(40 days)
For the quantitative determination of urea in serum. For IN VITRO diagnostic use. The measurement of urea can be clinically useful in the diagnosis of kidney disfinction. Serum urea plays an important role in the discrimination between prerenal and postrenal azotemia.
Not Found
I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria, study details, or performance of the Urea-SL Assay device. The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to a predicate device and outlining regulatory information. It does not contain the specific technical or clinical study data requested.
§ 862.1770 Urea nitrogen test system.
(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.