(48 days)
The WIENER LAB. GOT (AST) UV AA Líquida test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of aspartate amino transferase (AST or GOT) in human serum and plasma on both manual and automated systems. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
Kinetic Method. The principle is based on the following reaction system: GOT (AST) L-aspartate + 2-oxoglutarate → Oxaloacetate + L-glutamate MDH Oxalacetate + NADH + H + → L-Malate + NAD + The rate of disappearance of NADH and the resulting decrease in absorbance at 340 nm is directly proportional to the activity of GOT (AST). AST or GOT: Aspartate Aminotransferase. MDH: Malate Dehydrogenase. NADH: Nicotinamide-Adenine Dinucleotide (Reduced) NAD + : Nicotinamide-Adenine Dinucleotide. H + : Proton.
The provided document describes the "Wiener lab. GOT (AST) UV AA Líquida" test system, a quantitative in vitro diagnostic device for determining aspartate aminotransferase (AST or GOT) in human serum and plasma. The device's performance is compared to a predicate device, "Wiener lab. GOT (AST) UV," to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device by comparing key performance characteristics. The "acceptance criteria" are implicitly set by matching or improving upon the performance of the predicate device.
| Performance Characteristic | Predicate Device (GOT (AST) UV) | New Device (GOT (AST) UV AA Líquida) | Acceptance Criteria Met? |
|---|---|---|---|
| Intended Use | Quantitative determination of Aspartate Aminotransferase in human serum and plasma. | Same | Yes |
| Test Principle | Kinetic Method, based on NADH disappearance. | Same | Yes |
| Reagents | Buffer: L-aspartate - TRIS. Substrate: NADH – MDH – LDH - 2-oxoglutarate. | Same core components, but reconfigured for "AA Líquida" (liquid ready-to-use). | Yes (Functional equivalence despite formulation difference) |
| Preparation of Working Reagent | Dissolution of Reagent with stated volume of Buffer. | Reagents may be used separately or as Monoreagent, mixing 4 parts Buffer and 1 part Substrate. | Yes (Improved convenience without altering fundamental reaction) |
| Wavelength of Reading | 334 - 340 - 366 nm | 340 nm | Yes (Within acceptable range, possibly optimized) |
| Linearity | 470 U/l | 700 U/l | Yes (Improved linearity) |
| Expected Values | Male: up to 38 U/l (37°C) Female: up to 32 U/l (37°C) | Same (Implicitly, as no change is indicated for fundamental biological range) | Yes |
| Within-run precision (Normal Level Serum) | CV = 4.4% | CV = 2.41% | Yes (Improved precision) |
| Within-run precision (High Level Serum) | CV = 1.3% | CV = 1.22% | Yes (Comparable/slightly improved precision) |
| Run-to-run precision (Normal Level Serum) | CV = 4.9% | CV = 2.26% | Yes (Improved precision) |
| Run-to-run precision (High Level Serum) | CV = 1.6% | CV = 2.16% | Yes (Comparable precision, slight increase but still within acceptable limits for a clinical assay, though not explicitly stated as 'improved') |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the precision and linearity studies. It only provides the results (e.g., CV values and linearity range). The provenance of the data (e.g., country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable in this context. This device is a quantitative diagnostic assay, not an imaging or interpretive diagnostic tool that requires expert human interpretation to establish ground truth for testing. The "ground truth" for linearity and precision studies would be derived from the known concentrations or activities of reference materials, or statistical analysis of repeated measurements, not expert consensus on individual cases.
4. Adjudication Method for the Test Set:
This is not applicable for the type of device and studies presented. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation of medical images or other data where consensus among experts is needed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable in the sense of an "algorithm only" performance. The device is a chemical reagent system. Its performance (precision, linearity) is inherently "standalone" in the context of the assay itself, as it measures a biochemical parameter directly. There is no human interpretative "loop" in the direct performance of the assay.
7. The Type of Ground Truth Used:
For linearity, the ground truth would be based on known concentrations or activities of control materials or serially diluted samples.
For precision, the ground truth is established statistically by repeated measurements on stable control materials or patient samples to assess the reproducibility of the assay.
8. The Sample Size for the Training Set:
The document does not specify a training set in the context of machine learning or AI. For a traditional in vitro diagnostic assay like this, there isn't a "training set" in that sense. The assay's parameters (reagent concentrations, reaction conditions) are developed through chemical and biochemical optimization, often involving many experiments, but not a formally defined "training set" of patient data as would be found in AI/ML development.
9. How the Ground Truth for the Training Set was Established:
As there is no "training set" in the context of AI/ML for this device, this question is not applicable. The "ground truth" for the development of reagent formulations and assay conditions would be based on established biochemical principles, analytical chemistry standards, and experimental results aimed at optimizing the reaction kinetics and stability.
§ 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.