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New Device Clearance

Elecsys® proBNP Immunoassay - K022516

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

Product Name: Elecsys® proBNP Immunoassay
Manufacturer: Roche Diagnostics
Address: 9115 Hague Rd., Indianapolis, IN 46250
Clearance Date: November 19, 2002
Clearance Letter: http://www.fda.gov/cdrh/pdf2/k022516.pdf

What is it? The product is a laboratory test that can aid in the diagnosis of congestive heart failure. This is the first fully automated test for detecting congestive heart failure.

How does it work? The test can detect a protein molecule (N-terminal pro-B-type natriuretic peptide or NT-proBNP, for short) in the blood that is secreted almost exclusively by the heart. A high amount of NT-proBNP in the blood indicates the presence of congestive heart failure and provides information about its severity. The higher the blood level of NT-proBNP, the more serious is the condition. (A drawing of the heart is located at: http://www.tmc.edu/thi/anatomy.html.)

When is it used? The test can be used for patients suspected of having congestive heart failure. The test can detect the disease in its early stages and allows physicians to differentiate between heart failure and lung disorders with similar symptoms.

What will it accomplish? Early detection of the disease enables the physician to begin treatment and improve the course of the illness. Heart failure is an important public health problem affecting 1-2 percent of the population of developed countries.

When should it not be used? This test is not intended for screening the general public, but for testing of individuals suspected of having congestive hart failure.

Additional information: Summary/Approval letter can be found at: http://www.fda.gov/cdrh/pdf2/k022516.pdf

Other:

• http://www.fda.gov/cdrh/ode/guidance/1072.html - Published as Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers, 11/30/00.
• http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01173.html - FDA Talk Paper: “FDA Clears New Automated Lab Test for Congestive Heart Failure,” 11/22/02
• http://www.nlm.nih.gov/medlineplus/heartdiseasesgeneral.html - Comprehensive and varied information (some Spanish); go to "More news on heart diseases(General)" and then to "Heart Failure"
• http://www.nlm.nih.gov/medlineplus/heartfailure.html - Information specific to congestive heart failure; go to "More news on heart failure"
• http://www.cfsan.fda.gov/~dms/wh-heart.html - Diet information and links to other government sites with heart information
• http://www.fda.gov/opacom/lowlit/hlyheart.pdf - Eating for a healthy heart; colorful presentation of important dietary information

Updated 1/15/03

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