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FDA Clears Inova Diagnostics Rheumatoid Arthritis Assays

NEW YORK (360Dx) – Inova Diagnostics today said that the US Food and Drug Administration has cleared the firm's Quanta Flash Rheumatoid Factor IgM and Quanta Flash RF IgA assays.

The two chemiluminescent immunoassays are for use in human sera and are indicated for the quantitative determination of IgM RF antibodies and the semi-quantitative determination of IgA RF antibodies. The presence of the antibodies, along with clinical findings and other laboratory tests, are used to help diagnose rheumatoid arthritis.

The clearance of the two tests, San Diego-based Inova said in a statement, expands the number of FDA-cleared assays available for use with the company's Bio-Flash random access chemiluminescent system, which can provide results in as little as 30 minutes.