(57 days)
The ATAC Direct HDL Cholesterol Reagent Kit and the ATAC HDL-C Calibrator are intended for the quantitative determination of high density lipoprotein cholesterol in serum on the ATAC 6000 Chemistry Analyzer. 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 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.
Acceptance Criteria and Device Performance for ATAC Direct HDL Cholesterol Reagent Kit and ATAC HDL-C Calibrator
The ATAC Direct HDL Cholesterol Reagent Kit and ATAC HDL-C Calibrator are intended for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum on the ATAC 6000 Chemistry Analyzer. HDL-C 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.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Linearity | Good correlation (r² close to 1) between standard recoveries and standard values across the measuring range. | r² = 0.999 for recoveries ranging from 1.4 to 174 mg/dL. Regression equation: (ATAC Recoveries) = 1.9 mg/dL + 1.074 x (Standard Value). sv.x = 1.62 mg/dL. |
| Precision | Low %CV for both within-run and total precision. | Within Run: |
- Serum 1 (mean 35.4 mg/dL): 1SD = 0.84, %CV = 2.4%
- Serum 2 (mean 45.1 mg/dL): 1SD = 0.89, %CV = 2.0%
Total: - Serum 1 (mean 32.7 mg/dL): 1SD = 2.47, %CV = 7.6%
- Serum 2 (mean 45.1 mg/dL): 1SD = 3.30, %CV = 7.3% |
| Method Comparison | Strong correlation with an accepted clinical method. | y = - 2.4 mg/dL + 1.077x (where y = ATAC 6000 results, x = accepted clinical method). Correlation coefficient (r) = 0.962. |
| Detection Limit | Claimed detection limit of 2 mg/dL should be met or exceeded by observed detection limit. | Observed detection limit = 1.3 mg/dL. This is below the claimed limit of 2 mg/dL, indicating the device meets the criterion. |
2. Sample Sizes and Data Provenance
- Test Set (Method Comparison): 131 serum specimens.
- Data Provenance: The specimens were collected from adult patients. The country of origin is not explicitly stated, but the submission is from Elan Diagnostics in Brea, California, USA, suggesting the data is likely from the USA. The study design appears to be prospective due to the nature of comparing a new device against an existing method using collected specimens, though the exact timing of collection relative to the study is not specified in detail.
- Test Set (Linearity): 8 linearity standards.
- Test Set (Precision - Within Run): 22 replicates for each of 2 control sera.
- Test Set (Precision - Total): 40 replicates for each of 2 control sera.
- Test Set (Detection Limit): 22 replicates of a diluted HDL-C control.
3. Number of Experts and Qualifications for Ground Truth
Not applicable for this type of in vitro diagnostic device study. The ground truth for chemical analytes like HDL-C is established through reference methods or precisely prepared standards, not typically through human expert consensus in the same way an imaging or clinical diagnostic algorithm would be.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth for these studies relies on analytical measurements rather than expert human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging or interpretation tasks where human readers' performance is being evaluated and potentially enhanced by AI. This submission is for an in vitro diagnostic reagent kit.
6. Standalone Performance Study
Yes, the studies described represent the standalone performance of the ATAC Direct HDL Cholesterol Reagent Kit and ATAC HDL-C Calibrator when used on the ATAC 6000 Chemistry Analyzer. The reported linearity, precision, and detection limit are intrinsic performance characteristics of the assay and the analyzer system. The method comparison study also evaluates the algorithm (reagent kit + analyzer) performance against an established clinical method.
7. Type of Ground Truth Used
- Linearity: Based on "standard values" of linearity standards, which are known, precise concentrations.
- Precision: Based on the measured values of "commercially available control sera" at different concentration levels, where the 'true' value is often derived from extensive inter-laboratory studies or established reference values.
- Method Comparison: The "accepted clinical method" serves as the reference or 'gold standard' for comparison.
- Detection Limit: Derived from repetitive assay of a "diluted HDL-C control" with a known low concentration.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" in the context of an algorithm or machine learning model. This is an in vitro diagnostic (IVD) reagent kit, where the "training" is more akin to assay development and optimization rather than machine learning. The studies described are performance studies demonstrating the final product's characteristics.
9. How the Ground Truth for the Training Set was Established
As noted above, a distinct "training set" with ground truth in the conventional machine learning sense is not applicable here. The development and optimization of the reagent kit would involve formulating the reagent to achieve specific chemical reactions and analytical performance characteristics, which is guided by established chemical principles and perhaps empirical testing against known standards and samples, rather than a formal machine learning training process with a labeled dataset.
§ 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.