System, Test, Blood Glucose, Over the Counter

How Is NBW Classified?

System, Test, Blood Glucose, Over The Counter is FDA product code NBW, Class 2, 21 CFR 862.1345.

How Does It Reach the US Market?

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. Chinese applicants hold 31 clearances under this code; the FDA took a median of 266 days from receipt to decision on them. 9 went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Do the Recalls Say?

The FDA has recorded 137 recalls under this product code since 2003. None was by a company in China. 20 are Class I, the most serious grade.

The root causes the FDA records most often are Process control (17), Device Design (13) and Material/Component Contamination (12). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.