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510(k) Data Aggregation
(89 days)
S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022
The S-Test Low Density Lipoprotein Cholesterol Reagent is intended for the quantitative determination of LDL concentration in serum or heparin plasma using the S40 Clinical Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Low Density Lipoprotein (LDL) Cholesterol reagent cartridges, used with the S40 Clinical Analyzer, are intended for quantitative in vitro diagnostic determination of LDL cholesterol concentrations in serum or heparin plasma based on a photometric test measuring the formation of a reddish purple complex in a coupled enzymatic reaction.
1. Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance (S-Test LDL reagent with S40 Clinical Analyzer) |
|---|---|---|
| Precision | Not explicitly stated, but generally indicative of good clinical practice for quantitative assays. | Within-run CV: 1.2 to 2.2% (at three LDL levels over 22 days); 0.8 to 2.8% (at three POL sites over 5 days) |
| Total CV: 2.2 to 2.5% (at three LDL levels over 22 days); 1.2 to 2.8% (at three POL sites over 5 days) | ||
| Accuracy (Correlation to Comparative Method) | Not explicitly stated, but generally high correlation (e.g., R-value > 0.95) with acceptable bias and confidence intervals for slopes and intercepts are expected. | Correlation Coefficient: 0.996 (for 110 serum samples, 11-388 mg/dL) |
| Standard Error Estimate: 6.6 | ||
| Confidence Interval Slope: 0.948 to 0.982 | ||
| Confidence Interval Intercept: -1.7 to 3.4 | ||
| POL Site Correlations: 0.995 to 0.997 (correlation coefficients); 6.0 to 8.0 (standard error estimates); 0.895 to 0.967 (confidence interval slopes); -4.6 to 13.6 (confidence interval intercepts) | ||
| Sensitivity (Detection Limit) | Not explicitly stated, but a low detection limit is desirable for clinical utility, especially for lower values. | 1 mg/dL |
| Matrix Comparison (Serum vs. Plasma) | Not explicitly stated, but no statistically significant difference between serum and heparin plasma measurements is expected to demonstrate interchangeable use. | t-Statistic: 1.71 (for 34 paired samples, 13-350 mg/dL) |
| t-Critical Value: 2.03 at α = 0.05 | ||
| Conclusion: Not statistically significant difference between serum and plasma, confirming use of plasma. |
2. Sample Size and Data Provenance for the Test Set:
- Precision Studies:
- Main Study: Not explicitly stated, but "three LDL levels for 22 days" implies repeated measurements over time. The number of individual samples for within-run and total CV calculation would be based on these repeated measurements at each level.
- POL Site Studies: "three separate Physician Office Laboratory (POL) sites over 5 days" at "three separate POL sites." Similar to the main study, number of individual samples would be based on repeated measurements at each POL site.
- Accuracy (Correlation Study): 110 serum samples with LDL values ranging from 11 to 388 mg/dL.
- Matrix Comparison (Serum vs. Plasma): 34 paired samples drawn from the same patients.
- Data Provenance: The document does not explicitly state the country of origin for the data. Given the submission is to the FDA, it is likely the studies were conducted in the US or in a manner compliant with US regulatory standards. The studies appear to be prospective in nature, as they involve performing tests on samples to evaluate device performance.
3. Number of Experts and Qualifications for Ground Truth:
The document describes performance studies comparing the S-Test LDL reagent to a "comparative method" or a "predicate device" (Alfa Wassermann ACE plus ISE/Clinical Chemistry System with ACE Low Density Lipoprotein Cholesterol Reagent K991733).
- Number of Experts: Not applicable. The ground truth for this type of IVD device is typically established by another established, validated reference method or device, rather than by human expert consensus or interpretation of images.
- Qualifications of Experts: Not applicable. The "ground truth" is analytical results from an established comparative method or predicate device.
4. Adjudication Method for the Test Set:
Not applicable. The reported studies are analytical performance studies for an in vitro diagnostic (IVD) device, not studies involving human interpretation or adjudication. The "adjudication" is essentially the direct comparison of quantitative results between the candidate device and a comparative method using statistical analysis (e.g., least-squares regression, t-test).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices where human readers interpret outputs (e.g., medical images). The S-Test LDL Cholesterol Reagent is an automated in vitro diagnostic assay that provides a quantitative numerical result, not an image or output requiring human interpretation in the context of a "reader."
6. Standalone (Algorithm Only) Performance:
Yes, the studies described are standalone performance studies of the S-Test LDL Reagent used with the S40 Clinical Analyzer. The purpose is to demonstrate the analytical performance of the device itself (reagent and analyzer system) without human diagnostic interpretation being a variable in the performance assessment.
7. Type of Ground Truth Used:
The ground truth used was analytical measurements obtained from a comparative method or predicate device. This is a common approach for establishing the accuracy of new in vitro diagnostic assays by correlating their results with those of an already accepted and validated method.
8. Sample Size for the Training Set:
The document does not provide information on a "training set" in the context of machine learning or AI models. This device is a traditional in vitro diagnostic reagent and analyzer system, not an AI-powered device that requires training data. The studies described are for analytical validation.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a training set or AI model development in the provided text.
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