(63 days)
The LDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum and heparinized- or EDTA-plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus, atherosclerosis and various liver and renal diseases). The device is intended to be used on automated chemistry analyzers in clinical laboratories.
The LDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum and heparinized- or EDTA-plasma on automated chemistry analyzers. The LDL-EX SEIKEN Assay Kit is a homogeneous method for directly measuring LDL-C levels in serum and plasma without the need for any off-line pretreatment or centrifugation steps.
The provided text describes the 510(k) summary for the "LDL-EX SEIKEN Assay Kit." Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation with Predicate Device | r = 0.994 |
| - Slope | 0.982 |
| - Y-intercept | -1.83 |
| Precision (Within-run and Between-day CVs) | Very similar to the predicate device's kit insert. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: 100 donor samples
- Data Provenance: The document does not specify the country of origin for the donor samples or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the ground truth was established by comparison with a legally marketed predicate device, not through expert consensus on diagnostic images or pathology.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. The study involved direct comparison of quantitative results between the new device and a predicate device, not human review and adjudication of findings.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study was done for the device, where its measurements were directly compared against a predicate device. The device itself (the "LDL-EX SEIKEN Assay Kit") is an automated assay, meaning it operates without human intervention once the sample is loaded.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth was established by comparison to a legally marketed predicate device (N-Geneous LDL Cholesterol Reagent [Genzyme Corp.]). The assumption is that the predicate device provides accurate measurements of LDL-C, thereby serving as the "ground truth" for the new device's performance evaluation.
8. The sample size for the training set
This information is not applicable. This device is a chemical assay kit, not a machine learning or AI model, thus it does not have a "training set" in the conventional sense. Its performance is characterized through direct comparison and precision studies.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for this type of 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.