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Clinical Chemistry 47: 1743-a, 2001;
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(Clinical Chemistry. 2001;47:1743.)
© 2001 American Association for Clinical Chemistry, Inc.

Letters

High-Sensitivity C-Reactive Protein: Product Claims and the Food and Drug Administration

Rebecca S. Ayash1a

1 Regulatory Affairs Hemostasis and Plasma Proteins Dade Behring Inc. PO Box 6101 MS 514 Newark, DE 19714-6101

aFax 302-631-6299 E-mail ayashrs{at}dadebehring.com


To the Editor:

Several articles in recent issues of Clinical Chemistry have made reference to the Dade Behring N High Sensitivity CRP (hs-CRP) assay and have indicated that it has been approved by the Food and Drug Administration (FDA) for cardiovascular risk prediction (1)(2)(3).

Although the use of hs-CRP assays in the assessment of cardiovascular risk is clearly gaining momentum, the FDA-cleared intended use for these tests is not cardiovascular risk prediction, but rather the quantitative determination of C-reactive protein (CRP) in serum and plasma. Measurements are useful in the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases. The Summary and Explanation section of the FDA-cleared labeling for the Dade Behring hs-CRP assay states that the test may add to the predictive value of other markers used to assess the risk of cardiovascular and peripheral vascular disease (4). I am unaware of any CRP assay being cleared by the FDA for stand-alone use to predict risk of cardiovascular disease.

As a class II in vitro diagnostic medical device, the Dade Behring N High Sensitivity CRP assay referenced in these articles is not "approved" by the FDA per se, nor is premarket approval required. Instead, as with most in vitro diagnostic tests, marketing clearance for the N High Sensitivity CRP assay was obtained by way of the premarket notification process described in section 510(k) of the Food Drug and Cosmetic Act. This distinction is important to manufacturers inasmuch as FDA regulations state that, "any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding" (5). To prevent publication of misleading information, I urge the Clinical Chemistry editorial staff to exercise specific caution in working with authors to appropriately identify the regulatory status of in vitro diagnostic medical devices.


References

  1. Rifai N, Ridker P. Proposed cardiovascular risk assessment algorithm using high-sensitivity C-reactive protein and lipid screening. Clin Chem 2001;47:1-3.
  2. Rifai N, Ridker P. High-sensitivity C-reactive protein: a novel and promising marker of coronary heart disease. Clin Chem 2001;47:403-411.[Abstract/Free Full Text]
  3. Roberts W, Moulton L, Law T, Farrow G, Cooper-Anderson M, Savory J, Rifai N. Evaluation of nine automated high-sensitivity C-reactive protein methods: implications for clinical and epidemiological applications, Part 2. Clin Chem 2001;47:418-425.[Abstract/Free Full Text]
  4. Ridker PM, Glynn RJ, Hennekens CH. C-Reactive protein adds to the predictive value of total and HDL cholesterol in determining risk of first myocardial infarction. Circulation 1998;97:2007-2011.[Abstract/Free Full Text]
  5. . US Government. Misbranding by reference to premarket notification. Code of Federal Regulations Title 21, Section 807.97. Fed Regist 2000;Apr 1:73.




This Article
Right arrow Extract Freely available
Right arrow Full Text (PDF)
Right arrow Submit an electronic Letter to
the Editor about this paper
Right arrow Alert me when this article is cited
Right arrow Alert me when eLetters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrow reprints & permissions
Citing Articles
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Ayash, R. S.
Right arrow Search for Related Content
PubMed
Right arrow Articles by Ayash, R. S.
Related Collections
Right arrow Lipids, Lipoproteins, and Cardiovascular Risk Factors

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