(190 days)
The Bayer ADVIA 1650 Apolipoprotein A-1 (APO-A) assay is an in vitro diagnostic method intended to measure Apolipoprotein A-1 concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the assessment of risk for arteriosclerosis and coronary artery disease.
The Bayer ADVIA 1650 Apolipoprotein B (APO-B) assay is an in vitro diagnostic method intended to measure Apolipoprotein B concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the assessment of risk for arteriosclerosis and coronary artery disease.
The Bayer ADVIA 1650 Carbon Dioxide (CO2) assay is an in vitro fliagnostic method intended to measure Carbon Dioxide concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements obtained using this method assist in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
The Bayer ADVIA 1650 C-Reactive Protein (CRP) assay is an in vitro diagnostic method intended to measure C-Reactive Protein concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the evaluation of the amount of injury to body tissues. This test is useful in following the progress of rheumatic fever, rheumatoid arthritis, myocardial infarction, and malignancies.
The Bayer ADVIA 1650 Immunoglobulin A (IGA) assay is an in vitro diagnostic method intended to measure Immunoglobulin A (IGA) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents.
The Bayer ADVIA 1650 Immunoglobulin G (IGG) assay is an in vitro diagnostic method intended to measure Immunoglobulin G (IGG) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents.
The Bayer ADVIA 1650 Immunoglobulin M (IGM) assay is an in vitro diagnostic method intended to measure Immunoglobulin M (IGM) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents.
The Bayer ADVIA 1650 Transferrin (TFR) assay is an in vitro diagnostic device intended to measure Transferrin concentration in human serum and plasma on an Advia 1650 Chemistry System. Such measurements are used to aid in the diagnosis of malnutrition, chronic infection, acute hepatitis, polycythemia, pernicious anemia, and red blood cell disorders, such as iron deficiency anemia.
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The provided text describes the performance of the Bayer ADVIA 1650 device for eight different assays, comparing it to predicate devices. The studies establish the substantial equivalence of the ADVIA 1650 assays to already cleared devices.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state pre-defined "acceptance criteria" in terms of specific thresholds for Total CV%, Syx, or R values that the ADVIA 1650 must meet. Instead, the approach is one of demonstrating substantial equivalence to predicate devices. The reported performance metrics (Imprecision, Correlation, Interfering Substances, Analytical Range, and Expected Values) are provided for each assay, and the assumption is that these align with or are comparable to the performance of the predicate devices.
However, we can infer performance ranges based on the provided data for the ADVIA 1650 for each method. The "acceptance criteria" are implicitly met if the performance is deemed substantially equivalent to the predicate.
| Method | Performance Measure | ADVIA 1650 Reported Performance |
|---|---|---|
| Apolipoprotein A-1 | Imprecision (Total CV%) | 4.5% (low level), 4.1% (high level) (Serum) |
| Correlation (R) | 0.986 (vs. Behring, Serum), 0.996 (Plasma vs. Serum) | |
| Analytical Range | 15 mg/dL to Level 4 Calibrator | |
| Apolipoprotein B | Imprecision (Total CV%) | 5.7% (low level), 3.3% (high level) (Serum) |
| Correlation (R) | 0.993 (vs. Behring, Serum), 0.997 (Plasma vs. Serum) | |
| Analytical Range | 15 mg/dL to Level 4 Calibrator | |
| CO2 | Imprecision (Total CV%) | 6.7% (low level), 4.6% (high level) (Serum) |
| Correlation (R) | 0.963 (vs. DAX, Serum), 0.839 (Plasma vs. Serum) | |
| Analytical Range | 10-40 mEq/L | |
| CRP | Imprecision (Total CV%) | 13.6% (low level), 4.6% (high level) (Serum) |
| Correlation (R) | 0.984 (vs. Behring, Serum) | |
| Analytical Range | 5 mg/L to Level 5 Calibrator | |
| IgA | Imprecision (Total CV%) | ~2% (both levels) (Serum) |
| Correlation (R) | 0.997 (vs. Behring, Serum), 0.986 (EDTA Plasma vs. Serum), 0.975 (Heparin Plasma vs. Serum) | |
| Analytical Range | 15 mg/dL to Level 5 Calibrator | |
| IgG | Imprecision (Total CV%) | 2.4% (low level), 1.7% (high level) (Serum) |
