(49 days)
The Cholesterol assay is used for the quantitation 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.
Cholesterol is an in vitro diagnostic assay for the quantitative determination of cholesterol in human serum or plasma. The Cholesterol assay is a clinical chemistry assay in which cholesterol esters are enzymatically hydrolyzed by cholesterol esterase to cholesterol and free fatty acids. Free cholesterol, including that originally present, is then oxidized by cholesterol oxidase to cholest-4-en-3-one and hydrogen peroxide. The hydrogen peroxide combines with Hydroxybenzoic Acid and 4-aminoantipyrine to form a chromophore (quinoneimine dye) which can be measured.
Here's an analysis of the provided text, outlining the acceptance criteria and the study proving the device meets them:
Device: Cholesterol Assay (Abbott Laboratories)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Correlation Coefficient | 0.9929 (against Boehringer Mannheim® Cholesterol assay on Hitachi® 717 Analyzer) |
| Slope | 1.016 (against Boehringer Mannheim® Cholesterol assay on Hitachi® 717 Analyzer) |
| Y-intercept | 0.933 mg/dL (against Boehringer Mannheim® Cholesterol assay on Hitachi® 717 Analyzer) |
| Total %CV (Level 1/Panel 101 control) | 0.8% |
| Total %CV (Level 2/Panel 102 control) | 1.6% |
| Linearity Range | Up to 705.3 mg/dL |
| Limit of Quantitation (Sensitivity) | 4.4 mg/dL |
| "Similar" Performance Characteristics (to predicate device) | Achieved, as evidenced by correlation, slope, and Y-intercept. |
| "Similar" Clinical Results (to predicate device) | Stated as achieved. |
| "Similar" Assay Range (to predicate device) | Stated as achieved. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the test set in terms of the number of patient samples. It mentions "Comparative performance studies" were conducted and "Precision studies were conducted using two levels of control material."
- Sample Size for Comparative Performance (Method Comparison): Not explicitly stated in terms of number of patient samples.
- Sample Size for Precision Studies: Two levels of control material were used.
- Data Provenance: The document does not specify the country of origin. It indicates the studies were conducted using the AEROSET™ System and validated against the Abell-Kendall reference method in a CDC-Certified Cholesterol Reference Method Laboratory Network (CRMLN). This implies these were likely prospective studies specifically designed for device validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable in the context of this in vitro diagnostic device for cholesterol. The "ground truth" for cholesterol measurement is established by reference methods and validated analytical techniques, not by expert consensus on interpretation.
- The Cholesterol assay was "validated against the Abell-Kendall reference method in a CDC-Certified Cholesterol Reference Method Laboratory Network (CRMLN)." The Abell-Kendall method is a definitive chemical measurement, and the CRMLN provides certified reference materials and methods.
4. Adjudication Method for the Test Set
Not applicable. The determination of cholesterol levels is a quantitative analytical measurement, not subject to 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 or diagnostic devices that require human interpretation and aims to assess the impact of AI assistance on human reader performance. This device is an in vitro diagnostic assay for direct quantitative measurement.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the primary performance evaluation presented is a standalone performance of the Cholesterol assay device. The comparison is against a predicate device and a reference method, indicating the device itself, running independently, produced the reported results. There is no mention of human-in-the-loop performance given the nature of the assay.
7. The Type of Ground Truth Used
The ground truth was established using:
- Reference Method: The Abell-Kendall reference method, performed in a CDC-Certified Cholesterol Reference Method Laboratory Network (CRMLN). This is a highly robust and authoritative ground truth for cholesterol quantitation.
- Predicate Device: The Boehringer Mannheim® Cholesterol assay on the Hitachi® 717 Analyzer, which serves as a comparison benchmark for substantial equivalence.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" as this device is an in vitro diagnostic assay, not an AI/machine learning algorithm that typically requires a distinct training and test set. The described studies are validation or verification studies for the analytical performance of the assay.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" and its associated ground truth is not applicable to this type of in vitro diagnostic assay. Performance is assessed through direct comparison to established reference methods and predicate devices.
§ 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.