(45 days)
The ATAC-PAK Direct HDL Cholesterol Reagent Kit, the ATAC HDL-C Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of high density in serum. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders, atherosclerosis and various liver and renal diseases, and as a tool to assess the risk of developing and managing the progression of cardiovascular disease. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
The ATAC-PAK Direct HDL Cholesterol Reagent Kit, the ATAC HDL-C Calibrator and the ATAC 8000 Random Access Chemistry System are used as a system for the quantitative analysis of high density lipoprotein cholesterol (HDL-C) in serum. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders and various liver and renal diseases, and as a tool to assess the risk of developing and managing the progression of cardiovascular disease. The ATAC-PAK Direct HDL Cholesterol Reagent determines HDL-cholesterol through the enzymatic action of cholesterol esterase, cholesterol oxidase and peroxidase after the selective removal non-HDL sources of cholesterol. The resulting increase in absorbance at 578 nm is proportional to the HDL cholesterol concentration in the sample.
Here's a breakdown of the acceptance criteria and study information for the ATAC-PAK Direct HDL Cholesterol Reagent Kit, ATAC HDL-C Calibrator, and ATAC 8000 Random Access Chemistry System:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Linearity/Recovery | Linear range of 1 mg/dL to 150 mg/dL | Linear from 1 mg/dL to 150 mg/dL. |
| Regression R² value close to 1.0 (indicating strong linearity) | (ATAC Recoveries) = 1.8 mg/dL + 0.981 x (Standard Value), r² = 0.999. | |
| Low standard error of the estimate (sy.x) | sy.x = 1.77 mg/dL. | |
| Precision (Within-Run) | Low variability in repeated measurements of control sera | Serum control 1: Mean 29.8 mg/dL, within-run SD 1.76 mg/dL. |
| Serum control 2: Mean 45.1 mg/dL, within-run SD 2.26 mg/dL. | ||
| Precision (Total) | Low overall variability in repeated measurements of control sera | Serum control 1: Mean 29.8 mg/dL, total SD 1.71 mg/dL. |
| Serum control 2: Mean 45.1 mg/dL, total SD 2.23 mg/dL. | ||
| Method Comparison | Strong correlation with an accepted clinical method | y = 3.2 mg/dL + 0.938x (y = ATAC 8000 results, x = accepted clinical method). Correlation coefficient r = 0.969. |
| Detection Limit | Claimed detection limit of 1 mg/dL (or less) | Claimed 1 mg/dL. Observed detection limit (2 standard deviations of 22 replicate within-run precision study) = 0.66 mg/dL, which is below the claimed limit. |
| Reagent Stability | 14-day on-board reagent stability | Documented through assay of serum controls; ranges of HDL-cholesterol recoveries over the test period were less than 8 mg/dL, indicating stability. |
| Calibration Stability | 14-day calibration stability | Documented through assay of serum controls; ranges of HDL-cholesterol recoveries over the test period were less than 8 mg/dL, indicating stability. |
2. Sample Size Used for the Test Set and Data Provenance
- Linearity/Recovery: Regression statistics were based on standard recoveries ranging from 0.6 to 155.5 mg/dL. The number of unique standards is not explicitly stated, but di = 8 is mentioned, which often refers to the degrees of freedom in a regression, suggesting at least 9 data points.
- Precision:
- Serum control 1: n = 40 (replicates)
- Serum control 2: n = 40 (replicates)
- Method Comparison: One hundred and thirty-eight (n = 138) serum specimens.
- Detection Limit: 22 replicates were used for the within-run precision study to calculate the observed detection limit.
- Reagent and Calibration Stability: Not explicitly stated, but involved assays of "serum controls over the claimed periods."
Data Provenance:
The data provenance is not explicitly stated in terms of country of origin. The specimens for method comparison were "collected from adult patients," suggesting the data is retrospective as samples would have been collected prior to the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable for this type of device. This device is an in-vitro diagnostic (IVD) quantitative assay, where the "ground truth" is typically established by comparing its results to a validated reference method or known concentrations of analytes (standards/calibrators). There are no human "experts" establishing qualitative ground truth for diagnostic images or interpretations.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this device is a quantitative assay, not one requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a standalone in-vitro diagnostic device, not an imaging device or medical AI intended for human reader assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are all standalone performance evaluations of the ATAC-PAK Direct HDL Cholesterol Reagent Kit and ATAC HDL-C Calibrator when used on the ATAC 8000 Random Access Chemistry System. The device performs the quantitative analysis automatically.
7. The Type of Ground Truth Used
- Linearity/Recovery: Known concentrations of linearity standards.
- Precision: Commercially available control sera with established target values.
- Method Comparison: Results from an "accepted clinical method" as the reference for comparison. While not explicitly defined, an "accepted clinical method" implies a well-established and validated laboratory method for HDL-C measurement.
- Detection Limit: A diluted HDL-C control and the statistical calculation based on its variability.
- Stability: Serum controls with known properties over time.
8. The Sample Size for the Training Set
Not applicable. This device is a chemical reagent kit and an associated analyzer, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" for such a system would involve method development and optimization by the manufacturer to achieve the stated performance specifications.
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 algorithm. The "ground truth" for the development of the reagent and system would have been established through extensive chemical and analytical testing against reference materials and methods during its design and optimization phases.
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.