Radioimmunoassay, Tricyclic Antidepressant Drugs

What Is It?

Intended to measure any of the tricyclic antidepressant drugs in serum or urine.

What Is FDA Product Code LFG?

Radioimmunoassay, Tricyclic Antidepressant Drugs is FDA product code LFG, Class 2, 21 CFR 862.3910.

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 1 clearance under this code; the FDA took 93 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 2 recalls under this product code since 2003. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.