(289 days)
Activated Aspartate Aminotransferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate aminotransferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
Abbott Laboratories Activated AST is an in vitro diagnostic assay for the quantitation of aspartate aminotransferase (also known as serum glutamic oxaloacetic transferase or SGOT) in human serum or plasma. The Abbott Laboratories Activated AST assay is a clinical chemistry assay in which the aspartate aminotransferase catalyzes the transfer of the amino group from L-aspartate to a-ketoglutarate, in the presence of pyridoxal-5'phosphate, forming oxaloacetate and L-glutamate. Oxaloacetate in the presence of NADH and malate dehydrogenase (MDH) is reduced to L-malate. In this reaction, the NADH is concomitantly oxidized to NAD. The reaction is monitored by measuring the rate of decrease in absorbance at 340 nm due to the oxidation of NADH to NAD.
Here's an analysis of the provided text regarding the Abbott Laboratories Activated AST assay, structured to address your specific points:
Since this document describes a diagnostic assay and not an AI/ML device, many of the requested points related to AI/ML specific studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance) are not applicable. The study design described is a comparative performance study against a predicate device, which is standard for in vitro diagnostic (IVD) assays for 510(k) clearance.
Acceptance Criteria and Study Summary for Abbott Laboratories Activated AST Assay
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are implicitly defined by the demonstration of comparable performance to the predicate device, specifically in terms of correlation (regression analysis) and precision.
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance (New Device vs. Predicate) |
|---|---|---|
| Method Comparison (Correlation Coefficient) | High correlation (e.g., >0.97, common for IVD) with predicate device. | - Abbott AEROSET: 0.999 (slope 1.06, Y-intercept 3.79 U/L) |
- ARCHITECT c8000: 0.999 (slope 1.01, Y-intercept -4.15 U/L)
- ARCHITECT c16000: 0.999 (slope 1.03, Y-intercept -3.75 U/L) |
| Precision (Total %CV) | Acceptable within-laboratory precision for different AST levels (typically varies by concentration). | ARCHITECT c8000: - Level 1 (43 U/L): 4.5% (20 Day)
- Level 2 (192 U/L): 1.0% (20 Day)
- Level 3 (23 U/L): 2.4% (5 Day)
- Level 4 (3,437 U/L): 0.7% (5 Day)
AEROSET System: - Level 1 (46 U/L): 2.3% (5 Day)
- Level 2 (205 U/L): 0.7% (5 Day)
ARCHITECT c16000 System: - Level 1 (45 U/L): 1.8% (5 Day)
- Level 2 (197 U/L): 0.5% (5 Day) |
| Linearity | Demonstrate accuracy across a clinically relevant range. | Linear up to 1,985 U/L. |
| Limit of Quantitation (LoQ) | Define the lowest concentration that can be accurately measured. | 5 U/L (with Flex Rate linearity up to 5,364 U/L). |
The study demonstrates that the Abbott Laboratories Activated AST assay on various Abbott platforms (AEROSET, ARCHITECT c8000, ARCHITECT c16000) achieves a very high correlation (0.999) with the predicate device (Abbott AST Activated, K981221) on the AEROSET System. The reported precision (total %CV) values are varied but generally low, indicating good reproducibility. The linearity and limit of quantitation also support the device's performance across its intended measuring range.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the number of samples used for the method comparison (correlation) or precision studies. It mentions "Comparative performance studies were conducted" and "Precision studies were conducted," providing the results without specific sample counts for each.
- Data Provenance: The document does not specify the country of origin of the data. Given the "Abbott Laboratories" submitter in Irving, TX, USA, it is highly probable the studies were conducted in the USA. The studies are prospective in nature, as they involve running samples on the new device and comparing them to a predicate device, which implies collecting or generating data for the specific purpose of the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as this is an in vitro diagnostic assay, not an AI/ML device relying on human expert annotations for ground truth. The "ground truth" for this assay is the measurement obtained from the legally marketed predicate device, which itself would have undergone rigorous validation.
4. Adjudication Method for the Test Set
Not applicable for an in vitro diagnostic assay. Performance is assessed by direct comparison of numerical results to the predicate device and established analytical performance metrics (e.g., correlation, precision).
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 assay, not an AI/ML device for aiding human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
For an IVD, the "standalone" performance is essentially what is evaluated. The device itself (reagents + instrument system) performs the measurement. The results of the comparative performance studies and precision studies represent the standalone performance of the assay. There isn't an "algorithm only" in the sense of AI/ML, but rather the chemical reaction and photometric measurement by the instrument.
7. The Type of Ground Truth Used
The ground truth for demonstrating substantial equivalence is the performance of the legally marketed predicate device (Abbott AST Activated assay, K981221 on the Abbott AEROSET System). The goal is to show the new device yields "similar results" and "similar Performance Characteristics" to this predicate.
8. The Sample Size for the Training Set
Not applicable. This is an IVD assay, not an AI/ML device that requires a training set in that context. The "training" for such a system would involve method development and optimization, but not in the sense of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI/ML device. For an IVD, the initial method development and optimization would rely on established analytical chemistry principles and potentially reference methods, but this is distinct from establishing ground truth for machine learning.
§ 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.