Hemoglobin A1c Test System

What Is It?

Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.

What Is FDA Product Code PDJ?

Hemoglobin A1c Test System is FDA product code PDJ, Class 2, 21 CFR 862.1373.

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. Chinese applicants hold 3 clearances under this code; the FDA took a median of 269 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 9 recalls under this product code since 2016. None was by a company in China. The root causes the FDA records most often are Device Design (2), Process control (1) and Storage (1).

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