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  1. In Vitro Diagnostics

Letter to Manufacturers of Troponin Assays Listed with the FDA

OIVD has sent the following letter to manufacturers of Troponin assays listed with FDA.

[Manufacturer address]

Dear [Contact name]:

Since first discovered many years ago, cardiac troponin has become increasingly valuable as a biomarker of myocardial infarction (MI). In 2007, the National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines1 and the Joint ESC/ACCF/AHA/WHF Task Force2 Guidelines recommended the use of cardiac troponin as a biomarker for the diagnosis of myocardial infarction (MI) when used in conjunction with clinical evidence of myocardial ischemia. These recommendations solidified troponin’s importance in MI diagnosis and triage; at the same time, they formalized an adjustment in the clinical cutoffs and changed the way troponin results were interpreted and used

Many troponin assays currently available and marketed in the United States obtained 510(k) clearance prior to these recommendations, and the clinical sensitivities, specificities, and predictive values were determined using outdated clinical cutoffs and diagnostic criteria. In addition, some cleared assays may not have adequate analytical performance characteristics to support the current manner in which troponin tests are used (e.g., may not be able to reliably detect low enough concentrations of troponin). Laboratories and clinicians using these troponin test results are not generally aware that the performance data listed in the device labeling is obsolete. This may, in certain cases, have the potential for serious adverse health consequences..

FDA’s mission is to protect and promote the public health. When critical devices are labeled with misleading information due to changing practice guidelines, and where actual clinical test performance in current clinical practice is not known, it becomes challenging, if not impossible, for FDA to carry out its mission. To enable labs, manufacturers, and the FDA to identify device errors and malfunctions, the data and labeling of these important devices must be modernized so that all who use them may use them safely.

To address these concerns while improving patient care, FDA has started working with troponin assay manufacturers to modernize the performance evaluation and regulatory review of these critical tests. Our main interest is to ensure that laboratories and clinicians are informed of the true performance of troponin assays to help in result interpretation and laboratory verification of performance parameters. This is particularly important for newer, more sensitive troponin tests which may render values that can be difficult to interpret if sufficient information is not available in the device labeling.

Your company has been identified as having listed troponin assay(s) with the FDA [product code MMI]. We recommend you contact us, via a Pre-IDE submission, to discuss our current thinking on appropriate clinical study protocols and additional information that may be necessary to modernize the labeling and claims for your device.

Though improvements in the evaluation and labeling of troponin tests are necessary, we support the current clinical practice guidelines and the way troponin tests are used. We look forward to working with all troponin test manufacturers to ensure that these tests, used as an aid to diagnose MI, are safe and effective for that purpose.

Sincerely yours,


Courtney C. Harper, Ph.D.
Division of Chemistry and Toxicology Devices
Center for Devices and Radiological Health

1 National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines: Clinical Characteristics and Utilization of Biochemical Markers in Acute Coronary Syndromes - Circulation 2007; 115, 356-375.

2 Universal Definition of Myocardial Infarction - Circulation 2007: 116, 2634-2653.

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