Search Results

The cassette COBAS Integra Albumin Gen.2 (ALB2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the albumin concentration in human serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

The COBAS Integra Albumin Gen.2 is a colorimetric assay for the determination of albumin concentration in serum or plasma. At a pH value of 4.1, albumin displays a sufficiently cationic character to be able to bind with bromcresol green (BCG) to form a blue-green complex. The color intensity is directly proportional to the albumin concentration and can be determined photometrically.

The provided text is a 510(k) Summary for the COBAS Integra Albumin Gen.2. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, or comparative effectiveness studies. The document primarily focuses on regulatory approval and equivalence to a previously marketed device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

Ask a specific question about this device