FDA Emergency Approval for CDC Zika IgM test; Warning to Another Company

On February 26, the FDA and CDC collaborated to announce that the CDC could undertake emergency distribution of a Zika IgM test with emergency FDA approval (here).  The CDC test is called the "CDC Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA)."

However, FDA is not overlooking unapproved emergency tests.  On  March 4, the FDA sent a warning letter to "MD Bioscience" that its Zika Virus RNA (RT PCR) assay was an unapproved test in the eyes of the FDA, not under 510(k) nor PMA nor emergency approvals (here).  The FDA's letter to MD Bioscience in St. Paul MN is online here.  The FDA notes specifically that the RNA RT PCR assay was "intended to provide a reliable, accurate and rapid method of testing for Zika virus."  The FDA adds drily that this phrasing "appears to meet the definition of a device."

Later, on March 10, First Diagnostic of Colorado got an FDA letter for its unapproved IgG/IgM test (here).  On March 2, letters also went out to Texas Children's Hospital and Houston Methodist Hospital (here).

Cover in the subscription source Gray Sheet (here).