(60 days)
The Quantia Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or plasma (EDTA, Heparin, Citrate) on the Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation.
Quantia Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Quantia Lp(a) reagents by turbidimetry.
Quantia Lp(a) Standard is intended for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry.
The Quantia Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or plasma (EDTA, Heparin, Citrate) on the Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation.
Quantia Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Quantia Lp(a) reagents by turbidimetry.
Quantia Lp(a) Standard is intended for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry.
Here's an analysis of the provided text regarding the Quantia Lp(a) device, structured to address your specific points:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state pre-defined acceptance criteria for the Quantia Lp(a) device. Instead, it presents performance data and compares it to a predicate device to demonstrate substantial equivalence.
| Performance Metric | Reported Device Performance (Quantia Lp(a) vs Predicate) | Implicit Acceptance Criteria (based on predicate equivalence) |
|---|---|---|
| Method Comparison | ||
| Slope | 1.121 | Close to 1 (indicating proportional agreement) |
| Correlation Coeff. (r) | 0.9754 | High (indicating strong linear relationship) |
| Within-run Precision (CV) | ||
| Control Level 1 (mean 16.1 mg/dL) | 2.3% | Low CVs (indicating good reproducibility) |
| Control Level 2 (mean 57.9 mg/dL) | 0.9% | Low CVs (indicating good reproducibility) |
| Control Level 3 (mean 38.1 mg/dL) | 1.5% | Low CVs (indicating good reproducibility) |
Study to Prove Device Meets Acceptance Criteria:
The study proving the device meets the implicit acceptance criteria is a method comparison study and within-run precision assessment, detailed in the "Summary of Performance Data" section.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: 104 samples for the method comparison study.
- Data Provenance: Not explicitly stated, but originating from Biokit S.A. in Spain. The study compares the Quantia Lp(a) device to a predicate device, which implies the 104 samples were run on both systems. The document doesn't specify if the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The "ground truth" for the method comparison study was established by the predicate device (K013128 N-latex Lp(a) from Dade Behring).
- Qualifications of Experts: N/A, as expert consensus was not used to establish the ground truth.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. The comparison is directly to a predicate device, not against an adjudicated ground truth from multiple human readers.
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:
- MRMC Study: No, an MRMC study was not done. This device is an in-vitro diagnostic (IVD) assay, not an AI-powered image analysis tool or decision support system that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Yes, the performance data presented (method comparison and precision) represents the standalone performance of the Quantia Lp(a) assay system, as it's an automated immunoturbidimetric assay. There is no "human-in-the-loop" component in the direct measurement process.
7. The type of ground truth used:
- Type of Ground Truth: The "ground truth" for comparative effectiveness in this context is the results obtained from the predicate device, K013218 N-latex Lp(a) (Dade Behring).
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This document describes the validation of a laboratory assay, not a machine learning algorithm that requires a distinct training set. The assay's "training" or calibration would involve its own internal standards (Quantia Lp(a) Standard), not a separate dataset in the machine learning sense.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable in the machine learning sense. The Quantia Lp(a) Standard is used for establishing the calibration curve. The "ground truth" for these standards would have been established by the manufacturer through rigorous analytical methods (e.g., using reference materials and established metrological traceability) to determine their assigned values. This process is distinct from establishing ground truth for a machine learning training set.
§ 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).