Their SD values distributions in table 4 vs numbers of devices (table 3)
shows a distinct pattern between small and large numbers of devices used in
their precision study.

[http://imgur.com/HLTKGfM](http://imgur.com/HLTKGfM)

[1]
[https://news.ycombinator.com/reply?id=10816704](https://news.ycombinator.com/reply?id=10816704)

