FDA Grants 510(k) Clearance To Abbott For Cyclic-Citrulinated Peptide

The FDA has granted 510(k) clearance to Abbott for an antibody cyclic-citrulinated peptide, or anti-CCP assay, to run on the world class systems. The company said that by this approval an important assay used to aid in the diagnosis of rheumatoid arthritis (RA) will be added on Abbott’s ARCHITECT immunoassay analyzers.

Reportedly, the assay was developed by Axis-Shield to run on Abbott’s ARCHITECT i1000SR and i2000SR systems. The anti-CCP assay is already approved and available on the Abbott ARCHITECT outside the US.

Michael Warmuth, senior vice president of diagnostics at Abbott, said: “The approval of the anti-CCP assay for use on the ARCHITECT provides an important tool for physicians to aid in the early diagnosis of RA. We are pleased to add this assay to the existing panel of autoimmune disease biomarker assays currently available on the ARCHITECT and clinical chemistry platforms as we underscore Abbott’s continued commitment to the area of immunology.”