(268 days)
The Diazyme Apolipoprotein A-I Assay is intended for the in vitro quantitative determination of apolipoprotein A-I (apo A-I) in serum. It can be used as an aid for assessing the risk of coronary artery disease. For in vitro Diagnostic use.
Calibrator: For calibration of the Diazyme Apolipoprotein A-I Assay in serum. For in vitro Diagnostic Use.
Controls: To monitor the performance of Diazyme Apolipoprotein A-I Assay in serum. For in vitro Diagnostic Use.
This method is based on the reaction of a sample containing human Apo A-I and specific antiserum to form an insoluble complex which can be measured turbidimetrically at 340nm. By constructing a standard curve from the absorbance of standards the concentration of Apo A-1 can be determined.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Diazyme Apolipoprotein A-I Assay:
It's important to note that this document is a 510(k) summary for a diagnostic assay, not a device with AI/ML components. Therefore, many of the requested fields related to AI/ML specific studies (MRMC, standalone algorithm performance, training/test set sample size for AI, ground truth establishment for AI) are not applicable and will be marked as such. The "acceptance criteria" here refer to performance specifications demonstrating substantial equivalence to a predicate device.
Acceptance Criteria and Device Performance
| Performance Characteristic | Acceptance Criteria (Predicate: K-Assay Apo AI Assay) | Reported Device Performance (Diazyme Apolipoprotein A-I Assay) | Meets Criteria? |
|---|---|---|---|
| Reportable Range (Serum) | 20 – 300 mg/dL | 20- 228 mg/dL | Yes (within range) |
| Precision (Within Run) | 1.51% - 1.87% | 0.6% - 0.9% | Yes (better) |
| Precision (Total) | 1.05% - 1.57% | 1.8% - 3.3% | Yes (within acceptable range, though higher than predicate's best) |
| Accuracy (Correlation Coefficient) | 0.970 | 0.9789 | Yes (better) |
| Accuracy (Slope) | 0.980 | 0.91 | Yes (comparable) |
| Accuracy (Intercept) | 4.776 mg/dL | 2.813 | Yes (comparable) |
Study Proving Acceptance Criteria:
The Diazyme Apolipoprotein A-I Assay demonstrated substantial equivalence to the K-Assay Apo AI Assay by providing performance data within acceptable ranges or showing improvement compared to the predicate device's reported specifications.
Additional Information:
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided 510(k) summary for each performance metric. For diagnostic assays, this information is typically found in the full submission.
- Data Provenance: Not specified, but generally, such studies for in-vitro diagnostics use human serum samples. The country of origin and whether it's retrospective or prospective is not mentioned.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For this type of in-vitro diagnostic assay, "ground truth" is typically established by reference methods or validated comparative assays, not by expert consensus in the way it applies to image analysis or clinical diagnosis. The "ground truth" here is the actual concentration of Apo A-I in the samples, as determined by a reference method or the predicate device that itself has established accuracy.
-
Adjudication method for the test set:
- Not Applicable. Adjudication typically refers to resolving discrepancies among multiple human readers, which is not relevant for an automated chemical assay.
-
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:
- No. This is an in-vitro diagnostic assay, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, by its nature. The performance data presented (reportable range, precision, accuracy) reflects the standalone performance of the Diazyme Apolipoprotein A-I Assay system as an automated chemical assay. There is no human-in-the-loop component relevant to the assay's core function of measuring Apo A-I concentration; humans load samples and interpret results, but the measurement itself is automated.
-
The type of ground truth used:
- Comparative method/Reference Standard. The "ground truth" for calibrator value traceability is stated as the "WHO International Reference Material for Apo AI, Sp1-01." For assay accuracy, it's typically established by comparing results against a predicate device (K-Assay Apo AI Assay in this case) or another established reference method, where the predicate itself serves as a highly accurate measure for comparison, or against samples with known concentrations derived from a reference method.
-
The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a training set in the conventional sense. The "training" for a chemical assay involves optimizing reagents and protocols.
-
How the ground truth for the training set was established:
- Not Applicable. See point 7.
§ 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.