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news.Roche has received a premarket approval (PMA) from the US Food and Drug Administration (FDA) for its IgM antibody to hepatitis B core antigen (Anti-HBc IgM) assay.
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The assay is designed to be used on the company’s cobas e 601 analyzer, an immunoassay module of the cobas 6000 analyzerseries.
The Anti-HBc IgM assay is used to qualitatively detect IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum or plasma.
The company said it is intended to use the assay with its electrochemiluminescence (ECL) technology, a light detection system which provides low-end sensitivity and broad dynamic measuring ranges.
The assay is also pending FDA approval for use on Roche’s cobas e 411 and Modular Analytics E170 analyzers.