(37 days)
The Ultra HDL assay is used for the quantitation of high-density lipoprotein cholesterol levels in human serum or plasma. Low HDL measurements are used in the diagnosis and treatment of coronary artery disease.
The Ultra HDL assay is a homogeneous method for directly measuring HDL cholesterol concentrations in serum or plasma without the need for any off-line pretreatment or centrifugation steps. The method uses a two-reagent format and depends on the properties of a unique detergent. This method is based on accelerating the reaction of cholesterol oxidase (CO) with non-HDL unesterified cholesterol and dissolving HDL cholesterol selectively using a specific detergent. In the first reagent, non-HDL unesterified cholesterol is subject to an enzyme reaction and the peroxide generated is consumed by a peroxidase reaction with DSBmT yielding a colorless product. The second reagent consists of a detergent (capable of solubilizing HDL cholesterol), cholesterol esterase (CE), and chromagenic coupler to develop color for the quantitative determination of HDL cholesterol.
- Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Predicate Device K021316) | Ultra HDL Performance (AEROSET System) | Ultra HDL Performance (ARCHITECT c8000 System) |
|---|---|---|---|
| Correlation Coefficient (vs. Predicate) | Acceptable correlation | 0.999 | 0.999 |
| Slope (vs. Predicate) | Acceptable correlation | 0.97 | 0.97 |
| Y-intercept (vs. Predicate) | Acceptable correlation | 0.46 mg/dL | 0.91 mg/dL |
| Inter-system Correlation (AEROSET vs. ARCHITECT) | Acceptable correlation | - | Correlation Coefficient: 0.999, Slope: 1.00, Y-intercept: 0.61 mg/dL |
| Total %CV (Level 1) | Not explicitly stated for predicate, but performance demonstrated as "substantially equivalent" | 5.5% | 3.3% |
| Total %CV (Level 2) | Not explicitly stated for predicate, but performance demonstrated as "substantially equivalent" | 1.4% | 1.4% |
| Linearity Range | Not explicitly stated for predicate, but performance demonstrated as "substantially equivalent" | 5 to 180 mg/dL | 5 to 180 mg/dL |
| Limit of Quantitation (Sensitivity) | Not explicitly stated for predicate, but performance demonstrated as "substantially equivalent" | 5 mg/dL | 5 mg/dL |
Note: The acceptance criteria are inferred from the claim of "substantially equivalent" performance to the predicate device (Genzyme N-geneous Ultra HDL Cholesterol assay). Exact numerical acceptance criteria for the predicate are not provided in the document, but the study demonstrates that the Ultra HDL assay achieved comparable results.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the specific number of individual patient or control samples used in the "Comparative performance studies" or "Precision studies." It refers to "Level 1" and "Level 2" for precision, implying control materials or different concentration ranges.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. This is an in vitro diagnostic device for quantitative measurement, not an imaging device requiring expert interpretation for ground truth. The 'ground truth' is established by the predicate device's measurements.
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Adjudication Method for the Test Set:
- Not applicable. This is not a study involving expert adjudication of diagnostic findings.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically for imaging devices where human readers interpret images, sometimes with and without AI assistance. This device is an in vitro diagnostic assay.
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Standalone Performance (Algorithm Only without Human-in-the-Loop):
- Yes, this study demonstrates the standalone performance of the Ultra HDL assay. It directly measures HDL cholesterol concentrations in serum or plasma. It is designed to be used without human-in-the-loop analysis beyond operating the instrument and interpreting the numerical output.
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Type of Ground Truth Used:
- The "ground truth" for evaluating the Ultra HDL assay was the results obtained from the Genzyme N-geneous Ultra HDL Cholesterol assay on the Hitachi 717 Analyzer, which is the predicate device. This is a form of comparative ground truth against an established and legally marketed method.
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Sample Size for the Training Set:
- The document does not specify a separate "training set" or its sample size. For an in vitro diagnostic assay, method development and optimization would occur prior to these performance studies, but the data presented focuses on the validation of the final assay.
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as a distinct training set and its ground truth establishment are not described in the context of this 510(k) summary for an in vitro diagnostic assay. The performance evaluation is against an established predicate device.
§ 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.