(50 days)
Sigma Diagnostics EZ HDL™ Reagent (Procedure 354) is a device intended to measure HDL cholesterol in plasma and serum. Cholesterol measurements and HDL cholesterol measurements are used in the diagnosis and treatment of disorders of lipid and lipoprotein metabolism. Sigma Diagnostics EZ HDL™ Calibrator (354-5) is a device intended for medical purposes for use in a HDL cholesterol test system to establish points of reference that are used in the determination of values in the measurement of HDL cholesterol in plasma and serum.
Anti human B-lipoprotein antibody in Reagent 1 binds to lipoproteins (LDL, VLDL, and chylomicrons) other than HDL. The antigen-antibody complexes formed block enzyme reactions when Reagent 2 is added. Cholesterol esterase (CHE) and cholesterol oxidase (CO) in Reagent 2 react only with HDL-C. Hydrogen peroxide produced by the enzyme reactions with HDL-C yields a blue color complex upon oxidase condensation with FDAOS and 4-aminoantipyrine (4AA) in the presence of peroxidase (POD), By measuring the absorbance of the blue color complex produced, at approximately 600nm, the HDL-C concentration in the sample can be calculated with the absorbance of the EZ HDL™ Calibrator.
This document describes the Summary of Safety and Effectiveness for the EZ HDL™ Cholesterol, Procedure No. 354 device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Metric | Acceptance Value | Reported Device Performance (EZ HDL™ Cholesterol) |
|---|---|---|---|
| Equivalence to Reference Method | Correlation Coefficient (vs. Cholesterol Reference Method Laboratory Network standardized 50K molecular weight Dextran Sulphate precipitation method) | Not explicitly stated as a numerical 'acceptance value', but implied to be high for "substantial equivalency". | 0.980 |
| Equivalence to Reference Method | Regression Equation (vs. Cholesterol Reference Method Laboratory Network standardized 50K molecular weight Dextran Sulphate precipitation method) | Not explicitly stated as a numerical 'acceptance value', but implied to be close to y=x (i.e., slope near 1, intercept near 0) for "substantial equivalency". | y = 0.82x + 7.48 |
| Equivalence to Predicate Device | Correlation Coefficient (vs. Sigma Diagnostics 352-7 Phosphotungstic Acid procedure) | Not explicitly stated as a numerical 'acceptance value', but implied to be high for "substantial equivalency". | 0.990 |
| Equivalence to Predicate Device | Regression Equation (vs. Sigma Diagnostics 352-7 Phosphotungstic Acid procedure) | Not explicitly stated as a numerical 'acceptance value', but implied to be close to y=x (i.e., slope near 1, intercept near 0) for "substantial equivalency". | y = 0.97x + 5.07 |
| Precision | Within-run precision | Acceptable values for replication | "indicate acceptable values can be replicated" |
| Precision | Total precision | Acceptable values for replication | "indicate acceptable values can be replicated on a day to day basis" |
| Linearity | Upper limit of linear range | Not explicitly stated as a numerical 'acceptance value', but needs to be sufficient for clinical use. | 180 mg/dL |
| Interference | Triglyceride concentration interference | Not explicitly stated as a numerical 'acceptance value', but needs to be sufficient for clinical use. | Up to 2100 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 97 serum samples were used for the comparison study against the Cholesterol Reference Method Laboratory Network standardized 50K molecular weight Dextran Sulphate precipitation method.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is implied to be clinical samples used in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not applicable. The "ground truth" was established by recognized reference methods or predicate devices, not by expert interpretation of data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. The comparison was quantitative against established methods, not subjective interpretation requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic reagent, not an imaging or diagnostic device that relies on human reader interpretation. The study was a comparison of quantitative measurements.
- Effect Size: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Standalone Performance: Yes, the entire study focuses on the standalone performance of the EZ HDL™ Cholesterol Reagent. The effectiveness is demonstrated by its performance in measuring HDL-C concentrations compared to reference and predicate methods, without human interpretation as part of the measurement process itself beyond standard laboratory procedures.
7. The Type of Ground Truth Used:
- Ground Truth Type: The ground truth was established by recognized reference methods and predicate devices.
- Reference Method: Cholesterol Reference Method Laboratory Network standardized 50K molecular weight Dextran Sulphate precipitation method.
- Predicate Device: Sigma Diagnostics 352-7 Phosphotungstic Acid procedure.
8. The Sample Size for the Training Set:
- Training Set Sample Size: The document does not describe a separate "training set" as would be used for a machine learning algorithm. This device is a chemical reagent-based assay. Its development would involve internal validation and optimization, but the provided summary focuses on the final performance validation using test samples.
9. How the Ground Truth for the Training Set Was Established:
- Training Set Ground Truth Establishment: Not applicable, as a distinct training set in the context of machine learning is not described. The performance of the reagent is based on its chemical reactions and analytical characteristics, which would have been optimized during its development using established analytical chemistry principles and potentially internal comparisons to reference methods.
§ 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.