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New Device Clearance

Glucatell™ - K032373

This is a brief overview of information related to FDA’s clearance to market this product. 

Product Name: Glucatell™
Manufacturer: Associates of Cape Cod Inc.
Address: 704 Main Street, Falmouth, MA 02540
Clearance Date: May 21, 2004
Clearance Letter: http://www.fda.gov/cdrh/pdf3/k032373.pdf

What is it? Glucatell™ is a blood test, used in a medical laboratory or hospital, to help diagnose severe fungal infections.

How does it work? In fungal infections, part of the fungus wall (Beta-glucan) is shed into the blood. The Glucatell™ test kit tests for Beta-glucan in the blood. If it detects Beta-glucan, the patient may have a fungal infection.

In this test, a health care professional uses a needle to draw a small blood sample from a patient’s arm. The clear portion of the blood (the serum) is placed in a test chamber, and chemicals are added that change color if Beta-glucan is present.

When is it used? The test is used to help diagnose fungal infections when patients have symptoms of an infection, or if they have conditions that increase the risk of fungal infections (such as cancer, AIDS, or organ transplants).

What will it accomplish? This test helps doctors determine quickly whether or not a patient has a fungal infection. If test results are positive, doctors can perform other tests to determine what type of fungus is causing the infection.

What will it NOT accomplish? This test will not diagnose infections from types of fungus that do not produce Beta-glucan.

When should it not be used? The test should be used only with materials and chemicals (reagents) that are certified to be free of glucan.

Patients who do not have fungal infections may have Beta-glucan in their blood if they:

Additional information:

Updated June 28, 2004

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