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510(k) Data Aggregation
(92 days)
AXIS BIOCHEMICALS, ASA
The IMx® Homocysteine assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of total Lhomocysteine in human serum or plasma on the IMx Analyzer. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
IMx Homocysteine is a Fluorescence Polarization Immunoassay for the quantitative measurement of total L-homocysteine in human serum or plasma on the IMx Analyzer.
Here's a breakdown of the acceptance criteria and study information for the IMx Homocysteine assay based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format. Instead, it demonstrates interchangeability by comparing the IMx Homocysteine assay to a legally marketed predicate device (the University of Bergen Homocysteine HPLC method). The performance is reported in terms of correlation and agreement with this predicate device.
| Performance Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (IMx Homocysteine vs. Bergen HPLC Method) |
|---|---|---|
| Correlation Coefficient | Strong correlation (e.g., >0.95) | 0.989 |
| Slope | Close to 1 (e.g., 0.95 - 1.05) | 0.980 |
| Y-intercept | Close to 0 | 0.12 umol/L |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 114 specimens
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense that it uses existing specimens to compare a new method to an existing one. However, it doesn't specify if these were newly collected for the study or historical samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The "ground truth" for this study is the measurement obtained from the predicate device (Bergen HPLC method), not an expert consensus on a clinical condition.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used when human readers or clinicians are interpreting results, and there's a need to resolve discrepancies. In this case, the reference is a laboratory measurement from another assay.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study is an analytical performance comparison between two diagnostic assays, not a study involving human readers' performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance evaluation was done. The IMx Homocysteine assay's performance was directly compared to the Bergen HPLC method without human intervention in the result generation or interpretation for the comparison itself. The assay provides a quantitative measurement.
7. The Type of Ground Truth Used
The ground truth for the comparison study was the measurements obtained from a legally marketed and established predicate device: the University of Bergen Homocysteine HPLC method. This method itself was shown to be equivalent to amino acid analysis for homocysteine detection.
8. The Sample Size for the Training Set
This information is not provided. The document describes a comparison study for substantial equivalence, not the development or training of the IMx Homocysteine assay. Immunoassays like this do not typically have "training sets" in the same way machine learning algorithms do; their calibration and performance are established through analytical validation.
9. How the Ground Truth for the Training Set Was Established
This information is not provided/not applicable for the reasons mentioned above. For an immunoassay, the "ground truth" for calibration would typically be established through highly purified standards of homocysteine with known concentrations.
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(220 days)
AXIS BIOCHEMICALS, ASA
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 |
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(212 days)
AXIS BIOCHEMICALS, ASA
The IMx Homocysteine assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of total L-homocysteine in human serum or plasma on the IMx Analyzer. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
IMx Homocysteine is a Fluorescence Polarization Immunoassay for the quantitative measurement of total L-homocysteine in human serum or plasma on the IMx Analyzer. IMx Homocysteine is calibrated with IMx Homocysteine Calibrators. IMx Homocysteine Controls are assayed for the verification of the accuracy and precision of the Abbott IMx Analyzer.
Here's an analysis of the provided information about the IMx® Homocysteine device, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Correlation with Predicate Device (Bergen HPLC method) | Correlation Coefficient: 0.989 |
| Slope of Regression (IMx vs. Bergen HPLC) | Slope: 0.980 |
| Y-intercept of Regression (IMx vs. Bergen HPLC) | Y-intercept: 0.12 umol/L |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 114 specimens
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for the test set. Instead, it compares the IMx Homocysteine assay to an existing, validated analytical method (the University of Bergen Homocysteine HPLC method), which serves as the reference standard.
4. Adjudication Method for the Test Set
Not applicable. The study compares a new analytical method to an established reference method, rather than involving human interpretation that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is for an in vitro diagnostic device (IVD) based on a quantitative immunoassay, not an imaging device or a device that involves human interpretation of results in a diagnostic setting in the typical sense of an MRMC study.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was performed. The IMx Homocysteine assay's performance was evaluated by directly comparing its quantitative measurements against the Bergen HPLC method on human serum or plasma specimens.
7. Type of Ground Truth Used
The ground truth used was the quantitative measurement of total L-homocysteine obtained from a reference analytical method: the University of Bergen Homocysteine HPLC method. This method was already established and shown to be equivalent to amino acid analysis for homocysteine detection.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of device development. This is typical for an immunoassay where the "training" (calibration) is usually managed through a set of calibrators provided with the assay itself, rather than a separate large-scale data training process as seen in machine learning algorithms. The 114 specimens were used for the comparative evaluation study.
9. How the Ground Truth for the Training Set Was Established
As noted in section 8, the concept of a "training set" for ground truth establishment, in the sense of AI/ML, is not directly applicable here. The IMx Homocysteine assay is calibrated using "IMx Homocysteine Calibrators," and its accuracy and precision are verified using "IMx Homocysteine Controls." The ground truth for these calibrators and controls would have been established through robust analytical validation processes, likely against highly accurate reference methods, but the specifics are not detailed in this summary.
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