(25 days)
Sigma Diagnostics INFINITY™ Cholesterol Reagent is intended for the in vitro quantitative, diagnostic determination of cholesterol in human serum and plasma.
Measurement of serum cholesterol levels can serve as an indicator of liver function, biliary function, intestinal absorption, propensity toward coronary artery disease, thyroid function and adrenal disease. Cholesterol levels are important in the diagnosis and classification of hyperlipoproteinaemias. Stress, age, gender, hormonal balance and pregnancy affect normal cholesterol levels.
Sigma Diagnostics INFINITY™ Cholesterol Reagent is intended for the in vitro quantitative, diagnostic determination of cholesterol in human serum or plasma. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
This reagent is based on the formulation of Allain et al. and the modification of Roeschlau with further improvements to render the reagent stable in solution.
- Cholesterol esters are enzymatically hydrolyzed by cholesterol esterase (CE) to cholesterol and free fatty acids. Cholesterol Esters CE Cholesterol + Fatty Acids
- Free cholesterol, including that originally present, is then oxidized by cholesterol oxidase (CO) to cholest-4-en-3-one and hydrogen peroxide. Cholesterol + O2 CO Cholest-4-3-one + H2O2
- The hydrogen peroxide combines with hydroxybenzoic acid (HBA) and 4-aminoantipyrine (AAP) in the presence of peroxidase (POD) to form a chromophore (quinoneimine dye) which may be quantitated at 500-550 nm. For bichromatic analyzers the blank wavelength should be set to 600 or 650 am.
2H2O2 + HBA + 4AAP POD Quinoneimine Dye + 4H2O
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Acceptance Criteria and Study Details
The provided documentation describes the Sigma Diagnostics INFINITY™ Cholesterol Reagent, which is an in vitro diagnostic device for the quantitative determination of cholesterol. The substantial equivalence claim is made against the TRACE Scientific Cholesterol Reagent Kit (K962890) and the Sigma Diagnostics Cholesterol Reagent, Procedure No. 352 (K872295).
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device, the primary "acceptance criterion" demonstrated in the 510(k) summary is substantial equivalence to existing legally marketed devices, rather than a set of predefined performance thresholds for accuracy, precision, or other analytical metrics typical of new device validations.
| Acceptance Criterion (Implicitly for Substantial Equivalence) | Reported Device Performance | Comments |
|---|---|---|
| Correlation with Predicate Device (K872295) | Regression Equation: INFINITY Cholesterol = 1.00 (Cholesterol 352) - 0.3 | This regression equation indicates a very strong linear correlation with the predicate device, suggesting near-identical results across the tested range. A slope of 1.00 and an intercept of -0.3 indicate highly similar performance. The "acceptance" is implicitly that these correlation results demonstrate that the new device performs acceptably similarly to the predicate. |
| Same Product as K962890 | The Sigma Diagnostics INFINITY™ Cholesterol Reagent Kit (Procedure No. 401) is substantially equivalent to, and is the same product as the TRACE Scientific Cholesterol Reagent Kit cleared by FDA as K962890. | This statement establishes that the device is, in fact, the same product as a previously cleared device (K962890), which inherently means it meets the acceptance criteria of that prior clearance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 126 plasma samples
- Data Provenance: The document does not explicitly state the country of origin. It can be inferred that the samples were likely obtained within the region where Sigma Diagnostics operates (St. Louis, Missouri is listed as their address). The study is retrospective as it involves correlation with an existing, already marketed device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable in the context of this 510(k) submission.
- The "ground truth" here is the measurement obtained from the predicate device (Sigma Diagnostics Cholesterol Reagent, Procedure No. 352). This is a comparative study against another diagnostic assay, not against a gold standard established by human experts interpreting images or complex clinical data.
- Therefore, no human experts were used to establish the ground truth for these 126 samples. The "ground truth" is the quantitative result generated by the predicate assay.
4. Adjudication Method for the Test Set
This information is not applicable. As explained above, the "ground truth" is the quantitative result from a predicate device, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done.
- This type of study is relevant for imaging devices or AI-assisted diagnostic tools where human readers are involved. This submission concerns an in vitro diagnostic reagent, which provides a quantitative biochemical measurement, not a subjective interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, in a sense, a standalone study was done. The device itself (the reagent and its associated chemistry) produces a quantitative result independently. The correlation study directly measures the performance of this "standalone" system against another "standalone" system (the predicate device). There is no "human-in-the-loop" component in the direct measurement process of cholesterol levels by these reagents.
7. The Type of Ground Truth Used
- Comparative Reference: The ground truth for the 126 plasma samples was the cholesterol measurement obtained using the Sigma Diagnostics Cholesterol Reagent, Procedure No. 352 (K872295). This serves as a comparative reference method rather than a biological "gold standard" or pathology.
8. The Sample Size for the Training Set
- Not applicable. This device is a chemical reagent, not a machine learning or AI algorithm in the contemporary sense. Therefore, there is no "training set" in the context of AI models. The "training" for such a system involves chemical formulation and optimization, not data-driven model training.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply here. The development of the reagent involves chemical engineering and analytical validation against established scientific principles and methods.
§ 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.