Perspective on the Evaluation of Molecular Diagnostic Tests

Class II devices are those for which general controls alone are insufficient to provide reasonable assurance of safety and effectiveness and for which sufficient information is available to establish special controls to provide this assurance. Special controls may include performance standards, postmarket surveillance, and guidance for analytical/clinical data. Examples of class II IVDs are automated differential cell counters, fetal hemoglobin test systems, sickle-cell tests, and Toxoplasma gondii serological reagents. 

Class III IVDs are those devices for which (1) general and special controls are insufficient to provide reasonable assurance of safety and effectiveness, (2) there 

Under the Medical Device Amendments of 1976, the FDA is responsible for premarket evaluation of all laboratory testing devices (in vitro diagnostics) intended to be commercially marketed in the United States. There are two major pathways for introducing a medical device into the marketplace the premarket notification [510(k) clearance] and the premarket approval (PMA). The purpose of the 510(k) is to establish that a device is substantially equivalent (SE) to a legally marketed (predicate) device. The purpose of the PMA evaluation process is to establish the intrinsic safety and effectiveness of a new device. Unless specifically exempt, a sponsor must have an approved PMA or cleared premarket notification [510(k)] by the FDA before a device may be legally marketed for IVD use (Fig. 1). 

Does the new device have the same intended use or indications for use  

New Analyte, Novel Matrix/ Novel Methodology/Technology 

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