(122 days)
The Direct HDL assay is used for the quantitation of high-density lipoprotein cholesterol levels in human serum or plasma. Low Direct HDL measurements are used in the diagnosis and treatment of coronary artery disease.
Direct HDL is an in vitro diagnostic assay for the quantitative determination of high-density lipoprotein cholesterol in serum or plasma. The Direct HDL assay is a two reagent format and depends on the properties of a unique detergent. This detergent solubilizes only the HDL lipoprotein particles, thus releasing the HDL cholesterol to react with cholesterol esterase and cholesterol oxidase, in the presence of chromogens to produce color. In addition to selectively disrupting the HDL lipoprotein particles, this unique detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL, and chylomicron lipoproteins by adsorbing to their surfaces. A polyanion is contained in the first reagent to assist with complexing LDL, VLDL, and chylomicron lipoproteins, further enhancing the selectivity of the detergent and enzymes for HDL cholesterol.
This 510(k) submission describes the Direct HDL assay, an in vitro diagnostic assay for the quantitative determination of high-density lipoprotein cholesterol in serum or plasma.
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1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Method Comparison | Acceptable correlation with Boehringer Mannheim Direct HDL assay on Hitachi 717 Analyzer. (Specific R, Slope, Y-intercept values are not explicitly stated as acceptance criteria but are the values reported as meeting "acceptable correlation"). | Correlation coefficient = 0.9882 |
| Slope = 1.067 | ||
| Y-intercept = 0.372 mg/dL. These data demonstrate that the performance of the Direct HDL assay is substantially equivalent to the performance of the Boehringer Mannheim Direct HDL assay on the Hitachi 717 Analyzer. | ||
| Precision | Acceptable within-run, between-run, and between-day results. (Specific %CV targets are not explicitly stated as acceptance criteria). | Total %CV for Level 1/Panel 141 control: 4.6% |
| Total %CV for Level 2/Panel 142 control: 3.6% | ||
| Linearity | Demonstrate linearity up to a relevant clinical range. | Linear up to 180.0 mg/dL |
| Sensitivity (Limit of Quantitation) | Demonstrate an appropriate limit of quantitation for clinical use. | 8.0 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Comparative performance studies were conducted" and "Precision studies were conducted using the Direct HDL assay," but does not provide the number of samples or subjects used in these studies.
- Data Provenance: Not explicitly stated. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given it's an IVD device, the samples would likely be human serum or plasma.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- No. of Experts: Not applicable. This is an in vitro diagnostic assay that generates quantitative results. The "ground truth" for method comparison and precision studies is typically derived from the performance of a legally marketed predicate device (Boehringer Mannheim Direct HDL assay on the Hitachi 717 Analyzer) and established analytical control materials, respectively. Expert interpretation of images or clinical cases is not relevant for this type of device.
- Qualifications: Not applicable for this type of device study.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As this is an IVD assay providing quantitative values, there is no expert adjudication process in the traditional sense. The comparison is statistical against a predicate device or pre-defined analytical metrics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC study was not done. MRMC studies are typically performed for imaging or interpretation devices where human readers assess cases, often with and without AI assistance, to measure diagnostic accuracy and efficiency. This device is a quantitative chemical assay, not an imaging or interpretation aid.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, the entire study focuses on the standalone performance of the Direct HDL assay. Since it is an in vitro diagnostic assay, its performance is inherently "standalone" in that it produces a quantitative result without human intervention in the measurement process (though a human ultimately interprets the result in a clinical context). The studies evaluate the assay's analytical performance (correlation with a predicate, precision, linearity, sensitivity).
7. The Type of Ground Truth Used
- Type of Ground Truth:
- Method Comparison: The "ground truth" is established by the performance of the legally marketed Boehringer Mannheim Direct HDL assay on the Hitachi 717 Analyzer, which serves as the reference method.
- Precision and Linearity: The ground truth for these studies is typically established by using certified control materials or spiked samples with known concentrations, or by statistical analysis of repeat measurements. These are analytical benchmarks, not clinical ground truth like pathology or outcome data.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI-based device that requires a training set. It is a chemical assay with a defined reagent formulation and analytical method.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device. The assay's performance characteristics are inherent to its chemical and enzymatic design.
§ 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.