Kit, Test, Pregnancy, Hcg, Over the Counter

What Is FDA Product Code LCX?

Kit, Test, Pregnancy, Hcg, Over The Counter is FDA product code LCX, Class 2, 21 CFR 862.1155.

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 28 clearances under this code; the FDA took a median of 142 days from receipt to decision on them.

One 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 25 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Storage (8), No Marketing Application (2) and PMA (1).

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