(186 days)
The HDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of high-density lipoprotein cholesterol (HDL-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 HDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and heparinized- or EDTA-plasma on automated chemistry analyzers. The HDL-EX SEIKEN Assay is a homogeneous method for directly measuring HDL-C levels in serum and plasma without the need for any off-line pretreatment or centrifugation steps.
The provided text describes a 510(k) summary for the "HDL-EX SEIKEN Assay Kit," a device for quantitatively determining high-density lipoprotein cholesterol (HDL-C). The study presented is a comparative performance study against a predicate device.
Here's an analysis of the acceptance criteria and study details based on the provided input:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines acceptance criteria through the comparison to the predicate device, Ultra N-Geneous HDL Cholesterol Reagent. The key metrics evaluated are correlation, slope, and y-intercept for comparative performance, and Coefficient of Variation (CVs) for precision.
| Acceptance Criterion | Reported Device Performance (HDL-EX SEIKEN Assay) |
|---|---|
| Comparative Performance (vs. Predicate Device): | |
| Correlation Coefficient (r) | 0.991 (considered "high") |
| Slope | 1.041 |
| Y-intercept | 0.015 |
| Precision (Within-run and Between-day): | |
| Coefficient of Variation (CVs) | "showed very similar CVs as shown in the kit insert of the predicate device" |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: 150 donor samples.
- Data Provenance: Not explicitly stated, but the submission is from a Japanese company (Denka Seiken Co., Ltd.). It is likely these samples were collected in Japan or a similar region, but this is not confirmed. The study appears to be prospective in the sense that the samples were analyzed specifically for this comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This study evaluates an in vitro diagnostic (IVD) assay (a laboratory test), not an imaging device or a clinical outcome-based assessment. Therefore, the concept of "experts establishing ground truth" in the traditional sense (e.g., radiologists interpreting images) does not directly apply here.
- The "ground truth" for comparison is the performance of the legally marketed predicate device (Ultra N-Geneous HDL Cholesterol Reagent [Genzyme Corp.]) on the same samples. The predicate device itself has established performance characteristics, and its results are used as the reference against which the new device is measured.
- No information is provided about experts interpreting the results beyond the intrinsic performance of the predicate device.
4. Adjudication Method for the Test Set:
- Not applicable in the context of this type of IVD comparative performance study. The comparison is objective, based on quantitative measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC study was not done. This is an IVD device measuring a biomarker, not a device requiring human interpretation of medical images or diagnostic outputs.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, this study represents a standalone performance evaluation of the HDL-EX SEIKEN Assay Kit. As an automated chemistry analyzer test, it operates without human intervention in the interpretive phase. The study directly compares the results of the new assay to the predicate assay.
7. The Type of Ground Truth Used:
- The ground truth (or reference standard) used for the comparative performance study is the results obtained from the legally marketed predicate device, the "Ultra N-Geneous HDL Cholesterol Reagent [Genzyme Corp.]." This is a common practice for demonstrating substantial equivalence for IVD devices.
8. The Sample Size for the Training Set:
- The document does not mention a "training set" or any machine learning/AI components. This is a traditional IVD assay, not an AI/ML-based device. Therefore, the concept of a training set is not applicable.
9. How the Ground Truth for the Training Set Was Established:
- As there is no training set for this traditional IVD device, this question is not applicable.
§ 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.