(43 days)
The Bayer Advia IMS B2-Microglobulin (B2M) assay is an in vitro diagnostic device intended to quantitatively measure ß2-Microglobulin in human serum and urine. When used in conjunction with clinical data and other diagnostic procedures, measurements of B2-Microglobulin aid in the management of patients with renal dysfunction and rheumatoid arthritis.
The Bayer Advia IMS Creatine Kinase (CKMB) assay is an in vitro diagnostic device intended to quantitatively measure the MB isoenzyme in human serum and plasma. When used in conjunction with other clinical data such as presenting symptoms and diagnostic procedures. measurements of CK-MB aid in the diagnosis of acute myocardial infarction (AMI).
The Bayer Advia IMS Myoglobin assay is an in vitro diagnostic device intended to quantitatively measure the myoglobin in human serum and plasma. When used in conjunction with other clinical data such as presenting symptoms and diagnostic procedures. measurements of myoglobin aid in the diagnosis of acute myocardial infarction (AMI).
The Bayer Advia IMS Testosterone assay is an in vitro diagnostic device intended to quantitatively measure total testosterone in human serum. Measurements of testosterone are used in the diagnosis and treatment of various hormonal sexual disorders. This diagnostic method is not intended for use on any other diagnostic system.
The Bayer Advia IMS Troponin I assay is an in vitro diagnostic device intended to quantitatively measure the cardiac Troponin I in human serum and plasma. When used in conjunction with other clinical data such as presenting symptoms and diagnostic procedures, measurements of cardiac Troponin I aid in the diagnosis of acute myocardial infarction (AMI).
The Bayer Advia IMS Ferritin assay is an in vitro diagnostic device intended to quantitatively measure ferritin (an iron-storage protein) in human serum. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency. This djagnostic method is not intended for use on any other diagnostic system.
The Bayer Advia IMS hCG assay is an in vitro diagnostic device intended to quantitatively measure total beta (B) human chorionic gonadotropin (hCG) in human serum, plasma, and urine. Measurements of human chorionic gonadotropin are used in the detection of pregnancy.
The Bayer Advia IMS TSH assay is an in vitro diagnostic device intended to quantitatively measure thyroid stimulating hormone (TSH) in human serum, plasma. This assay allows the determination of TSH with 3rd generation sensitivity of less than 20% total coefficient of variation (CV) at 0.01 to 0.02 mIU/L or uIU/mL, as defined by the American Thyroid Association. Measurements of thyroid stimulating hormone are used in the diagnosis of thyroid or pituitary disorders.
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The provided text describes several distinct in vitro diagnostic assays for the Bayer ADVIA® Integrated Modular System (IMS). Since each assay details its own performance criteria and study results, I will describe the acceptance criteria and study for one of the assays, the B2-Microglobulin (B2M) Assay, as an example.
B2-Microglobulin (B2M) Assay for Bayer ADVIA® Integrated Modular System (IMS)
The Bayer ADVIA® IMS B2-Microglobulin (B2M) assay is an in vitro diagnostic device intended to quantitatively measure β2-Microglobulin in human serum and urine. It aids in the management of patients with renal dysfunction and rheumatoid arthritis.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implied by the comparison to a predicate device (Immuno 1 B2-Microglobulin Assay) and are demonstrated through various analytical performance studies. The key performance metrics evaluated are Imprecision, Correlation, Analytical Range, Minimum Detectable Concentration (MDC), and Interference.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate/Industry Standard) | Reported Device Performance (ADVIA IMS B2M Assay) |
|---|---|---|
| Imprecision (Total CV%) | Comparable to or better than predicate; generally 0.95, slope near 1, intercept near 0). | Serum (N=86): Y = 1.009X + 0.055, Syx = 0.442 mg/L, R = 0.996 (vs. Immuno 1) |
| Urine (N=50): Y = 0.923X + 0.004, Syx = 0.012 mg/L, R = 0.990 (vs. Immuno 1) | ||
| Analytical Range | Clinically relevant range of measurement. | Serum: 0.001 – 20 mg/L |
| Urine: 0.001 – 10 mg/L | ||
| Minimum Detectable Concentration (MDC) | Low enough for clinical utility. | ADVIA IMS: 0.001 mg/L |
| Immuno 1 (Predicate): 0.01 mg/L | ||
| Interference (% change) | Generally, interference effects should be within a clinically acceptable limit (e.g., ±10% or ±15%). | Hemoglobin (1000 mg/dL): -6.18% |
| Lipids (Triglycerides, 1000 mg/dL): 4.68% | ||
| Bilirubin (25 mg/dL): 4.92% | ||
| Creatinine (2.5 mg/dL): -3.68% | ||
| Urea (200 mg/dL): 4.35% | ||
| Albumin (6500 mg/dL): 8.90% | ||
| Immunoglobulin (6000 mg/dL): 4.56% |
2. Sample Size Used for the Test Set and Data Provenance
The test sets for the correlation studies were:
- Serum: N = 86 samples
- Urine: N = 50 samples
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. However, given the context of laboratory analytical validation, these are typically prospective studies performed on collected human samples in a controlled laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
For this type of in vitro diagnostic device (quantitative assay), the "ground truth" for the test set is established by the measurement results from a legally marketed predicate device (Immuno 1 B2-Microglobulin Assay) or by established reference methods. While laboratory personnel with specific qualifications would perform these measurements, the concept of "experts" to establish ground truth in the sense of medical image interpretation (e.g., radiologists) is not applicable here. The accuracy of the predicate device itself serves as the benchmark.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used for qualitative or subjective assessments where multiple human readers disagree. For quantitative assays like this, the ground truth is established by the numerical result from the reference or predicate method. Therefore, no adjudication method in the traditional sense was used for the test set. Direct numerical comparison and statistical analysis (regression) are applied.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic imaging interpretation or other scenarios where human readers make subjective assessments that an AI might assist. This device is a fully automated quantitative assay, not involving human interpretation in the same way.
6. Standalone Performance Study
Yes, a standalone performance study was done for the ADVIA IMS B2-Microglobulin assay. The reported data for Imprecision, Analytical Range, Minimum Detectable Concentration, and Interference refer to the performance of the ADVIA IMS assay itself, independent of operator influence other than proper sample preparation and instrument operation. The correlation studies also demonstrate the standalone performance of the new device by comparing its output to the predicate device's output.
7. Type of Ground Truth Used
The ground truth used for performance evaluation, particularly for the correlation studies, was the results obtained from the predicate device, the Immuno 1 B2-Microglobulin Assay. This is a common approach for demonstrating substantial equivalence for new IVD assays. Other ground truths are inherent in the analytical methodologies used for imprecision, MDC, and interference studies which rely on known concentrations or spiked samples.
8. Sample Size for the Training Set
This document describes a cleared in vitro diagnostic assay, which is typically a chemical or immunoassay method, not a machine learning or AI-based device that requires a "training set" in the computational sense. Therefore, the concept of a "training set" sample size as it applies to AI/ML models is not applicable to this device. The development of such assays involves reagent formulation, optimization, and characterization, but not "training" on data in the way an algorithm is trained.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" does not apply to this type of traditional in vitro diagnostic assay. Therefore, there is no ground truth established for a training set. The development process involves chemical and biological engineering, not data-driven model training.
§ 866.5630
Beta -2-microglobulin immunological test system.(a)
Identification. Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.