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510(k) Data Aggregation
(135 days)
BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM
The Bayer Advia IMS C-Reactive Protein (CRP) assay is an in vitro diagnostic device into ded to measure C-Reactive Protein in human serum. Measurements of CRP are used in the evaluation and treatment on injuries to body tissues and in monitoring the progress of traumatic injuries, rheumatic fever and rheumatoid arthritis.
This in vitro method is intended to quantitatively measure C-reactive protein (CRP) in serum on the Bayer ADVIA IMS systems.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the ADVIA IMS High Sensitivity C-Reactive Protein (CRP) Method based on the 510(k) summary:
Acceptance Criteria and Device Performance for ADVIA IMS High Sensitivity C-Reactive Protein (CRP) Method
This device intends to quantitatively measure C-reactive protein (CRP) in serum, primarily for evaluating and treating tissue injuries and monitoring traumatic injuries, rheumatic fever, and rheumatoid arthritis. The study compares the performance of the ADVIA IMS CRP assay against a predicate device, the Dade/Behring N High Sensitivity CRP (K991385).
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this diagnostic device are typically established by demonstrating substantial equivalence to a legally marketed predicate device, focusing on analytical performance characteristics such as imprecision, correlation, and interference.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA IMS CRP) |
|---|---|---|
| Imprecision (Normal Range) | ||
| Level 1 (16.5 mg/L) | Total CV |
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(66 days)
BAYER ADVIA IMS SYSTEM
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(57 days)
BAYER ADVIA IMS SYSTEM; 200 + 3
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(58 days)
ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
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(147 days)
BAYER ADVIA IMS SYSTEM
The Bayer Advia IMS Direct Bilirubin assay is an in virro diagnostic device intended to measure conjugated bilirubin in human serum or plasma. Measurements of direct or total bilirubin organic compounds formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis, monitoring and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder disorders.
The Bayer Advia IMS Hemoglobin A1c (HbA1c) method is an in vitro diagnostic device intended to measure Hemoglobin A1c, a diabetes marker, in human blood. Measurements of HbAlc can bc used for monitoring the long term care of persons with diabetes. The HbAlc and total hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA 1c/THb ratio, and must not be used individually for diagnostic purposes.
The Bayer Advia IMS Gentamicin assay is an in vitro diagnostic device intended to measure gentamicin, an antibiotic drug, in human serum. Measurements of gentamicin are used as an aid in the diagnosis and treatment of gentamicin overdose and in monitoring therapeutic levels of gentamicin to ensure appropriate therapy.
The Bayer Advia IMS Magnesium method is an in vitro diagnostic device intended to measure magnesium in human serum, plasma or urine. Measurements of magnesium are used in the diagnosis and treatment of hypomagnesemia, hypermagnesemia and monitoring of patients receiving prolonged magnesium-free intravenous therapv.
The Bayer Advia IMS Theophylline assay is an in vitro diagnostic device intended to measure theophylline in human serum. Measurements of theophyllinc arc used as an aid in the diagnosis and treatment theophylline overdose and in monitoring therapeutic levels of theophylline to ensure appropriate therapy.
The Bayer Advia IMS Tobramvoin assay is an in vitro diagnostic device intended to quantitatively measure tobramycin, an antibiotic drug, human serum. Measurements of tobramycin are used in the diagnosis and treatment of tobramycin overdose and in monitoring therapeutic levels of tobramycin to ensure appropriate therapy.
The Bayer Advia IMS Uric Acid (UA) method is an in vitro diagnostic device intended to measure uric acid in human serum, plasma, and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, and of patients receiving cytotoxic drugs.
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Here's a breakdown of the acceptance criteria and supporting studies for each of the devices mentioned in the provided 510(k) summaries. It's important to note that these documents are primarily for demonstrating substantial equivalence to a predicate device, which often means showing comparable performance rather than setting strict, pre-defined "acceptance criteria" against an absolute standard. The "reported device performance" is essentially the data presented to demonstrate this equivalence.
For all devices, the data provenance is assumed to be retrospective as these are 510(k) summaries, typically presented after studies have been completed. The country of origin for the data is not explicitly stated but can be inferred as the "Bayer Corporation, Business Group Diagnostics Tarrytown, NY" is the submitter.
General Caveats for all devices:
- Sample Size for Training Set: The documents do not provide information on the sample size or ground truth establishment for any training sets. This is typical for 510(k) summaries of in vitro diagnostic assays, which often focus on analytical performance rather than machine learning algorithm development.
- Number of Experts & Qualifications / Adjudication Method / MRMC Comparative Effectiveness Study / Standalone Performance: These concepts are not applicable to the analytical performance testing of in vitro diagnostic assays described in these summaries. These are typically relevant for image-based diagnostic AI/ML devices where reader interpretation is a key component. The "ground truth" for these assays is the reference method's result, or values from a highly characterized reference material.
