| bioMérieux
INDUSTRY Announces U.S. FDA 510(k) Clearance for New Plastic BacT/ALERT®
BPA and BacT/ALERT BPN Culture Bottles
December 17, 2003 – bioMérieux®
INDUSTRY announces United States Food and Drug Administration
Center for Biologics Evaluation and Research (FDA-CBER) 510(k)
clearance1 of new, innovative plastic BacT/ALERT®
BPA and BacT/ALERT BPN culture bottles for microbial quality control
testing of leucocyte-reduced apheresis platelets (LRAPs).
The plastic BacT/ALERT BPA and BacT/ALERT BPN culture bottles
are dedicated for use on the BacT/ALERT Microbial Detection Systems
for microbial quality control testing of LRAPs. BacT/ALERT BPA
culture bottles support the growth of aerobic microorganisms and
BacT/ALERT BPN culture bottles support the growth of anaerobic
and facultative anaerobic microorganisms. Through extensive, external
clinical trials, the plastic bottles have demonstrated equivalent
performance to the currently marketed glass BacT/ALERT SA and
BacT/ALERT SN culture bottles. bioMérieux has incorporated
an additional internal 100% quality control inspection of each
individual culture bottle following a retention period to ensure
strict quality control measures are maintained. The introduction
of this new culture media will also allow bioMérieux to
improve tracking of the field performance of bacterial contamination
quality control testing of LRAPs.
The upcoming commercialization of these innovative shatter break
resistant plastic BacT/ALERT bottles will significantly impact
the world of culturing by reducing the risks of accidental injury
among laboratory staff. The multi-layer plastic used to produce
these bottles does not alter the system’s detection performance;
furthermore, the plastic bottles are 58 % lighter than the glass
bottles currently used on the BacT/ALERT system, resulting in
easier handling and more cost effective disposal. The bottles
do not contain heavy metals and can be disposed safely, without
polluting the environment.
In 2004, bioMérieux anticipates launching an innovative,
software package: BacT/Notify™. The software package will
enable the laboratories to broadcast positive results to remote
distribution locations. More important, the software enables an
authorized person in a remote location (e.g. a hospital) to have
access to the latest available BacT/ALERT BPA and BacT/ALERT BPN
quality control result. This unique feature will unite the functions
of sampling and quality control testing of LRAPs to delivery of
the latest available result.
Automation in the field of culturing plays a significant role
in improving laboratory workflows and quality control through
continuous monitoring and rapid results. The automated BacT/ALERT
system provides the blood bank industry with a reliable, state-of-the-art
quality control technology for testing of LRAPs. The system demonstrates
sensitivity and specificity at detecting bacteria for quality
control testing as low as 4 CFU/ml with detection times generally
shorter than 24 hours2.
Through continuous innovation, the BacT/ALERT product range offers
high-performance technology and easy-to-use design to laboratories,
large or small, worldwide. bioMérieux is the world leader
in the automated blood culture market and is committed to a long-term
partnership to further improve quality control testing of leucocyte-reduced
apheresis platelets.
About bioMérieux INDUSTRY
bioMérieux INDUSTRY provides product solutions to quality
control and research microbiology laboratories. Applications served
include environmental monitoring, sterility testing, pathogen
screening, quality indicators, microbial identification, quality
control organisms, microbial limits and preservative effectiveness
testing.
About bioMérieux
A global leader in disease prevention and management, bioMérieux
provides assays, reagents and instrumentation for clinical microbiology,
coagulation, immunoassay, and nucleic acid diagnostics; and also
for product quality control in the agri-food, cosmetics and pharmaceutical
industries. Based in Marcy-l’Etoile, France, the company’s
U.S. headquarters is in Durham, North Carolina.
With sales of 1 billion Euros in 2002, bioMérieux ranks
as the eighth-largest biological diagnostics company worldwide.
Over 81% of its activity takes place on an international level.
Investment in research and development represents 13% of sales.
bioMérieux employs 5400 people throughout the world, including
3200 in Europe and 1500 in the U.S. The group has 15 production
sites located in France, the United States, Brazil, Italy and
the Netherlands, as well as a European logistics center in France.
Already present in over 130 countries, with more than 110 distributors
and 32 subsidiaries, bioMérieux continues its international
development by strengthening its presence in Latin America and
Asia.
References:
1 http://www.fda.gov/cber/whatsnew.htm
2 Brecher ME., Heath DG., Hay SN., Rothenberg SJ.,
Stutzman LC., Evaluation of a new generation of culture bottle
using an automated bacterial culture system for detecting nine
common contaminating organisms found in platelet components. Transfusion
2002;42:774-779
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