DeviceClearance

Product code QEP— Microbiology

Alinity m STI Assay

Classification name
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Device class
Class 2
Regulation
21 CFR 866.3393
Advisory panel
Microbiology
Total cleared
24
First cleared
Most recent

FDA classification definition

“A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data.”

— U.S. Food and Drug Administration, device classification record for product code QEP under 21 CFR 866.3393, via openFDA

Market context for product code QEP

FDA has cleared 24 devices under product code QEP between 2019 and 2026, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QEP

Recent clearances under product code QEP

Data sourced from openFDA. This site is unofficial and independent of the FDA.