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Binax Now® Malaria Test - K061542

This is a brief overview of information related to FDA’s to FDA’s approval of an Evaluation of Automatic Class III Designation to market this device.

Product Name: Binax Now® Malaria Test
Manufacturer: Binax, Inc., a subsidiary of Inverness Medical Innovations, Inc.
Address: 10 Southgate Road, Suite 170, Scarborough, ME 04074
Approval Date: June 13, 2007 (Approved Evaluation of Automatic Class III Designation)
Approval Letter: http://www.fda.gov/cdrh/pdf6/k061542.pdf

What is it? The Binax Now® Malaria Test is a rapid laboratory antigen test that can detect plasmodium parasites using a whole blood sample drawn from a vein or obtained by a finger stick. This is the first FDA product cleared for detection and identification of the parasites that cause malaria. It represents an important new tool for diagnosing malaria in parts of the world that do not have qualified personnel to read microscopic smears.

How does it work?

• The patient’s blood sample is applied to the sample pad. If malaria antigens are present they bind to anti-malaria antibodies.
• A liquid reagent is then added to the pad allowing the antigen-antibody complexes to migrate along the test strip where they are captured by immobilized antibodies forming two test lines. A third line is formed (control line) if all of the reagents are working and migrating properly.
• The test lines are positive if both or one of the test lines and control lines turn a pink to purple color. The test is negative if only the control line shows a pink-purplish color.

When is it used? The Binax Now® Malaria Test is used for testing individuals showing signs and symptoms of malaria in areas of the world that are endemic for malaria or in individuals returning from travel to or residence in endemic areas.

What will it accomplish? The test can differentiate the more serious malaria parasite (Plasmodium falciparum) from the other three plasmodium species that can infect humans. The test result can be used to initiate empiric therapy if the patient has signs and symptoms of malaria.

When should it not be used? The Binax Now® Malaria Test should not be used for malaria screening or in individuals that have no signs or symptoms of malaria or for monitoring anti-malaria therapy. Negative tests result should be confirmed by the more sensitive microscopy thin- and thick-film blood smears.

Additional information: 510(k) Decision Summary and labeling will be available at: http://www.fda.gov/cdrh/pdf6/k061542.pdf

Updated August 21, 2007

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