Lyme Disease

FDA clearance granted for Lyme test kit

Published in Medical Letter on the CDC and FDA, January 11th, 2004

Boston Biomedica, Inc., (BBII) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its BBI Borrelia burgdorferi IgM and IgG Western Blot Test Kit.

The test method separately detects IgM and IgG antibodies to B. burgdorferi, the infectious tick borne bacteria that cause Lyme disease. The FDA's 510(k) clearance allows the test to be marketed and sold in the U.S. with the label for in vitro diagnostic use.

The BBI Borrelia burgdorferi IgM and IgG Western Blot Test Kit is intended for use in testing human serum samples that have been found positive or equivocal using a first-line test...

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Source: Medical Letter on the CDC and FDA (2004-01-11)

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