(53 days)
ACE® LDL-C Reagent is intended for use in the quantitative determination of low density lipoprotein cholesterol in human serum.
ACE® LDL-C Reagent is intended for the quantitative determination of LDL cholesterol in serum using the ACE® clinical chemistry system.
LDL-C Calibrator is intended for the calibration of the ACE® LDL-C Assay.
LDL-C Controls are intended to monitor the performance of the ACE® LDL-C Assay.
The measurement of LDL cholesterol is a factor in the pathogenesis of atherosclerosis and coronary artery disease.
The ACE® LDL-C Reagent contains two reagents. An aliquot of serum is added to the first reagent, which contains a unique detergent that selectively solubilizes the non LDL lipoproteins. Enzymes also present in the first reagent consume the cholesterol in a non color forming reaction. The second reagent contains another detergent that releases the remaining LDL lipoproteins. The enzyme reaction with LDL cholesterol, in the presence of a chromogenic coupler, produces color that is directly proportional to the amount of LDL cholesterol in the sample.
The ACE® LDL-C Reagent is intended for the quantitative determination of low density lipoprotein cholesterol in human serum.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Assay Range | 6.6 mg/dL to 992 mg/dL | 3 mg/dL to 800 mg/dL |
| Precision - Within Run | ≤ 0.73 %CV | ≤ 2.6 %CV |
| Precision - Between Run | ≤ 2.27 %CV | ≤ 3.2 %CV |
| Correlation vs. Reference method (Ultracentrifugation) - Slope | 0.95 | 1.111 |
| Correlation vs. Reference method (Ultracentrifugation) - Intercept | +3.02 | -15.5 |
| Correlation vs. Reference method (Ultracentrifugation) - r | 0.96 | 0.9747 |
| Correlation vs. Immunoseparation method - Slope | 0.94 | 1.09 |
| Correlation vs. Immunoseparation method - Intercept | +4.46 | -17.8 |
| Correlation vs. Immunoseparation method - r | 0.97 | 0.9728 |
Note: The acceptance criteria are implicitly derived from the performance of the predicate device (Genzyme N-geneous® LDL Cholesterol Reagent) as this is a 510(k) submission seeking substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Correlation vs. Reference method (Ultracentrifugation): n = 70
- Correlation vs. Immunoseparation method: n = 66
- Data Provenance: Not explicitly stated, but typically for such clinical testing, the data would be laboratory-generated. The document does not specify country of origin or whether it's retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The ground truth for the correlation studies was established by widely accepted laboratory methods (Ultracentrifugation and Immunoseparation method, and Friedewald calculation), not by expert consensus in the human interpretation sense.
4. Adjudication Method for the Test Set
This is not applicable as the studies are focused on comparing quantitative measurements from different assays, not on human interpretation or diagnosis requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This submission is for a diagnostic reagent, not an AI-assisted diagnostic device that involves human readers interpreting results.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable in the context of an "algorithm" as commonly used for AI. The study describes the standalone performance of the reagent (a chemical assay) by comparing its measurements to established reference methods.
7. The Type of Ground Truth Used
- Correlation vs. Reference Method: Ultracentrifugation
- Correlation vs. Immunoseparation Method: Immunoseparation method
- Correlation vs. Friedewald Calculation: Friedewald calculation
These methods are well-established laboratory techniques for determining LDL-C and serve as the ground truth or reference methods for comparison.
8. The Sample Size for the Training Set
This information is not provided. As this is a chemical reagent, it does not involve a "training set" in the machine learning sense. The development of the reagent would involve method optimization, but not a distinct "training set" of patient data in the same way an AI algorithm would.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for a chemical reagent. The development process would involve analytical chemistry and biochemistry principles to formulate the reagents to achieve the desired performance characteristics.
§ 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.