(62 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 hydrolysed 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, focusing on the acceptance criteria and the study that proves the device meets those criteria:
The provided document describes the Abbott Laboratories' Cholesterol assay, an in vitro diagnostic device, and its 510(k) summary for substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
This study establishes substantial equivalence to a predicate device rather than setting explicit acceptance criteria for diagnostic accuracy per se. The key performance characteristics are compared against a predicate device and a reference method.
| Performance Characteristic | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Abbott Cholesterol Assay) |
|---|---|---|
| Method Correlation | Acceptable correlation with the predicate device (Roche® Cobas Mira® Plus Automated Chemistry System Cholesterol assay). | Correlation coefficient = 0.9887, slope = 0.916, and Y-intercept = 0.206 mg/dL. This was deemed acceptable. |
| Traceability | Validation against the Abell-Kendall reference method. Implicitly, agreement with this gold standard is expected. | Validated against the Abell-Kendall reference method in a CDC-Certified Cholesterol Reference Method Network Laboratory (CRMLN). A Certificate of Traceability was included. |
| Precision | Acceptable within-run, between-run, and between-day precision using control material. Not explicitly quantified as an acceptance criterion in the text. | Total %CV for Level 1/Panel 111 control is 2.2%. Total %CV for Level 2/Panel 112 control is 2.7%. |
| Linearity Range | An acceptable linear range for cholesterol measurement. Not explicitly quantified as an acceptance criterion in the text. | Linear up to 530 mg/dL. |
| Limit of Quantitation | An acceptable limit of quantitation (sensitivity). Not explicitly quantified as an acceptance criterion in the text, but a specific value is reported. | 0.970 mg/dL. |
| Overall Equivalence | The Cholesterol assay must demonstrate substantial equivalence in performance characteristics to the Roche® Cobas Mira® Plus Automated Chemistry System Cholesterol assay. | Demonstrated by the results of the comparative studies. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size (number of patient samples) used for the comparative performance studies or precision studies. It mentions two levels of control material for precision studies.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable in the traditional sense for diagnostic image analysis. The "ground truth" for the method comparison was the Roche Cobas Mira Plus Automated Chemistry System Cholesterol assay and the Abell-Kendall reference method.
- Qualifications of Experts: The Abell-Kendall reference method validation was conducted in a CDC-Certified Cholesterol Reference Method Network Laboratory (CRMLN). This implies expert-level operation and certification for cholesterol measurement. No individual expert qualifications are provided for the Roche Cobas Mira Plus assay's results, as it's a commercially available device.
4. Adjudication Method for the Test Set
- Not applicable as this is not a study involving human readers or subjective interpretation of results requiring adjudication. The comparison is between quantitative chemical assays.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for devices that aid human readers in interpreting clinical images or other subjective data. This device is a quantitative in vitro diagnostic assay.
6. Standalone Performance Study
- Yes, a standalone performance was done in the sense that the Abbott Cholesterol assay's performance (correlation, precision, linearity, limit of quantitation) was evaluated. However, this "standalone" evaluation was primarily in comparison to a predicate device and a reference method to establish substantial equivalence, rather than a standalone clinical utility study without any reference point. The entire submission is focused on demonstrating the device's intrinsic performance characteristics.
7. Type of Ground Truth Used
- For Method Comparison: The ground truth for the primary comparative study was the results from the Roche Cobas Mira Plus Automated Chemistry System Cholesterol assay (predicate device) and the Abell-Kendall reference method (gold standard clinical chemistry reference method).
- For Precision, Linearity, Limit of Quantitation: These were determined through experimental protocols using established laboratory practices (e.g., measuring known concentration controls, serially diluted samples).
8. Sample Size for the Training Set
- Not applicable. This device is a biochemical assay, not an AI/machine learning algorithm requiring a "training set" in the computational sense. The "training" analogous to this would be the development and optimization of the reagent formulation and assay parameters based on laboratory experimentation and chemical principles.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the reasons stated above.
§ 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.