(166 days)
The S-Test Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum or heparin plasma using the S40 Clinical Analyzer. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test High Density Lipoprotein Reagent is intended for the quantitative determination of HDL 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 Triglycerides Reagent is intended for the quantitative determination of triglyceride concentration in serum or heparin plasma using the S40 Clinical Analyzer. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Cholesterol (CHO), S-Test HDL Cholesterol (HDL) and S-Test Triglycerides (TG) reagent cartridges, used with the S40 Clinical Analyzer, are intended for quantitative in vitro diagnostic determination of CHO, HDL, and TG concentrations in serum or heparin plasma based on a photometric test measuring the formation of reddish purple complexes in coupled enzymatic reactions.
The provided text describes the 510(k) summary for the S-Test Cholesterol (CHO), S-Test High Density Lipoprotein Cholesterol (HDL), and S-Test Triglycerides (TG) reagent cartridges for use with the S40 Clinical Analyzer. This summary outlines the performance data for each test.
Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| S-Test CHO | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | |
| Precision (Within-run CV) | Not explicitly stated as acceptance criteria, but demonstrated to be within acceptable ranges for clinical laboratory assays. | In testing three CHO levels for 22 days, the within-run CV ranged from 0.9% to 1.6%. In precision studies at three separate Physician Office Laboratory (POL) sites and in-house over five days, the within-run CV ranged from 0.3% to 2.0%. |
| Precision (Total CV) | Not explicitly stated as acceptance criteria, but demonstrated to be within acceptable ranges for clinical laboratory assays. | In testing three CHO levels for 22 days, the total CV ranged from 2.2% to 2.6%. In precision studies at three separate POL sites and in-house over five days, the total CV ranged from 0.7% to 2.0%. |
| Accuracy (Correlation Coefficient) | Not explicitly stated, but high correlation (close to 1) with comparative method is expected. | 0.983 (in-house study) and 0.9585 to 0.9969 (POL sites) using least-squares regression analysis against a comparative method. |
| Accuracy (Confidence Interval Slope) | Not explicitly stated, but expected to be close to 1. | 0.942 to 1.014 (in-house study) and 0.868 to 1.056 (POL sites). |
| Accuracy (Confidence Interval Intercept) | Not explicitly stated, but expected to be close to 0. | -3.8 to 10.8 (in-house study) and -15.7 to 16.2 (POL sites). |
| Accuracy (Standard Error Estimate) | Not explicitly stated, but low values are preferred. | 11.3 (in-house study) and 4.8 to 16.7 (POL sites). |
| Detection Limit | Not explicitly stated, but a low value is preferred for analytical sensitivity. | 7 mg/dL. |
| Serum vs. Plasma Difference | Difference less than ±5% tolerance limit. | Means for serum (149 mg/dL) and plasma (147 mg/dL) differed by less than ±5%. Serum range: 22 to 249 mg/dL. |
| S-Test HDL | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | |
| Precision (Within-run CV) | Not explicitly stated as acceptance criteria. | In testing three HDL levels for 23 days, the within-run CV ranged from 2.0% to 2.8%. In precision studies at three separate POL sites and in-house over five days, the within-run CV ranged from 1.2% to 2.8%. |
| Precision (Total CV) | Not explicitly stated as acceptance criteria. | In testing three HDL levels for 23 days, the total CV ranged from 6.0% to 6.5%. In precision studies at three separate POL sites and in-house over five days, the total CV ranged from 1.2% to 3.4%. |
| Accuracy (Correlation Coefficient) | Not explicitly stated, but high correlation (close to 1) with comparative method is expected. | 0.970 (in-house study) and 0.9696 to 0.9957 (POL sites) using least-squares regression analysis against a comparative method. |
| Accuracy (Confidence Interval Slope) | Not explicitly stated, but expected to be close to 1. | 0.923 to 1.022 (in-house study) and 0.879 to 1.020 (POL sites). |
| Accuracy (Confidence Interval Intercept) | Not explicitly stated, but expected to be close to 0. | -0.5 to 5.2 (in-house study) and -0.7 to 9.0 (POL sites). |
| Accuracy (Standard Error Estimate) | Not explicitly stated, but low values are preferred. | 4.8 (in-house study) and 1.7 to 4.7 (POL sites). |
| Detection Limit | Not explicitly stated, but a low value is preferred. | 6 mg/dL. |
| Serum vs. Plasma Difference | Not statistically significant difference between means (paired t-test, α = 0.05). | Paired t-test for means resulted in a t-Statistic of 0.40, which was not statistically significant at α = 0.05 (t-Critical value 2.03). Range: 14 to 124 mg/dL (serum). |
| S-Test TG | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | |
| Precision (Within-run CV) | Not explicitly stated as acceptance criteria. | In testing three TG levels for 22 days, the within-run CV ranged from 3.3% to 4.1%. In precision studies at three separate POL sites and in-house over five days, the within-run CV ranged from 0.5% to 3.9%. |
| Precision (Total CV) | Not explicitly stated as acceptance criteria. | In testing three TG levels for 22 days, the total CV ranged from 3.8% to 4.3%. In precision studies at three separate POL sites and in-house over five days, the total CV ranged from 0.6% to 3.9%. |
