This guidance is intended to provide device manufacturers and FDA staff with updated recommendations concerning 510(k) submissions for various types of assays for C-Reactive Protein (CRP). The document is a revision of “Guidance for Industry: In Vitro Diagnostic C-Reactive Protein Immunological Test System,” issued on July 20, 1998. It is updated to address issues associated with the development of hsCRP (high sensitivity CRP) and cCRP (cardiac CRP) assays. These types of CRP assays have significantly lower limits of detection, and functional sensitivities that may be used to support new clinical uses of CRP quantitation. This document now includes discussion of how you should support indications for use claims of cCRP “for the evaluation of patients with coronary disease and coronary syndromes” in premarket submissions, including how you should assess different ranges of measurement, based on indications for use. Additionally, we provide recommendations for limitations of CRP test interpretation based on the non-specific nature of CRP elevations in blood.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.