(427 days)
The s LDL-EX"SEIKEN" test is for the quantitative determination of small, dense (sd) LDL cholesterol (-C) in human serum or plasma. The s LDL-EX"SEIKEN" test is used in conjunction with other lipid measurements and clinical evaluations to aid in the risk management of lipoprotein disorders associated with cardiovascular disease.
The assay consists of two steps and is based on the technique to use well-characterized surfactants and enzymes that selectively react with certain groups of lipoproteins.
In the first step, non-sd LDL lipoproteins, that is, chylomicrons, VLDL, IDL, L-LDL and HDL are decomposed by a surfactant and sphingomyelinase in Reagent-1 that is reactive to those non-sd LDL lipoproteins. The cholesterol released from such non-sd LDL lipoproteins is then degraded to water and oxygen by the action of enzymes. Cholesterol ester is hydrolyzed by the cholesterol esterase (CHE) and then oxidized by the cholesterol oxidase (CO). Produced hydrogen peroxides are finally decomposed to water and oxygen by the catalase.
In the second step, another surfactant in Reagent-2 releases cholesterol only from sd LDL particles and cholesterol released from sd LDL is then subject to the enzymatic reactions. As catalase in the reaction mixture is inhibited by sodium azide in Reagent-2, hydrogen peroxides, produced from the reaction with the cholesterol esterase and cholesterol oxidase, develop a purple-red color with the coupler in the presence of peroxidase (POD).
The provided text describes the acceptance criteria and a study demonstrating that the device meets these criteria. The device is the s LDL-EX "SEIKEN" test, which is for the quantitative determination of small, dense (sd) LDL cholesterol (-C) in human serum or plasma.
Here's an analysis of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document details performance characteristics rather than explicit "acceptance criteria" for a specific disease detection task, as this is a quantitative diagnostic test. The acceptance is based on the device's analytical performance and its ability to distinguish risk groups for CHD.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance | Study Type |
|---|---|---|---|
| Limit of Blank (LoB) | Not explicitly stated, but lower is better. | 0.20 mg/dL | Analytical Performance |
| Limit of Detection (LoD) | Not explicitly stated, but lower is better. | 0.38 mg/dL | Analytical Performance |
| Limit of Quantitation (LoQ) | %CVs less than 10% for the lowest concentration. | 1.14 mg/dL | Analytical Performance |
| Precision (Within-laboratory %CV) | %CV for each control/sample, at each site. | Range: 1.3% to 4.3% across different sites and samples. | Analytical Performance |
| Linearity (Nonlinearity) | Absolute value of nonlinearity less than allowable nonlinearity. | Absolute value of nonlinearity was less than allowable nonlinearity at all tested levels. Linear throughout 4.0 - 100 mg/dL. | Analytical Performance |
| Spike and Recovery (% difference) | Not explicitly stated, but low % difference is desired. | Range: -0.5% to +1.3%. | Analytical Performance |
| Interferences (Hemoglobin) | Less than 10% difference or 3 mg/dL difference (for low level). | No significant interference up to 1,000 mg/dL. | Analytical Performance |
| Interferences (Bilirubin) | Less than 10% difference or 3 mg/dL difference (for low level). | No significant interference up to 60 mg/dL (conjugated and unconjugated). | Analytical Performance |
| Interferences (Chyle) | Less than 10% difference or 3 mg/dL difference (for low level). | No significant interference up to 1,420 FTU. | Analytical Performance |
| Interferences (Sodium L-ascorbate) | Less than 10% difference or 3 mg/dL difference (for low level). | No significant interference up to 100 mg/dL. | Analytical Performance |
| Interferences (Intralipid) | Less than 10% difference or 3 mg/dL difference (for low level). | No significant interference up to 10%. (up to 1% wt/vol as soybean oil). | Analytical Performance |
| Interferences (Uric acid) | Less than 10% difference or 3 mg/dL difference (for low level). | No significant interference up to 15 mg/dL. | Analytical Performance |
| Interferences (Triglyceride) | Less than 10% difference or 3 mg/dL difference (for low level). | No significant interference up to 1,500 mg/dL. | Analytical Performance |
| Interferences (Drugs) | No interference at three-times therapeutic levels. | No interference found for listed drugs. | Analytical Performance |
| Matrix Equivalence (Correlation Coefficient) | Close to 1.00. | Serum (SST): 1.00; Plasma (K2 EDTA): 1.00; Plasma (Lithium Heparin): 1.00. | Analytical Performance |
| Matrix Equivalence (Slope) | Close to 1.00. | Serum (SST): 1.00; Plasma (K2 EDTA): 0.96; Plasma (Lithium Heparin): 0.99. | Analytical Performance |
| Matrix Equivalence (Intercept) | Close to 0. | Serum (SST): +0.1; Plasma (K2 EDTA): -0.1; Plasma (Lithium Heparin): -0.4. | Analytical Performance |
| Clinical Association with CHD | Demonstrates predictive value for incident CHD, and validates clinical cutoff. | sd LDL-C predicted future CHD events. Cutoff of 50.0 mg/dL was validated (HR 1.26 in fully adjusted model, p=0.0006 for sd LDL-C >= 50 mg/dL vs |
§ 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.