Enzyme Immunoassay, Opiates

How Is DJG Classified?

Enzyme Immunoassay, Opiates is FDA product code DJG, Class 2, 21 CFR 862.3650.

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 15 clearances under this code; the FDA took a median of 134 days from receipt to decision on them.

2 went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Has Gone Wrong With It?

The FDA has recorded 13 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Material/Component Contamination (2), No Marketing Application (2) and Packaging (1).

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