(130 days)
The Apolipoprotein B assay is used for the quantitation of apolipoprotein B in human serum or plasma. Apolipoprotein B meaurements are useful in the diagnosis of premature coronary artery disease, hyper-b-lipoproteinemia, and hypo-b-lipoproteinemia.
Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum or plasma. Antibodies to apolipoprotein B combine with apolipoprotein B in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of apolipoprotein B in the sample.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Metric | Predicate Device (K-ASSAY® Apo B on Hitachi® 717 Analyzer) | Submitted Device (ApoB on AEROSET™ System) | Result/Performance | Acceptance Status |
|---|---|---|---|---|---|
| Method Comparison | Correlation Coefficient | N/A (Comparator) | N/A (Submitted Device) | 0.9793 | Met (Excellent) |
| Slope | N/A (Comparator) | N/A (Submitted Device) | 1.064 | Met (Close to 1) | |
| Y-intercept | N/A (Comparator) | N/A (Submitted Device) | -2.920 mg/dL | Met (Small value) | |
| Precision | Total %CV (Level 1) | N/A (No specific value given for predicate) | N/A (Submitted Device) | 2.5% | Met (Good) |
| Total %CV (Level 2) | N/A (No specific value given for predicate) | N/A (Submitted Device) | 1.8% | Met (Good) | |
| Assay Range | Quantitative Range | N/A (A difference noted, but no specific value for predicate) | N/A (Submitted Device) | 1.55 to 285.31 mg/dL | Met |
| Sensitivity | Limit of Quantitation | N/A (No specific value given for predicate) | N/A (Submitted Device) | 1.55 mg/dL | Met |
| Qualitative Equivalence | Similar clinical results | Yes | Yes | Achieved | Met |
| In Vitro Immunoassay | Yes | Yes | Achieved | Met | |
| Quantitative Determination | Yes | Yes | Achieved | Met | |
| Immune Complex Formation | Yes | Yes | Achieved | Met |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the comparative performance studies. It mentions "Comparative performance studies were conducted," but details on the number of samples are absent.
Regarding data provenance: The studies were conducted by Abbott Laboratories, in support of their submission to the FDA. The specific country of origin for the samples is not mentioned, nor is it explicitly stated whether the study was retrospective or prospective. Given the nature of a 510(k) submission for an in vitro diagnostic, these are typically laboratory-based studies using patient samples, but the exact details are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to an in vitro diagnostic assay like ApoB. "Ground truth" in this context refers to the established true value of apolipoprotein B in a sample. For diagnostic assays, the "ground truth" for the test set is typically established by using a reference method or a legally marketed predicate device, rather than expert consensus on images or clinical cases. In this case, the predicate device (K-ASSAY® Apo B on the Hitachi® 717 Analyzer) served as the defacto "ground truth" or comparator for the new device's performance.
4. Adjudication Method for the Test Set
Not applicable. As this is an in vitro diagnostic assay comparing performance against a predicate, there is no need for adjudication by human experts in the way it would be applied to, for example, image interpretation. The comparison is objective and quantitative.
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 devices that involve human interpretation, such as diagnostic imaging AI, where the impact of AI assistance on human reader performance is evaluated. The ApoB assay is an automated in vitro diagnostic test.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the study described is a standalone performance study of the ApoB assay. It assesses the assay's performance characteristics (correlation, precision, range, sensitivity) as an isolated device on the AEROSET™ System, comparing its results to those obtained from a predicate device. There is no human-in-the-loop component in the operation or result generation for this type of assay.
7. The Type of Ground Truth Used
The "ground truth" in this context is the results obtained from the legally marketed predicate device, the K-ASSAY® Apo B on the Hitachi® 717 Analyzer. The new device's measurements are compared directly to the measurements of this established and accepted method.
8. The Sample Size for the Training Set
No information regarding a "training set" or its sample size is provided. For an in vitro diagnostic assay like this, the development typically involves analytical validation studies rather than machine learning model training. The assay's parameters (e.g., reagent concentrations, reaction times) would be optimized during development, but this is not typically referred to as a "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a "training set" in the context of machine learning. The "ground truth" for developing such an assay would be based on established analytical chemistry principles, reference materials, and clinical validation against known patient samples, but these details are not provided in this summary.
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).