Nucleic Acid Detection System for Non-Viral Microorganism(S) Causing Sexually Transmitted Infections

What Is It?

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.

What Is FDA Product Code QEP?

Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections is FDA product code QEP, Class 2, 21 CFR 866.3393.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Has Gone Wrong With It?

The FDA has recorded 4 recalls under this product code since 2023. None was by a company in China. The root causes the FDA records most often are Software design (2) and Device Design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.