A new guideline titled, "Class II Special Controls Guideline: Dengue Virus Nucleic Acid Amplification Test Reagents" has recently been posted. This special controls document was developed to support the classification into class II (special controls) of dengue (DEN) virus (DENV) nucleic acid amplification test (NAAT) reagents. The DENV NAAT reagents are devices using procedures such as real-time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) methods that detect the DENV serotypes 1, 2, 3, or 4 from viral RNA in human serum and plasma from individuals who have signs and symptoms consistent with dengue (mild or severe). These devices consist of primers, probes, enzymes and controls for the amplification and detection of DENV serotypes 1, 2, 3, or 4 viral RNA. The device is intended for use in the diagnosis of patients in conjunction with other clinical and laboratory findings.
This guideline identifies measures that FDA believes will mitigate the risks to health associated with these devices and provide a reasonable assurance of safety and effectiveness. Following the effective date of a final rule reclassifying the device, firms submitting a 510(k) for a DENV NAAT reagents will need either to (1) comply with the particular mitigation measures set forth in the special controls guideline or (2) use alternative mitigation measures, but demonstrate to the Agency's satisfaction that those alternative measures identified by the firm will provide at least an equivalent assurance of safety and effectiveness.
To read the guideline, please see: http://www.fda.gov/downloads/
MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/UCM413361. pdf