| Accuracy (Correlation Coefficient) | Not explicitly stated, but high correlation (close to 1) with comparative method is expected. | 0.997 (in-house study) and 0.9958 to 0.9990 (POL sites) using least-squares regression analysis against a comparative method. |
| Accuracy (Confidence Interval Slope) | Not explicitly stated, but expected to be close to 1. | 1.049 to 1.088 (in-house study) and 0.940 to 1.084 (POL sites). |
| Accuracy (Confidence Interval Intercept) | Not explicitly stated, but expected to be close to 0. | -21.2 to -13.7 (in-house study) and -19.0 to 2.9 (POL sites). |
| Accuracy (Standard Error Estimate) | Not explicitly stated, but low values are preferred. | 8.7 (in-house study) and 6.6 to 11.9 (POL sites). |
| Detection Limit | Not explicitly stated, but a low value is preferred. | 12 mg/dL. |
| Serum vs. Plasma Difference | Not statistically significant difference between means (paired t-test, α = 0.05). | Paired t-test for means resulted in a t-Statistic of 2.04, which was not statistically significant at α = 0.05 (t-Critical value 2.05). Range: 36 to 572 mg/dL (serum). |
Study Proving Device Meets Acceptance Criteria:
The studies described are primarily analytical performance studies conducted by Alfa Wassermann Diagnostics Technologies, LLC, both in-house and at Physician Office Laboratory (POL) sites. These studies evaluated precision, accuracy, detection limits, and matrix comparisons (serum vs. plasma).
Additional Information on the Study:
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Sample sizes used for the test set and the data provenance:
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S-Test CHO:
- Accuracy (correlation study): 98 samples (range: 31 to 335 mg/dL).
- Accuracy (POL sites): Sample sizes not explicitly stated, but refers to "patient correlation studies."
- Serum vs. Plasma: 29 paired samples.
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S-Test HDL:
- Accuracy (correlation study): 94 samples (range: 15 to 116 mg/dL).
- Accuracy (POL sites): Sample sizes not explicitly stated, but refers to "patient correlation studies."
- Serum vs. Plasma: 36 paired samples.
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S-Test TG:
- Accuracy (correlation study): 87 samples (range: 24 to 584 mg/dL).
- Accuracy (POL sites): Sample sizes not explicitly stated, but refers to "patient correlation studies."
- Serum vs. Plasma: 30 paired samples.
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Data Provenance: The studies were conducted by the manufacturer, Alfa Wassermann Diagnostic Technologies, LLC, both in-house ('in-house over five days') and at three separate Physician Office Laboratory (POL) sites. The text does not specify the country of origin of the data, but the 510(k) owner is based in West Caldwell, NJ, USA. The data appears to be prospective in nature, as indicated by controlled experiments like "testing three CHO levels for 22 days."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is an analytical performance study for an in vitro diagnostic (IVD) device, not an interpretative imaging or diagnostic test requiring human expert adjudication for ground truth.
- The "ground truth" or reference method for accuracy studies was a "comparative method (x)." The specific identity or nature of this comparative method is not detailed, but for IVDs, this typically refers to a well-established, often FDA-cleared, reference assay run on another analyzer or a gold standard method. No human experts are described as establishing ground truth in this context.
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Adjudication method for the test set:
- Not applicable. This is an analytical performance study comparing the device's quantitative measurements against a comparative method. There is no human adjudication process involved as would be seen in image interpretation or clinical diagnosis studies.
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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:
- Not applicable. This is an analytical performance study of an in vitro diagnostic (IVD) assay, not an AI-assisted diagnostic imaging or interpretative tool. There are no human readers or AI involved in the interpretation of results in this context.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance data presented are for the standalone analytical performance of the S-Test reagent cartridges on the S40 Clinical Analyzer. This represents the "algorithm only" or device-only performance for quantitative measurements of cholesterol, HDL, and triglycerides. There is no mention of a human-in-the-loop component in the direct measurement process.
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The type of ground truth used:
- The "ground truth" for the accuracy studies was established by a "comparative method (x)." This means the new device's measurements were compared against another existing, presumably validated, method for measuring cholesterol, HDL, and triglycerides. This is a common practice for demonstrating analytical accuracy for IVD devices, comparing to a "reference standard" or "predicate device" method.
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The sample size for the training set:
- Not applicable. This is an analytical performance study of a reagent system, not a machine learning or AI model that requires a training set. The device's performance is characterized through experiments.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned in the context of this analytical performance study.
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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.