Real Time Nucleic Acid Amplification System

What Is This Device?

The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit.

The system is used with specific assays to comprise an assay test system.

What Is FDA Product Code OOI?

Real Time Nucleic Acid Amplification System is FDA product code OOI, Class 2, 21 CFR 862.2570.

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

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 30 recalls under this product code since 2010. None was by a company in China. The root causes the FDA records most often are Device Design (5), Software design (4) and Nonconforming Material/Component (4).

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