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510(k) Data Aggregation
(20 days)
ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED)
The Aspartate Aminotransferase Activated is used for the quantitation of aspartate aminotransferase (also known as a serum glutamic oxaloacetic transferase or SGOT) in human serum and 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 Abbott Laboratories' AST Activated (Aspartate Aminotransferase Activated) assay is an in vitro diagnostic device for the quantitative determination of aspartate aminotransferase in human serum or plasma. The provided document is a 510(k) summary for this device, comparing it to an existing predicate device to establish substantial equivalence.
Here's the breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the new device (Abbott Aspartate Aminotransferase Activated) were implicitly defined by its ability to demonstrate "similar Performance Characteristics" and "acceptable correlation" when compared to the legally marketed predicate device (Boehringer Mannheim® Aspartate Aminotransferase Activated assay on the Hitachi® 717 Analyzer). The intent was to show that the new device performs at least as well as the predicate.
| Performance Characteristic | Acceptance Criteria (Implicit - based on predicate similarity) | Reported Device Performance (Abbott AST Activated) |
|---|---|---|
| Method Comparison | Acceptable correlation with predicate device | Correlation coefficient = 0.9983, slope = 0.838, Y-intercept = -0.764 U/L (vs. Boehringer Mannheim on Hitachi 717) |
| Precision (Total %CV) | Similar to predicate / Clinically acceptable | Level 1: 5.3% |
| Level 2: 2.4% | ||
| Linearity | Clinically appropriate range | Up to 410 U/L |
| Limit of Quantitation (Sensitivity) | Clinically appropriate minimum detection | 9 U/L |
| Assay Range | Minor difference from predicate acceptable | Acknowledged as a minor difference from predicate |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size used for the comparative performance studies. It states "Comparative performance studies were conducted..." but does not provide the number of samples.
- Data Provenance: The document does not explicitly state the country of origin of the data. It is a retrospective comparison against a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not relevant or applicable for an in vitro diagnostic assay like this. The "ground truth" for chemical assays is established by the performance of a recognized reference method or a legally marketed predicate device, not by expert consensus in the same way it would be for image interpretation.
4. Adjudication Method for the Test Set
Not applicable for this type of in vitro diagnostic device study. The comparison is quantitative, based on chemical measurements rather than subjective interpretation requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are typically used for imaging-based diagnostic devices where human readers interpret images. This device is a quantitative chemical assay.
6. Standalone Performance Study
Yes, a standalone study was performed. The "Performance Characteristics" section details the following standalone performance metrics for the Aspartate Aminotransferase Activated assay:
- Precision studies: Within-run, between-run, and between-day studies were performed.
- Linearity: Tested up to 410 U/L.
- Limit of quantitation (sensitivity): Determined as 9 U/L.
7. Type of Ground Truth Used
For the comparative performance study, the "ground truth" was established by the results obtained from the legally marketed predicate device, the Boehringer Mannheim Aspartate Aminotransferase Activated assay on the Hitachi 717 Analyzer. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices.
8. Sample Size for the Training Set
Not applicable. This device is a chemical assay, so there is no "training set" in the context of machine learning algorithms. The development of such an assay involves chemical and enzymatic optimization, not data-driven training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device. The assay development would involve established biochemical principles and experimental validation using reference materials and established methods.
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