ABBOTT PARK, Ill., Oct. 31, 2017 /PRNewswire/
-- Abbott (NYSE: ABT) has secured U.S. Food and Drug
Administration (FDA) 510(k) clearance for its Alinity™ ci-series
instruments for clinical chemistry and immunoassay diagnostics.
These innovative testing solutions were designed to help the lab
more effectively address modern industry challenges, including
aging populations, growing management of chronic diseases and
increased access to care, which are driving increases in testing
volume.
"Healthcare systems across the United
States are under pressure to deliver better care for
patients," said Brian Blaser,
executive vice president, Diagnostics Products, Abbott. "Labs and
healthcare systems are looking for complete solutions that help
them operate more efficiently while contributing to better clinical
decision making and helping improve patient outcomes. FDA clearance
is a key first step in bringing this important innovation to our
U.S. customers as we work to gain approval for the full Alinity
portfolio of instruments and assays."
The Alinity ci-series is part of a unified family of
personalized solutions that are engineered for flexibility and
efficiency. The design is based on insights from thousands of
customers, resulting in a number of benefits including:
- Smaller footprint: Patented stacked design instead of
linear makes it half the size of existing systems, allowing for
cost-effective volume growth in less space.
- Improved workflow and greater throughput: Delivers more
than 650 tests per hour per square meteri, a significant
increase compared to other available systems, with the capability
to scale up for even greater throughput and the ability to run
urgent tests without waiting for prior samples to complete
testing.
- Reduced wait time: Continuous access to solutions and
supplies, giving labs the ability to add tests and reagents without
pausing or stopping instruments or testing cycles for prolonged
periods of time.
- Simplified design for error proofing: Solution bottles
designed to work like a lock and key provide error proofing
benefits, ensuring the right solutions can only be inserted into
the right location and prevent costly mistakes in the lab
- Enhanced usability: Intuitive menu design and
easy-to-use interface, common to the Alinity family of instruments
across the lab, helps manage strained staffing resources.
The "Alinity c" clinical chemistry system, and the "Alinity i"
immunoassay system, can operate individually or as an integrated
Alinity ci-series unit, allowing for greater productivity in half
the footprint of current diagnostics systems. In addition to the
instrument clearance, several clinical chemistry and immunoassay
tests are now cleared in the U.S. for the system, with a
comprehensive menu of tests expected to be available within a year
of launch. The Alinity ci-series obtained CE Mark earlier this year
and is available in Europe,
Middle East, Asia and Latin
Americaii.
"Alinity ci was designed using a different approach. We went
beyond traditional market research and spent countless hours with
our customers, listening to their challenges and observing how they
work," said John Frels, Vice
President, Immunoassay and Clinical Chemistry Research and
Development. "With customer insights as our roadmap, the Alinity ci
is engineered to simplify diagnostic testing while ensuring speed,
accuracy and performance."
About Alinity
The Alinity portfolio includes clinical
chemistry, immunoassay, blood and plasma screening, point of care,
hematology and molecular diagnostics, along with Abbott's AlinIQ—a
first-of-its-kind, holistic suite of professional services that
combines expertise with process analysis and informatics. Alinity
is helping labs and hospital systems solve some of their most
pressing challenges to deliver better patient care with fewer
resources. More information is available at abbott.com/alinity.
About Abbott
At Abbott, we're committed to helping you
live your best possible life through the power of health. For more
than 125 years, we've brought new products and technologies to the
world -- in nutrition, diagnostics, medical devices and branded
generic pharmaceuticals -- that create more possibilities for more
people at all stages of life. Today, 94,000 of us are working to
help people live not just longer, but better, in the more than 150
countries we serve.
Connect with us at www.abbott.com, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal.
i Dependent upon clinical chemistry and immunoassay
test mix.
ii Instrument and test availability can vary by
geography.
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SOURCE Abbott