The marketing authorization does not impact the
availability of the 14 other Zika nucleic acid diagnostics available under
Today, the U.S. Food and Drug Administration authorized
marketing of a diagnostic test to detect Zika virus immunoglobulin
(IgM) antibodies in human blood to InBios International, Inc.
The ZIKV Detect 2.0 IgM Capture ELISA is the first
Zika diagnostic test the FDA has allowed to be marketed in the U.S.;
previously, tests for detecting Zika virus IgM antibodies—including the ZIKV
Detect 2.0 IgM Capture ELISA—had been authorized only for emergency use
under the FDA’s Emergency Use Authorization (EUA)
The FDA reviewed data for the ZIKV Detect 2.0 IgM Capture ELISA test through the de novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. Along with this authorization, the FDA is establishing criteria, called special controls, that determine the requirements for demonstrating accuracy, reliability and effectiveness of tests intended to identify Zika virus antibodies.
These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.