SUNNYVALE, Calif., Sept. 18 /PRNewswire/ -- Biocircuits Corporation
(Nasdaq: BIOC) today announced that it has filed a 510(k) pre-market
notification with the U.S. Food and Drug Administration (FDA) for marketing
clearance of its Quantitative hCG assay.  The Quantitative hCG assay is
designed to be used with the Company's IOS(TM) immunodiagnostic system to
allow testing in physicians' offices and other points of patient care.
    The Quantitative hCG assay is used to track the progress of early
pregnancies.  Of the nearly 4.3 million Quantitative hCG assays ordered
annually in the United States by office-based physicians, nearly 3.6 million
are sent to facilities outside physicians' offices.
    "The Quantitative hCG assay has the potential to expand further the
clinical and diagnostic utility of our IOS system," said John Kaiser,
President and Chief Executive Officer of Biocircuits.  "The Company has now
filed 510(k) pre-market notifications with FDA for five assays in the last
fifteen months."
    Biocircuits is targeting the approximately 41,000 small to medium-sized
physician o?fice practices and free-standing alternate site laboratories which
are licensed under CLIA for high or moderate complexity testing.  Most of
these sites do not currently have an immunodiagnostic testing capability.  The
IOS system is approved for moderately complex testing.
    Biocircuits Corporation, based in Sunnyvale, California, is focused on the
development and commercialization of innovative and cost-effective
immunodiagnostic products.
    Actual results may differ materially from the above forward-looking
statements due to a number of important factors, and will be dependent upon
the Company's ability, directly or through third parties, to successfully
manufacture and market its existing products, as well as the timely
development and regulatory approval of additional products.  These factors are
more fully discussed in the Company's most recent Forms 10-K and 10-Q.

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