Inova Diagnostics Announces New Assay FDA Clearances

Inova Diagnostics has won FDA 510(k) clearance on several Quanta Flash assays for use with the company’s Bio-Flash chemiluminescent analyzer for autoimmune testing. 

The assays consist of extractable nuclear antigen tests for diagnosis of connective tissue diseases such as systemic lupus erythematosus, Sjogren’s syndrome and systemic sclerosis, the San Diego, Calif., devicemaker says.

Inova Diagnostics also announced FDA approval for its Flash Beta-2 Glycoprotein1 Domain1, a highly specific marker for antiphospholipid syndrome.

The Bio-Flash menu also includes tests for celiac disease and vasculitis. — Jason Scott