(321 days)
The Wako Autokit Lp(a) test is an in vitro diagnostic assay for the quantitative determination of lipoprotein (a) in serum or plasma to aid, in conjunction with other lipoprotein tests, with the risk assessment of coronary artery disease (CAD).
The Wako Lp(a) assay is an in vitro turbidimetric immunoassay for the quantitative determination of lipoprotein(a) in serum or plasma to aid in the risk assessment of coronary heart disease (CAD).
The Wako Lp(a) test kit is based on the TIA methodology. When a sample is mixed with the Buffer and the Antibody, Lp(a) in the sample combines specifically with anti-human lipoprotein (a) antibodies in the reagent to vield an insoluble aggregate that causes turbidity. The degree of turbidity cab be measured optically and is proportional to the amount of Lp(a) in the sample.
The Wako Autokit Lp(a) test is an in vitro diagnostic assay for the quantitative determination of lipoprotein (a) in serum or plasma to aid, in conjunction with other lipoprotein tests, with the risk assessment of coronary artery disease (CAD).
Here's an analysis of its acceptance criteria and the study that proves the device meets them:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Aid in risk assessment of coronary artery disease (CAD) | Demonstrated substantial equivalency to the Apo-tek Lp(a) assay and Sigma's LDL in assessing cardiac risk. |
| Precision | Precision studies indicate acceptable values can be obtained on a day-to-day basis. |
| Minimum detectable level | Estimated to be 0.3 mg/dL. |
| Linearity | Determined to be linear to 100 mg/dL. |
2. Sample Size and Data Provenance
The document does not explicitly state the sample size used for the test set during the substantial equivalence study.
The data provenance is not specified, but typically, these studies for diagnostic devices involve clinical samples. It is not stated whether the data was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the number of experts used to establish ground truth for a test set, nor their qualifications. Given that the device is compared to other assays (Apo-tek Lp(a) and Sigma's LDL), the ground truth for CAD risk assessment would likely rely on the established clinical utility and accuracy of these predicate devices and broader clinical diagnostic standards for CAD.
4. Adjudication Method
The document does not specify an adjudication method. The study primarily focuses on demonstrating substantial equivalence to predicate devices, rather than a direct expert-adjudicated clinical outcome study for diagnostic accuracy.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This type of study is more common for imaging-based diagnostics where human interpretation is a primary component. The Wako Autokit Lp(a) is an in vitro turbidimetric immunoassay, which is an automated or semi-automated laboratory test.
6. Standalone (Algorithm Only) Performance Study
The information provided describes the performance of the Wako Autokit Lp(a) assay itself, which is a standalone in vitro diagnostic device (an "algorithm" in the context of a lab test). The reported precision, minimum detectable level, and linearity are all measures of its standalone performance. The "substantial equivalence" claim is a comparison of this standalone performance to other predicate devices.
7. Type of Ground Truth Used
The primary "ground truth" used for demonstrating effectiveness appears to be:
- Established performance of predicate devices: The Wako Autokit Lp(a) assay's ability to determine cardiac risk is proven by its substantial equivalency to the Apo-tek Lp(a) assay and Sigma's LDL, which are presumably already established as effective in assessing CAD risk.
- Analytical performance characteristics: Precision, minimum detectable level, and linearity are inherent analytical characteristics that define the assay's performance.
There is no mention of pathology, direct outcomes data, or expert consensus specific to a test set in the context of a new diagnostic accuracy study for clinical utility.
8. Sample Size for the Training Set
The document does not specify a training set or its sample size. For an in vitro diagnostic assay like this, "training" might refer to the internal development and calibration of the assay, which would involve numerous samples, but these are not explicitly detailed as a "training set" in the context of a validation study for regulatory submission.
9. How Ground Truth for the Training Set Was Established
As no specific training set is outlined, the method for establishing its ground truth is not described. The assay's development would involve using reference materials and samples with known Lp(a) concentrations for calibration and optimization, but this process is not detailed in the summary.
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).