| Correlation (R) | 0.999 (vs. Behring, Serum), 0.974 (EDTA Plasma vs. Serum), 0.962 (Heparin Plasma vs. Serum) | |
| Analytical Range | 85 mg/dL to Level 5 Calibrator | |
| IgM | Imprecision (Total CV%) | 7.4% (low level), 3.7% (high level) (Serum) |
| Correlation (R) | 0.98 (vs. Behring, Serum), 0.989 (EDTA Plasma vs. Serum), 0.982 (Heparin Plasma vs. Serum) | |
| Analytical Range | 12 mg/dL to Level 5 Calibrator | |
| Transferrin | Imprecision (Total CV%) | 4.7% (low level), 3.7% (high level) (Serum) |
| Correlation (R) | 0.976 (vs. Behring, Serum), 0.993 (EDTA Plasma vs. Serum), 0.987 (Heparin Plasma vs. Serum) | |
| Analytical Range | Level 1 Calibrator to Level 5 Calibrator |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Sizes (N for Correlation sections):
- Apolipoprotein A-1: 78 (Serum: ARI), 72 (Plasma vs. Serum)
- Apolipoprotein B: 59 (Serum: Tarrytown), 71 (Plasma vs. Serum)
- CO2: 146 (Serum: Tarrytown), 79 (Plasma vs. Serum)
- CRP: 56 (Serum: Tarrytown)
- IgA: 74 (Serum: Tarrytown), 68 (EDTA Plasma vs. Serum), 69 (Heparin Plasma vs. Serum)
- IgG: 60 (Serum: Tarrytown), 72 (EDTA Plasma vs. Serum), 73 (Heparin Plasma vs. Serum)
- IgM: 74 (Serum: Tarrytown), 69 (EDTA Plasma vs. Serum), 70 (Heparin Plasma vs. Serum)
- Transferrin: 78 (Serum: Tarrytown), 71 (EDTA Plasma vs. Serum), 72 (Heparin Plasma vs. Serum)
- Data Provenance: The studies were conducted at specific sites, primarily "Tarrytown" and "ARI." Based on the address provided for Bayer Corporation (Tarrytown, NY), the data provenance is likely United States. The document does not specify if the data was retrospective or prospective, but clinical correlation/imprecision studies for IVD devices are typically prospective or involve freshly collected samples for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this type of in vitro diagnostic device study. The "ground truth" for the test set is established by the predicate device's measurement. These are quantitative assays, and the comparison is made against existing, cleared methods, not against expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no human interpretation or adjudication involved in establishing truth for quantitative chemical assays comparing a new device to a predicate.
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
Not applicable. This is not an AI-assisted diagnostic imaging device. It's an in vitro diagnostic chemistry system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are standalone performance evaluations of the ADVIA 1650 device. The data provided (imprecision, correlation, interference) reflects the performance of the instrument and its reagents in measuring the specified analytes without direct human-in-the-loop diagnostic decisions being evaluated. The overall clinical utility is described in the "Intended Use" and "Expected Values" sections, assuming trained laboratory personnel operate the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the correlation studies, the measurements from the predicate devices (e.g., Behring Nephelometer, Technicon DAX) served as the "comparison system" or reference for the ADVIA 1650 device. The predicate devices themselves would have established their accuracy and precision through their own clinical validation processes.
8. The sample size for the training set
The document does not explicitly state a "training set" size. For IVD devices, method validation studies typically involve method development and optimization (analogous to training) followed by performance verification (the studies reported here). The specific sample numbers used for developing the assays and optimizing parameters are not detailed in this summary. The sample sizes listed in point 2 are for the performance verification/test set studies.
9. How the ground truth for the training set was established
As with the test set, the ground truth for any internal method development (if "training set" refers to samples used during that phase) would rely on reference methods or established laboratory standards for accurate analyte quantification. The document doesn't provide details on the specific "ground truth" establishment for method development. The focus is on demonstrating equivalence to legally marketed predicate devices.
§ 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.