FDA Releases Decision Summary for KRONUS ZnT8Ab Elisa Assay
The FDA’s recent de novo approval of KRONUS’ ZnT8Ab Elisa assay was based on results from 569 blood samples — 323 from patients with diagnosed type 1 diabetes and 246 from patients with other types of diabetes, autoimmune diseases and clinical conditions, according to a decision summary posted to the agency’s website on Tuesday.
The test identified the zinc transporter 8 autoantibody in 68 percent of the type 1 diabetes cohort and provided false positive results in two percent of samples from the other disease groups, the FDA says. ZnT8Ab is produced by the immune system of people with type 1 diabetes.
A negative result from the test does not rule out a diagnosis of type 1 diabetes, the FDA notes. When used in combination with other tests and clinical information, the KRONUS test may help people with the disease receive timely treatment and diagnosis, the agency says.
The Aug. 20 decision places the device in Class II with special controls. In addition to taking certain risk-mitigation measures, the company must include information that demonstrates the performance characteristics of the test. Also the assay’s complaint labeling must include relevant warnings and a description of the study protocol and performance studies performed.
View the summary at www.accessdata.fda.gov/cdrh_docs/reviews/K140001.pdf. — Kellen Owings
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