(212 days)
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.
§ 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).