SAN DIEGO, CA -- (MARKET WIRE) -- 12/27/2005 -- Cell Bio-Systems, Inc. (OTC: CBSI) a developer of medical devices and patented technologies for the plastic, cosmetic, orthopedic, and living tissue markets, today announced it has passed three of four tests for biocompatibility in its process of gaining FDA clearance for distribution of its disposable surgical instruments.
Independent testing was conducted by NAMSA (North American Science Associates, Inc.) on the multi-port harvester. Tests included a cytotoxicity study on the in vitro biocompatibility of the metal tip, hydrophilic coating, plastic hub and assembly used, an ISO intracutaneous study, and a USP and ISO systemic toxicity study. The instrument components performed well in all three tests.
Although the components used in these disposable instruments have all previously passed class 6 requirements individually, they must be tested as an assembly to satisfy the FDA biocompatibility requirements. In the testing process, the reagent control, negative control and positive control all performed as anticipated. The study was conducted in accordance with the provisions of the FDA Good Laboratory Practice Regulations, 21 CFR 58. A Certificate of Quality Assurance Inspections was issued with the test results.
In order to receive FDA clearance for CBSI to distribute its disposable surgical instruments, CBSI must meet several requirements: completion of the full biocompatibility four test series, completion of sterilization validation testing, and the submission and clearance of the Premarket Notification (510K).
Marc Pilkington, chief executive officer of CBSI, said, "With these test approvals, we are right on target for our FDA 510K approval process. Only two more tests remain, the sensitization study and sterilization validation; we are confident we will pass those equally well. We are very pleased with the results and think this bodes well for our general release schedule."
For over 35 years, NAMSA has been one of the world's leading companies specializing in the safety evaluation of medical devices. NAMSA offers testing services and products to medical device manufacturers, raw material suppliers, pharmaceutical companies, sterilizers and other related industries.
