Test, Tricyclic Antidepressants, Over the Counter

What Is This Device?

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

How Is QAW Classified?

Test, Tricyclic Antidepressants, Over The Counter is FDA product code QAW, Class 2, 21 CFR 862.3910.

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. No clearance under this code names a Chinese applicant.

A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.