The digital pathology system can be used for primary diagnosis as a result of the 510(k) clearance, which followed a multicenter study conducted at five clinical sites.
The immunoassays are are indicated for the quantitative determination of IgM RF antibodies and the semi-quantitative determination of IgA RF antibodies.
The agency said that it is the first diagnostic test for detecting Zika virus immunoglobulin (IgM) antibodies that it has allowed to be marketed in the US.
The QiaStat-Dx system will now be commercially available in the US along with a panel that detects more than 20 respiratory viral and bacterial pathogens.