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LAFAYETTE, Colo. -- Meretek Diagnostics Inc. announces that Otsuka Pharmaceutical Co., Ltd. (Japan) received Food and Drug Administration (FDA) clearance of its
510(k) application to market the POCone Infrared Spectrophotometer. The POCone is a new instrument which offers several technological
advancements to aid in the detection of active H. pylori infection, and to
confirm eradication of infection through the patented 13C urea breath test
technology and methodology.
The POCone is an in-vitro diagnostic device designed to measure the change
of 13CO2 concentration in breath by infrared spectroscopic analysis and is
intended for use in conjunction with the BreathTek urea breath test, which
is commercially available through Meretek. Urea breath testing is considered
the non-invasive gold standard for H. pylori infection, the leading cause of
peptic ulcer disease. As the newest advancement in the Meretek family of
breath test technologies, the POCone offers physicians and practice staff the
following advantages when testing for active H. pylori infection:
-- Software upgrade - Test administrators are now able to input letters
and numbers to further complement patient identification information
at the time of a breath sample collection. Additionally, an internal
timer alerts administrators to the optimal sample collection time
during the 15-minute testing period.
-- Improved result time - Results from analyzed breath test samples are
available in approximately 2 minutes.
-- Improved warm-up time - The POCone warms up in approximately 10
minutes, reduced from 45 minutes.
-- Reduced size - The smaller, table-top design requires limited office
or laboratory space (8.6"W x 10"H x 12.75"D).
-- Light weight - The unit weight makes it practically mobile (23 pounds).
"Meretek is committed to the continued research and development of
technological platforms for effective, proactive H. pylori management," said
Sara Davis, director of the marketing department for Meretek Diagnostics Inc.
"Today's announcement demonstrates our vision to improve health care in the
United States by providing the medical community with advanced instrumentation
for detecting active H. pylori infection and confirming eradication."
The POCone Infrared Spectrophotometer is available for use in the
qualitative detection of urease associated with H. pylori in the human stomach
and as an aid in the initial diagnosis and post-treatment monitoring of
infection in adults.
Source: Meretek Diagnostics Inc.