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510(k) Data Aggregation
(220 days)
The Axis Homocysteine Enzyme Immunoassay is intended for the quantitative measurement of total L-homocysteine in human serum or plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocysteinuria.
The Axis Homocysteine Enzyme Immunoassay is designed for the quantitative determination of total homocysteine in plasma or serum. In the Axis Homocysteine Enzyme Immunoassay, protein bound homocysteine is reduced to free homocysteine, enzymatically converted to S-adenosyl-L-homocysteine (SAH), and detected in competitive immunoassay with monoclonal anti-SAH antibody.
The Axis Homocysteine Enzyme Immunoassay (Axis Homocysteine EIA) underwent an evaluation to establish its substantial equivalence to an existing device, the University of Bergen Homocysteine by HPLC method, and thus confirm its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied by Predicate Device Performance) | Axis Homocysteine Enzyme Immunoassay Performance |
|---|---|---|
| Precision | ||
| - Within-run %CV (Low) | Similar to or better than predicate | 7.3% |
| - Within-run %CV (Medium) | Similar to or better than predicate | 6.8% |
| - Within-run %CV (High) | Similar to or better than predicate | 5.2% |
| - Total precision (Low) | Similar to or better than predicate | 9.3% |
| - Total precision (Medium) | Similar to or better than predicate | 8.1% |
| - Total precision (High) | Similar to or better than predicate | 7.1% |
| Measuring Range | Not explicitly stated, but within clinically relevant range | 2 - 50 µmol/L |
| Limit of Quantification | Not explicitly stated, but clinically acceptable | < 0.5 µmol/L |
| Accuracy (Correlation to HPLC) | High correlation (r² close to 1, slope close to 1, Y-intercept close to 0) | r² = 0.94, Slope = 0.94, Y-Intercept = -0.09 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set used in the correlation study.
The study was a comparative study against the University of Bergen Homocysteine by HPLC method. The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective), but given the comparison to a specific university's method, it suggests samples were likely from a clinical setting where that method was in use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable for this type of device. The ground truth was established by a reference analytical method (HPLC), not through expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set
Not applicable. The "ground truth" was an analytical measurement from a reference method (HPLC). There was no human adjudication involved in this comparison study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of an in vitro diagnostic device, comparing its measurements to a reference method, not on human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the study primarily assessed the standalone performance of the Axis Homocysteine Enzyme Immunoassay. It's an in vitro diagnostic device, and its output is a quantitative measurement. The comparison was to another analytical method (HPLC), not to human interpretations.
7. The Type of Ground Truth Used
The ground truth used for performance evaluation (specifically accuracy) was the measurements obtained from a well-established and accepted reference method, the University of Bergen Homocysteine by HPLC method. This is considered an analytical gold standard for homocysteine quantification.
8. The Sample Size for the Training Set
The document does not provide details on a separate "training set" for the Axis Homocysteine EIA. Immunoassays are typically developed through a detailed R&D process involving reagent optimization, calibration, and validation, rather than a "training set" in the machine learning sense. The reported performance metrics (precision, measuring range, limit of quantification, and accuracy) appear to be derived from validation studies.
9. How the Ground Truth for the Training Set Was Established
Not explicitly described as a discrete "training set" in the context of machine learning. The development and calibration of the immunoassay would have relied on known concentrations of homocysteine, likely prepared using highly pure standards, to establish its measurement characteristics (e.g., standard curve for quantitative determination). These standards would effectively serve as the "ground truth" for the assay's development.
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