(68 days)
The WIENER LAB GOT (AST) UV test system is an I.V.D. device intended to be used in the quantitative determination of aspartate amino transferase (AST or GOT) in human serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
The principle is based on the following reaction system: GOT L-aspartate + 2-oxoglutarate -> oxaloacetate + L-glutamate MDH Oxalacetate + NADH + H+ -> I-Malate + NAD+ AST or GOT: Aspartate Amino transferase MDH: Malate Dehydrogenase
This document describes the 510(k) summary for the "WIENER LAB. GOT(AST) UV" test system, an in vitro diagnostic device for quantitative determination of aspartate amino transferase (AST/GOT) in human serum and plasma. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that proves the device meets specific acceptance criteria in the sense of a standalone performance study with predefined acceptance thresholds.
However, based on the provided text, we can extract information regarding what would constitute "acceptance" for this type of device in the context of a 510(k) submission, which is demonstrating substantial equivalence to a predicate device. The performance characteristics of the WIENER LAB. device are presented in comparison to the predicate device (RANDOX AST ASAT GOT OPT. test system) to show this equivalence.
Here's an attempt to structure the information based on your request, understanding that the "acceptance criteria" here are implicitly linked to the predicate device's performance and the demonstration of substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, "acceptance criteria" are often relative to the predicate device's performance. The WIENER LAB. GOT (AST) UV device is designed to be substantially equivalent to the RANDOX AST ASAT GOT OPT. test system. The table below compares key performance characteristics. The implicit acceptance criterion is that the WIENER LAB. device's performance characteristics are comparable or better than the predicate device, or within acceptable clinical limits.
| Performance Characteristic | Predicate Device (RANDOX AST ASAT GOT OPT.) | WIENER LAB. GOT (AST) UV Device Performance | Implicit Acceptance Condition |
|---|---|---|---|
| Intended Use | Quantitative determination of aspartate amino transferase in human serum and plasma. | Same | Substantially equivalent. |
| Test Principle | Kinetic method | Kinetic method (with detailed reaction system provided). | Substantially equivalent. |
| Essential Components | L-aspartate, NADH, MDH, LDH, 2-oxoglutarate | Same (components not explicitly listed for Wiener Lab but implied by reaction system). | Substantially equivalent. |
| Formula | Optimized according to IFCC | Optimized according to IFCC (implied). | Substantially equivalent. |
| Reagents | R1: L-aspartate - TRIS (Buffer); R2: NADH - MDH - LDH - 2-oxoglutarate | Same (implied). | Substantially equivalent. |
| Preparation of Working Reagent | Dissolution of R2 with R1 | Same (implied). | Substantially equivalent. |
| Instability or Deterioration of Reagents | Not specified | Reagent Blank Absorbance 1.800 | Specific criteria provided for Wiener Lab, indicating controlled stability. This is an improvement or clarification relative to the predicate. |
| Sample | Human serum, heparinized plasmas, or EDTA plasmas | Human serum or heparinized plasmas | Wiener Lab device has a slightly narrower acceptable sample range (omits EDTA plasma) but is still substantially equivalent for its stated use. |
| Working Temperature Range | 25 - 30 - 37°C | 25 - 30 - 37°C | Same. |
| Wavelength of Reading | 334 - 340 - 366 nm | 334 - 340 - 366 nm | Same. |
| Linearity | 279 U/l | 470 U/l | Wiener Lab device shows wider linearity, which is usually considered an improvement. |
| Minimum Detection Limit | No stated in insert | 1.2 U/l | Wiener Lab device provides a specific MDL, where the predicate did not, indicating a more thoroughly characterized device. |
| Expected Values (37°C) | Male: until 37 U/l; Female: until 31 U/l | Male: until 38 U/l; Female: until 32 U/l | Expected values are very close, demonstrating substantial equivalence in reference ranges. |
| Within-run Precision | No stated in insert | Normal Serum Control: CV = 4.4%; Abnormal Serum Control: CV = 1.3% | Wiener Lab device provides specific precision data, indicating robust performance. |
| Total Precision | No stated in insert | Normal Serum Control: CV = 4.9%; Abnormal Serum Control: CV = 1.6% | Wiener Lab device provides specific precision data, indicating robust performance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly specify a "test set" sample size or data provenance (country, retrospective/prospective) for a clinical validation study in the traditional sense. The data provided in the table are performance characteristics typically derived from analytical verification studies (e.g., linearity, precision, detection limit). These studies are generally conducted by the manufacturer as part of product development and validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is an in vitro diagnostic device for quantitative chemical measurement, not an AI or imaging device requiring expert interpretation for ground truth establishment. The ground truth for performance characteristics like precision and linearity comes from established laboratory methods and statistical analysis.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this involves quantitative chemical measurement, not expert adjudication of results.
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
Not applicable. This is an in vitro diagnostic device for chemical analysis, not an AI-assisted diagnostic tool for human readers/clinicians.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is a standalone diagnostic test system. Its performance characteristics (linearity, precision, detection limit) are measured directly from the assay without human interpretation in the results generation process. The "standalone" performance is the data presented in the table.
7. The Type of Ground Truth Used
The ground truth for the performance characteristics (linearity, precision, detection limit, expected values) is established through accepted analytical chemistry and laboratory standards. For instance:
- Linearity: Determined by testing known concentrations of analytes and assessing the correlation between measured and expected values.
- Precision: Determined by repeatedly measuring samples (e.g., control sera) and calculating statistical measures like Coefficient of Variation (CV).
- Expected Values: Established through studies of healthy populations using established reference methods.
8. The Sample Size for the Training Set
Not applicable. This document describes an in vitro diagnostic assay, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of device.
§ 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.