Radioimmunoassay, Thyroid-Stimulating Hormone

How Is JLW Classified?

Radioimmunoassay, Thyroid-Stimulating Hormone is FDA product code JLW, Class 2, 21 CFR 862.1690.

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 290 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 46 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Device Design (13), Nonconforming Material/Component (8) and Software design (4).

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