FDA Product Code QEP: Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Rapid molecular identification of non-viral pathogens enables targeted antimicrobial therapy. FDA product code QEP covers nucleic acid detection systems for non-viral microorganisms including bacteria, fungi, and parasites.
These PCR-based or hybridization assays detect and identify pathogen-specific nucleic acid sequences from clinical specimens including blood, respiratory samples, and body fluids, providing results faster than conventional culture methods.
QEP devices are Class II medical devices, regulated under 21 CFR 866.3393 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Roche Molecular Systems, Inc., Becton, Dickinson and Company and Hologic, Inc..
FDA 510(k) Cleared Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections Devices (Product Code QEP)
About Product Code QEP - Regulatory Context
510(k) Submission Activity
21 total 510(k) submissions under product code QEP since 2019, with 20 receiving FDA clearance (average review time: 245 days).
Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.
FDA Review Time
FDA review times for QEP submissions have been consistent, averaging 258 days recently vs 242 days historically.
QEP devices are reviewed by the Microbiology panel. Browse all Microbiology devices →