(21 days)
Total Bilirubin is intended for the quantitative determination of total bilirubin in serum using Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
Total Bilirubin Reagent
This document is a 510(k) clearance letter from the FDA for a Total Bilirubin Reagent. This type of document does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..."
This means the device's performance was compared to a predicate device already on the market, and the FDA determined it was substantially equivalent, allowing it to be marketed. The detailed study results, acceptance criteria, sample sizes, and ground truth information are typically found in the 510(k) submission itself, which is a much larger document and not provided here.
Therefore, I cannot provide the requested information from this document.
§ 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.