Of Special Interest to Laboratorians/LabNet
MedSun: Newsletter #24, May 2008

FDA's Office of In Vitro Diagnostics has approved the following new devices for marketing:

Dako TOP2A FISH pharmDx Kit is a laboratory test used to help a doctor assess the likely clinical course for certain patients with breast cancer. The test uses fluorescent DNA probes to measure the number of copies of the TOP2A (Topoisomerase 2 alpha) gene on chromosome 17 in breast cancer cells. The TOP2A gene plays a role in cell division. Changes in the number of copies of TOP2A gene indicate an elevated risk of post-surgical recurrence of the breast cancer or decreased long term survival.

FreeStyle Navigator Continuous Glucose Monitoring System is a glucose sensor that reports glucose values continuously for up to 120 hours. These readings are used with fingerstick results to detect trends and patterns in glucose levels in adults, age 18 and over, with diabetes.

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To see additional In Vitro Diagnostic Devices recently cleared for marketing visit:
http://www.fda.gov/cdrh/oivd/

Click under the left hand column "Quick Links" on the link "New OIVD products"

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FDA's Office of In Vitro Diagnostics Device Recalls, a searchable database of devices recently recalled by FDA's Office of In Vitro Diagnostics can be found at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/IVDRes.cfm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun