(37 days)
The Synermed® Direct Billirubin reagent is intended for use in the quantitative determination of conjugated (direct reacting) bilirubin in serum or plasma.
Not Found
I apologize, but the provided text from the FDA 510(k) letter for the Synermed IR750 Direct Bilirubin Reagent does not contain the requested information about acceptance criteria or a study proving the device meets them.
The document is purely an FDA clearance letter, confirming that the device is substantially equivalent to a predicate device and can be marketed. It does not detail the specific performance studies, their methodology, or the results that led to this clearance.
Therefore, I cannot provide the detailed table and study description you requested based on the given input.
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.