General Purpose Reagent

What Is This Device?

A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.

What Is FDA Product Code PPM?

General Purpose Reagent is FDA product code PPM, Class 1, 21 CFR 864.4010.

How Does It Reach the US Market?

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. It is also exempt from most of the quality system regulation.

What Has Gone Wrong With It?

The FDA has recorded 30 recalls under this product code since 2016. None was by a company in China. 8 are Class I, the most serious grade.

The root causes the FDA records most often are Nonconforming Material/Component (6), Process control (4) and Error in labeling (2). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.