Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

What Is It?

A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of group b streptococci from pre-partum and intra-partum women to establish colonization status.

What Is FDA Product Code NJR?

Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test is FDA product code NJR, Class 1, 21 CFR 866.3740.

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.

What Has Gone Wrong With It?

The FDA has recorded 11 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Process control (3), Component change control (2) and Software design (1).

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