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The DBIL method is an in vitro diagnostic test for the quantitative measurement of direct (conjugated) bilirubin in human serum and plasma on the Dimension Vista™ System. Measurements of direct bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder disease.

Diazotized sulfanilic acid is formed by combining sodium nitrite and sulfanilic acid at low pH. The sample is diluted in 0.5M HCl. A blank reading is taken to eliminate interference from nonbilirubin pigments. Upon addition of the diazotized sulfanilic acid, the conjugated bilirubin is converted to diazo-bilirubin, a red chromophore which absorbs at 540 nm and is measured using a bichromatic (540, 700 nm) endpoint technique.

The provided text describes the 510(k) summary for the DBIL Flex® reagent cartridge, which is an in vitro diagnostic test for measuring direct (conjugated) bilirubin in human serum and plasma. The study presented is a comparison to a predicate device to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative sense as might be found for a clinical outcome. Instead, it presents performance characteristics of the new device and compares them to a predicate device, aiming to show "substantial equivalence." The "acceptance" can be inferred from the "Conclusion" statement: "The Dimension Vista™ DBIL Flex® reagent cartridge is substantially equivalent in principle and performance to the predicate product."

The key performance characteristics reported are:

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