(38 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Direct HDL device:
Acceptance Criteria and Device Performance Study for Direct HDL Assay
This submission describes the Abbott Laboratories' Direct HDL assay, an in vitro diagnostic for quantitative determination of high-density lipoprotein cholesterol. The study aims to demonstrate substantial equivalence to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Method Comparison | Good correlation (e.g., r > 0.95, slope near 1, small y-intercept) compared to predicate device | Correlation coefficient (r) = 0.9883, Slope = 1.041, Y-intercept = 0.118 mg/dL (vs. Boehringer Mannheim Direct HDL-Cholesterol assay on Hitachi 717 Analyzer) |
| Precision (Total %CV) | Within acceptable ranges for diagnostic assays | Level 1/Panel 109: 5.3% |
| Level 2/Panel 110: 3.3% | ||
| Linearity (Upper Limit) | At least comparable to predicate; clinically relevant range | Linear up to 309.6 mg/dL |
| Limit of Quantitation (Sensitivity) | Clinically relevant lower limit | 1.2 mg/dL |
Note: The document does not explicitly state pre-defined acceptance criteria values for r, slope, y-intercept, %CV, linearity, or sensitivity. These are inferred from standard practices for establishing substantial equivalence in diagnostic assays.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample size (number of patient samples) used for the comparative performance studies (method comparison, precision, linearity, sensitivity). It mentions "two levels of control material" for precision studies, but this refers to internal quality control, not patient samples for the test set.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This is an in vitro diagnostic assay for measuring a specific analyte (HDL cholesterol). As such, the "ground truth" is established by a reference method or a legally marketed predicate device, not by expert interpretation of images or clinical findings. Therefore, information regarding "number of experts" and their "qualifications" for establishing ground truth is not applicable in this context. The Boehringer Mannheim Direct HDL-Cholesterol assay on the Hitachi 717 Analyzer serves as the reference for comparison.
4. Adjudication Method for the Test Set
Not Applicable. As explained above, the ground truth is based on a quantitative chemical measurement by a reference assay, not on subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic imaging systems where human readers interpret medical images. This document describes an in vitro diagnostic assay, where the output is a quantitative chemical value, not an image requiring human interpretation for diagnosis. Therefore, an MRMC study was not performed and is not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, implicitly. This is a standalone diagnostic assay. The performance characteristics (method comparison, precision, linearity, sensitivity) described reflect the performance of the device itself (the "algorithm only" in a broader sense of an automated assay) without human intervention in the quantitative measurement process (beyond operating the instrument and interpreting the numerical result). The study compares the performance of the Abbott Direct HDL assay to another automated assay.
7. The Type of Ground Truth Used
The ground truth for the comparison study was based on measurements obtained from the Boehringer Mannheim Direct HDL-Cholesterol assay on the Hitachi 717 Analyzer, which is a legally marketed predicate device. This essentially uses an established, accepted diagnostic method as the reference standard.
8. The Sample Size for the Training Set
Not applicable/Not specified. For a commercially available assay like this, typically the "training" phase refers to the assay development and optimization itself. There is no explicit mention of a "training set" in the context of machine learning, as this is a chemical assay, not an AI or machine learning algorithm in the modern sense. If prior studies or method development involved a "training" equivalent, the details are not provided in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not specified. As mentioned above, the concept of a "training set" and its associated ground truth establishment is not directly relevant to this type of chemical assay as it would be for a machine learning model. The development of the assay itself would have involved laboratory optimization and characterization experiments to ensure its chemical specificity and performance.
§ 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.