American Association for Clinical Chemistry
Better health through laboratory medicine
June 2010 Clinical Laboratory News: News from the FDA


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June 2010: Volume 36, Number 6

Change Ahead for FDA's Medical Device Advisory Committees

FDA announced that it will make changes to the way that medical devices are reviewed for premarket approval in public hearings. The decision to make changes to the review format stems from the steady increase in the number of medical advisory panel meetings in recent years. From 2008 to 2009, the number of meetings increased from 10 to 17, and expectations for 2010 are even higher. FDA’s Center for Devices and Radiological Health (CDRH) has faced procedural challenges related to voting and information presentation because of the higher number of meetings. Changes include removal of approvability comments on presentations, and voting on safety and effectiveness of a device and a device’s risk versus benefit, instead of voting on approvability of premarket approval applications.

“By making this change in voting procedure, panel members will address key scientific issues during their discussions, which will be reflected in their votes,” said CDRH director Jeffrey Shuren, MD. “The change will allow panel members to address issues related to their area of expertise instead of regulatory issues that may be unfamiliar to them.” Voting will also be done by ballot, and not by a show of hands. The intention of the procedural changes is to open discussion with a focus on possible risks of approving a device as opposed to the prior standard of only looking at the benefits a device provides.

FDA Clears Sysmex's XT-4000i

FDA has cleared Sysmex America, Inc.’s XT-4000i Automated Hematology Analyzer. The company’s patented fluorescent flow cytometry and advanced cell counting methods are used to produce rapid results used in diagnosis and therapeutic monitoring. The system has 34 parameters such as immature granulocyte (IG), which detects and quantifies circulating IG to aid in identification of acute infection, inflammatory response, or myeloproliferative disorders. Other parameters include reticulocyte hemoglobin equivalent (RET-He) and a body fluid specific mode.

FDA Approves Chagas Screening Test for Donors

FDA has approved the Abbott Prism Chagas, a test that will screen blood, tissue, and organ donors for the parasite Trypanosoma cruzi (T. cruzi), the cause of Chagas disease , a parasitic infection that potentially can be fatal. The assay detects antibodies to T. cruzi, and can be used to test serum or plasma specimens of potential donors, as well as blood specimens from cadaveric donors. There are 300,000 people in the U. S. with Chagas disease, which is spread primarily by blood-sucking insects carrying the parasite, but can also be spread through blood transfusions, organ transplants, and from mother-to-child.

 501 (k) Clearance for Illumina's BeadXpress

Illumina, Inc. has received 510(k) market clearance from the FDA for its BeadXpress system for multiplex genetic analysis. The system includes Illumina’s BeadXpress Reader and Verascan software. The indications of use, as determined by the FDA, state that the system is intended for the simultaneous detection of multiple analytes in a DNA sample utilizing VeraCode holographic microbead technology.