(115 days)
The UREA reagent (BUN) is to be used to aid in the determination of liver and kidney functions and congestive heart failure and other diseases associated with protein catabolism.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device named "UREA reagent (BUN)". This document is a regulatory approval and does not contain details about acceptance criteria or a study that proves the device meets specific performance criteria.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices and outlines general regulatory information, but it does not describe clinical or performance study results.
Therefore, I cannot provide the requested information based on the provided text.
§ 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.