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510(k) Data Aggregation
(91 days)
Reagent: For the quantitative determination of high-density cholesterol lipoprotein cholesterol in human serum or plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus, atherosclerosis and various liver and renal diseases). For In Vitro Diagnostic Use. Calibrator: For calibration of the Ultra HDL Cholesterol assay. For In Vitro Diagnostic Use.
The new Ultra N-geneous® HDL Cholesterol Kit is a two-reagent homogeneous method for the direct quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum and plasma. The new Ultra N-geneous® HDL Cholesterol assay does not contain polyanion or divalent metal. "precipitation reagent". This new method is based on accelerating the reaction of cholesterol oxidase and dissolving HDL selectively using a specific detergent.
This document describes the validation of the Genzyme Ultra N-geneous® HDL Cholesterol Reagent and Calibrator. The device is a two-reagent homogeneous method for the direct quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma. The validation aims to demonstrate its substantial equivalence to the current Liquid N-geneous® HDL Cholesterol Reagent method and the Centers for Disease Control (CDC) designated comparison method.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparative performance results and the NCEP goals for precision. The reported device performance is presented in comparison to the predicate devices.
Comparative Performance (Ultra N-geneous® HDL vs. Predicates)
| Performance Metric | Acceptance Criteria (Implied) | Reported Performance (vs. Liquid N-geneous® HDL) | Reported Performance (vs. Designated Comparison Method) |
|---|---|---|---|
| Slope | Close to 1.0 | 0.98 | 0.99 |
| Intercept (mg/dL) | Close to 0.0 | 3.42 | 2.81 |
| Correlation Coefficient (r) | High (e.g., >0.95) | 0.996 | 0.996 |
| Mean Difference (mg/dL) | Low (e.g., within clinical limits) | 2.3 | 2.0 |
| Mean Percent Difference | Low (e.g., within clinical limits) | 4.5 | 3.9 |
| Range (mg/dL) | - | 33.6 - 133.0 | 32.0 - 133.0 |
Precision Performance (Ultra N-geneous® HDL)
| Metric with NCEP Target | Low (<40 mg/dL) | Mid (40-59 mg/dL) | High (≥60 mg/dL) |
|---|---|---|---|
| Within-run n | 20 | 20 | 20 |
| Mean (mg/dL) | 32.9 | 50.6 | 101.4 |
| SD (mg/dL) | 0.3 | 0.2 | 0.7 |
| %CV | 0.8 | 0.5 | 0.7 |
| Between-run n | 40 | 40 | 40 |
| Mean (mg/dL) | 32.8 | 50.0 | 100.1 |
| SD (mg/dL) | 0.4 | 0.7 | 1.1 |
| %CV | 1.3 | 1.5 | 1.1 |
Physician Office Laboratory (POL) Performance (N-geneous™ HDL - Lyophilized format)
| POL Site | Correlation (vs. Genzyme ref lab) | Correlation (vs. POL's current HDL method) | NCEP CVs Achieved? | NCEP SD Achieved? |
|---|---|---|---|---|
| Site #1 | Not fully reported (Slope 1.11) | 0.97 | Yes (for CVs ≤5% at ≥42 mg/dL) | Yes (for SD ≤1.7 mg/dL at <42 mg/dL) |
| Site #2 | 0.99 | 0.99 | Yes (for CVs ≤5% at ≥42 mg/dL) | Yes (for SD ≤1.7 mg/dL at <42 mg/dL) |
| Site #3 | 0.99 (Slope 0.93) | 0.98 | Yes (for CVs ≤5% at ≥42 mg/dL) | Yes (for SD ≤1.7 mg/dL at <42 mg/dL) |
The study demonstrates that the Ultra N-geneous® HDL Cholesterol Reagent performs comparably to the predicate devices, with high correlation coefficients, low mean differences, and precision that meets NCEP goals.
2. Sample Size and Data Provenance
- Test Set for Comparative Studies:
- vs. current Liquid N-geneous® HDL: 101 serum samples.
- vs. Designated Comparison Method: 52 serum samples.
- Test Set for POL studies: 40 serum samples for each of the three POL sites.
- Provenance: The samples were "human serum and plasma." The studies were conducted at Genzyme Corporation (Cambridge, MA) and Pacific BioMetrics (Seattle, WA) for the primary comparative studies. The POL studies were conducted at three different physician office laboratories. The data appears to be prospective in the sense that specific experiments were conducted to generate this data for the submission.
3. Number of Experts and Qualifications (for Ground Truth)
- No "experts" in the traditional sense (e.g., radiologists interpreting images) were used for establishing ground truth.
- The ground truth for comparative studies was established by recognized reference methods:
- The "current Liquid N-geneous® HDL Cholesterol Reagent method."
- The "Center for Disease Control (CDC) designated comparison method (DCM)."
- The HDL reference method (ultracentrifugation, chemical precipitation, and Abell-Kendall) for samples with triglyceride levels >400 mg/dL.
- The qualifications of the personnel performing these reference methods are not explicitly stated but are presumed to be standard for clinical laboratory professionals following established protocols.
4. Adjudication Method
- Not applicable. This study involves quantitative measurements against reference methods, not subjective interpretation requiring adjudication among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This is a comparison of an in-vitro diagnostic device's analytical performance against predicate methods, not a study involving human readers or interpretation of results for diagnostic decisions where AI assistance might be beneficial.
6. Standalone Performance
- Yes, a standalone performance study was done. The comparative performance studies (vs. Liquid N-geneous® HDL and vs. DCM), as well as the precision studies, assess the performance of the Ultra N-geneous® HDL Cholesterol Reagent as a standalone algorithm (or assay). The results reported (slope, intercept, correlation, mean difference, %CV, SD) are all measures of the device's inherent analytical performance.
7. Type of Ground Truth Used
- The ground truth used was analytical reference methods:
- The existing "Liquid N-geneous® HDL Cholesterol Reagent method."
- The "Center for Disease Control (CDC) designated comparison method (DCM)."
- For specific cases (triglycerides >400 mg/dL), the "HDL reference method (ultracentrifugation, chemical precipitation, and Abell-Kendall)" was used.
- These are established laboratory methods considered to provide accurate measurements of HDL cholesterol.
8. Sample Size for the Training Set
- Not applicable. This document describes the validation of an in-vitro diagnostic reagent, not an AI/machine learning model that requires a "training set." The reagent's performance is based on chemical reactions and optical detection, not learned patterns from data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no "training set" in the context of this device.
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