(34 days)
The Aspartate Aminotransferase Activated assay is used for the quantitation of aspartate aminotransferase (also known as a serum glutamic oxaloacetic transferase or SGOT) in human serum or plasma. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
Aspartate Aminotransferase Activated is an in vitro diagnostic assay for the quantitative determination of aspartate aminotransferase in human serum or plasma. The Aspartate Aminotransferase Activated assay is a clinical chemistry assay in which the aspartate aminotransferase catalyzes the transamination of aspartate and ox-ketoglutarate to produce oxaloacetate and glutamate. Oxaloacetate is subsequently reduced to malate by malate dehydrogenase (MDH) with the concomitant oxidation of NADH to NAD. The rate of NADH oxidation is measured by 340 nm and is proportional to the AST activity of the sample. In addition, this reagent contains lactate dehydrogenase (LD) which consumes endogenous pyruvate during the first four minutes of the incubation period.
The provided text describes the acceptance criteria and the study for the "AST Activated" (Aspartate Aminotransferase Activated) assay. This device is an in vitro diagnostic assay for the quantitative determination of aspartate aminotransferase in human serum or plasma. It is deemed substantially equivalent to a previously marketed device.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by achieving "acceptable correlation" and demonstrating substantial equivalence to the predicate device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Correlation Coefficient | Sufficiently high correlation with predicate (>0.97 - typical for method comparisons in IVDs) | 0.9932 (against Abbott SPECTRUM Aspartate Aminotransferase Activated assay) |
| Slope | Close to 1.0 | 0.856 |
| Y-intercept | Close to 0 U/L | -8.749 U/L |
| Total %CV (Level 1) | Not explicitly stated (e.g., |
§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.
(a)
Identification. An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.