(115 days)
The LDL assay is used for the quantitation of low-density lipoprotein cholesterol levels in human serum or plasma. LDL measurements are used in the diagnosis and treatment of the pathogensis of arteriosclerosis and coronary artery disease.
LDL is an in vitro diagnostic assay for the quantitative determination of low-density lipoprotein cholesterol (LDL) in human serum or plasma. The detergent solubilizes only the non-LDL lipoprotein particles. The cholesterol released is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. Another detergent solubilizes the remaining LDL particles and a chromogenic coupler allows for color formation. The enzyme reaction with LDL cholesterol in the presence of the coupler produces color which is proportional to the amount of LDL cholesterol present in the sample.
Here's an analysis of the provided text regarding the acceptance criteria and study for the LDL assay:
1. Table of Acceptance Criteria and Reported Device Performance
The submission doesn't explicitly define formal "acceptance criteria" with specified thresholds for each performance characteristic. Instead, it presents performance characteristics and asserts that they demonstrate "substantial equivalence" to the predicate device. For the purpose of this table, I will infer the "acceptance criteria" as the performance demonstrated during the study being considered acceptable for substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Method Comparison | Acceptable correlation with predicate device (Roche Cobas Mira Plus Automated Chemistry System) | Correlation coefficient = 0.9546, Slope = 0.984, Y-intercept = 7.466 mg/dL |
| Precision (Total %CV) | Acceptable precision using control material | Level 1/Panel 141 control: 3.3% |
| Level 2/Panel 142 control: 4.0% | ||
| Linearity | Linear up to a high concentration | Linear up to 600 mg/dL |
| Limit of Quantitation | Low sensitivity value | 1 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size (number of patient samples) used for the method comparison or precision studies. It mentions "two levels of control material" for precision.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies were described as "Comparative performance studies were conducted using the ALCYON™ Analyzer."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of in vitro diagnostic device (IVD) submission. For chemical assays like LDL, the "ground truth" is typically established by reference methods, well-characterized control materials, or clinical outcomes, rather than expert interpretation of images or other subjective data. No experts for ground truth establishment are mentioned.
4. Adjudication Method for the Test Set
This section is not applicable. Since the device measures a chemical analyte, there is no subjective interpretation requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This section is not applicable. MRMC studies are relevant for devices that involve human interpretation (e.g., imaging diagnostics). This device is an automated in vitro diagnostic assay.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance presented is standalone. This device is an automated in vitro diagnostic assay. The performance characteristics described (correlation coefficient, precision, linearity, sensitivity) are inherent to the assay and the analyzer, without human intervention in the measurement process itself. Human involvement would primarily be in sample preparation, running the test, and interpreting the numerical results.
7. The Type of Ground Truth Used
The ground truth for this device's performance is established by comparison to a legally marketed predicate device (Roche Cobas Mira Plus Automated Chemistry System LDL assay) for method comparison, and by using control materials with known values for precision and linearity assessment. The concept of "expert consensus," "pathology," or "outcomes data" as ground truth is not relevant for this type of chemical assay.
8. The Sample Size for the Training Set
This section is not applicable. In vitro diagnostic assays like the LDL assay are typically developed and validated against established chemical principles and reference methods. They do not generally involve "training sets" in the same way machine learning algorithms do, where a model "learns" from a dataset. The formulation and calibration of the assay are based on chemical reactions, and performance is verified through analytical studies.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons mentioned in point 8.
§ 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.