U.S. FDA Premarket Notification 510(k) Clearance of Polycarbonate BacT/ALERT® Culture Bottles for Microbial QC Testing of Leukocyte-Reduced Single Units of Whole Blood Platelet Concentrates (WBPC)

U.S. FDA Premarket Notification 510(k) Clearance of Polycarbonate BacT/ALERT® Culture Bottles for Microbial QC Testing of Leukocyte-Reduced Single Units of Whole Blood Platelet Concentrates (WBPC)

Marcy-l’Etoile, France - March 26, 2004. bioMérieux announces U.S. FDA-CBER (1) Premarket Notification 510(k) clearance of the recently launched, innovative polycarbonate BacT/ALERT BPA and BacT/ALERT BPN culture bottles for microbial quality control testing of leukocyte-reduced single units of whole blood platelet concentrates (WBPC).

The bioMérieux polycarbonate BacT/ALERT BPA and BacT/ALERT BPN culture bottles can now be used for bacterial detection in platelet products derived from both apheresis collection procedures and single unit whole blood platelet concentrate collection procedures.

The polycarbonate BacT/ALERT BPA and BacT/ALERT BPN culture bottles are dedicated for use by the blood collection and transfusion industry on BacT/ALERT Microbial Detection Systems for platelet testing. 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 polycarbonate bottles have demonstrated equivalent performance to the formerly marketed glass BacT/ALERT SA and BacT/ALERT SN culture bottles, while greatly improving safety.

The multi-layer polycarbonate used to produce these bottles does not alter the system’s detection performance; furthermore, the polycarbonate bottles are 30 % 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.

bioMérieux has incorporated an extensive quality control inspection for the BacT/ALERT BPA and BacT/ALERT BPN culture bottles. This blood bank specific product will also allow bioMérieux to improve tracking of the field performance of bacterial contamination testing of blood products. The BacT/ALERT automated culture system is in routine use by blood collection and transfusion facilities in over 25 countries worldwide and has a proven track record of 12 years for testing blood products.

References:

• United States Food and Drug Administration Center for Biologics Evaluation and Research (see www.fda.gov/cber/whatsnew.htm).