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I. Introduction
FDA is issuing this draft guidance to provide industry and agency staff with recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices (IVDs) intended for the detection of antibodies to Borrelia burgdorferi. These devices are used to aid in the diagnosis of Lyme disease.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

II. Background
This document recommends studies for establishing the performance characteristics of in vitro diagnostic devices for the detection of antibodies to B. burgdorferi in human serum, plasma, and blood. Serological testing for antibodies to B. burgdorferi in Lyme disease diagnostics is a two step procedure [Ref. 1, 2]. Initial testing is done by an enzyme immunoassay (EIA) or immunofluorescent assay (IFA); specimens yielding positive or equivocal results are tested further by using a Western immunoblot assay. Specimens negative by a sensitive EIA or IFA do not need further testing. Results from Western blot assays for antibodies to B. burgdorferi are supplemental rather than confirmatory.
Two-step positive results provide supportive evidence of exposure to B. burgdorferi, which could support a clinical diagnosis of Lyme disease but should not be used as a sole criterion for diagnosis.
A manufacturer who intends to market an in vitro diagnostic device for detection of antibodies to B. burgdorferi must conform to the general controls of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and, unless exempt, obtain premarket clearance or approval prior to marketing the device (sections 510(k), 513, 515 of the FD&C Act; 21 U.S.C. 360(k), 360c, 360e). This document is intended to supplement 21 CFR 807.87 (information required in a premarket notification) and other FDA resources such as ``Premarket Notification 510(k)'' at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm. Guidance on the content and format for abbreviated and traditional 510(k)s is available in the guidance entitled ``Format for Traditional and Abbreviated 510(k)s'' found at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm084396.pdf

III. Scope
This document recommends studies for establishing the performance characteristics of EIA or Western blot devices for the detection of antibodies to B. burgdorferi in human serum, plasma, and blood. The following is the product code for B. burgdorferi (Lyme disease) Class II devices cleared under 21 CFR 866.3830:
LSR - Reagent, Borrelia Serological Reagent
This document does not apply to B. burgdorferi nucleic acid amplification assays. Please contact the Division of Microbiology Devices in the Office of In Vitro Diagnostic Device Evaluation and Safety for further information on nucleic acid amplification devices.

IV. Risks to Health
Lyme disease is a significant public health concern. It is the most common vector-borne infectious disease in North America. The infectious agent in Lyme disease is the spirochete B. burgdorferi. Definitive diagnosis of B. burgdorferi infection is complicated by the varied nature of the clinical symptoms and the overlap of these symptoms with numerous other infectious and non-infectious diseases.
Failure of devices for the detection of B. burgdorferi antibodies to perform as expected, or failure to correctly interpret results may lead to incorrect patient management decisions and inappropriate public health disease reporting. In the context of individual patient management, a false negative report could lead to a delay or failure to provide treatment. A false positive report could lead to unnecessary or inappropriate treatment.
Therefore, establishing the performance of these devices and understanding the risks that might be associated with their use is critical to their safe and effective use.
The studies conducted by manufacturers to establish the performance of B. burgdorferi antibody detection devices are the basis for determining the safety and effectiveness and substantial equivalence of these devices.
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