Recipient: Tepnel Diagnostics Inc.
Product:Elucigene genetic assays
Date: 8/26/05
FDA District: New England District OfficeBased on information on your website, these devices do not adhere to the restrictions on the sale, distribution, and use of ASRs. Your website makes specific analytical and performance claims such as that your devices can detect multiple mutations per device and screen for particular diseases. Statements on your website describing your devices indicate that they are intended for the detection of mutations related to a clinical diagnosis of, for example, Cystic Fibrosis, Tay Sachs Disease, and the risk for venous thromboembolism. In addition, the Instructions/Methods for Use supplied for your assays, provide detailed procedures (along with directions and guidelines for the interpretation of results) that are unique for your assays and that constitute analytical and performance claims. Furthermore, your CF-HT assay is marketed for use with your CF- HT Results Reporter software. Such software also, as described, does not meet the definition of an ASR.
A review of our records shows no clearance or approval for your gel-based ELUCIGENE genetic assays or your CF-HT Results Reporter software. These devices are therefore adulterated under section 501(f)(1)(B) of the Act because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, or an approved application for investigational device exemption (IDE) under section 520(g) of the Act These devices are also misbranded under section 502(o), because you did not notify the agency of your intent to introduce the device into commercial distribution as required by section 510(k). For a product requiring premarket approval before marketing, the notification required by section 510(k) of the Act is deemed to be satisfied when a PMA is pending before the agency. 21 CFR 807.81(b).
Issuer:Center for Devices and Radiological Health (CDRH)