1. Direct Bilirubin method for ADVIA® 400 (K993867)
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA 400) |
|---|---|---|
| Imprecision (CV%) | Level 0.7 mg/dL: 9.0% CV | |
| Level 0.7-1.0 mg/dL | Similar to predicate (e.g., 0.95) | 0.994 |
| Sample Range | Appropriate for clinical use | 0.0 - 10.6 mg/dL |
| Matrix Comparison (Plasma vs. Serum) | ||
| Regression Equation (Y=Plasma, X=Serum) | Slope close to 1, Intercept close to 0 | Y=0.89X+0.06 |
| Syx (mg/dL) | Low | 0.03 |
| r (correlation coefficient) | Close to 1 | 0.852 |
| Sample Range | Appropriate for clinical use | 0.09 - 0.42 mg/dL |
| Interference | Minimal clinical impact | Hemoglobin (500 mg/dL): -17% effect @ 0.9 mg/dL D. Bilirubin |
| Lipids (Triglycerides 500 mg/dL): -69% effect @ 1.8 mg/dL D. Bilirubin | ||
| Analytical Range | Clinically relevant | 0 to 14 mg/dL |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Sizes:
- Imprecision (CV%): Not explicitly stated, typically involves replicate measurements of controls or pooled samples.
- Correlation (Serum vs. CHEM 1): N=59
- Correlation (Plasma vs. Serum): N=59
- Interfering Substances: Not explicitly stated, typically involves a few samples spiked with interferents.
- Data Provenance: Retrospective, country of origin not explicitly stated (implied USA).
7. The type of ground truth used
- Imprecision: Measured value from the ADVIA 400 system itself, demonstrating repeatability.
- Correlation: The comparison system (Technicon CHEM 1) is used as the reference/ground truth for the test.
- Interfering Substances: The true concentration of D. Bilirubin in the sample prior to adding the interferent.
- Analytical Range: Established by demonstrating linearity and acceptable recovery across the stated range, with reference materials or spiked samples.
2. HbA1c Method for ADVIA IMS
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Minimum Detectable Concentration (MDC) | Lower than or comparable to predicate | 0.61% |
| Imprecision (CV%) | Level 5.71%: 5.4% CV | |
| Level 4.6-5.71% | Similar to predicate (e.g., 0.95) | 0.991 |
| Sample Range | Appropriate for clinical use | 5.09 - 17.21 % |
| Interference | Minimal clinical impact | Bilirubin (unconjugated 25 mg/dL): -1% effect |
| Bilirubin (conjugated 20 mg/dL): -2% effect | ||
| Urea (500 mg/dL): +4% effect | ||
| Lipids (Triglycerides 1000 mg/dL): -4% effect | ||
| Analytical Range | Clinically relevant | 0.61 to 17.2% |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Sizes:
- MDC: Not explicitly stated, typically involves multiple measurements of low-concentration samples.
- Imprecision (CV%): Not explicitly stated, usually multiple replicates across different runs/days.
- Correlation (Serum vs. RA-1000): N=57
- Interfering Substances: Not explicitly stated.
- Data Provenance: Retrospective, country of origin not explicitly stated (implied USA).
7. The type of ground truth used
- MDC: Determined by statistical analysis of repeat measurements of blank or low-level samples.
- Imprecision: Measured value from the ADVIA IMS system itself.
- Correlation: The comparison system (Bayer RA-1000 HbAlc) is used as the reference/ground truth.
- Interfering Substances: The true concentration of HbA1c in the sample prior to adding the interferent.
- Analytical Range: Established using materials with known HbA1c concentrations.
3. Gentamicin Method for ADVIA® IMS
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Minimum Detectable Concentration (MDC) | Lower than or comparable to predicate | 0.06 µg/mL |
| Imprecision (CV%) | Level 1.79 µg/mL: 7.2% CV | |
| Level 1.79-3.20 µg/mL | Similar to predicate (e.g., 0.95) | 0.989 |
| Sample Range | Appropriate for clinical use | 0.5 - 11.5 µg/mL |
| Interference | Minimal clinical impact | Bilirubin (unconjugated 25 mg/dL): +3% effect |
| Bilirubin (conjugated 20 mg/dL): +3% effect | ||
| Hemoglobin (600 mg/dL): -4% effect | ||
| Lipids (Triglycerides 1000 mg/dL): +4% effect | ||
| Analytical Range | Clinically relevant | 0.06 to 16.0 µg/mL |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Sizes:
- MDC: Not explicitly stated.
- Imprecision (CV%): Not explicitly stated.
- Correlation (Serum vs. Immuno 1): N=54
- Interfering Substances: Not explicitly stated.
- Data Provenance: Retrospective, country of origin not explicitly stated (implied USA).
7. The type of ground truth used
- MDC: Determined by statistical analysis of repeat measurements of blank or low-level samples.
- Imprecision: Measured value from the ADVIA IMS system itself.
- Correlation: The comparison system (Bayer Immuno 1 Gentamicin) is used as the reference/ground truth.
- Interfering Substances: The true concentration of Gentamicin in the sample prior to adding the interferent.
- Analytical Range: Established using materials with known Gentamicin concentrations.
4. Magnesium method for ADVIA® IMS
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Imprecision (Serum CV%) | Level 1.76 mg/dL: 2.4% CV | |
| Level 1.6-1.76 mg/dL | Similar to predicate (e.g., 0.95) | 0.991 |
| Sample Range | Appropriate for clinical use | 4.1 - 39.6 µg/mL |
| Interference | Minimal clinical impact | Bilirubin (unconjugated 25 mg/dL): +6% effect |
| Bilirubin (conjugated 15 mg/dL): +7% effect | ||
| Hemoglobin (600 mg/dL): -4% effect | ||
| Lipids (Triglycerides 1000 mg/dL): -6% effect | ||
| Analytical Range | Clinically relevant | 0.47 to 40 µg/mL |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Sizes:
- MDC: Not explicitly stated.
- Imprecision (CV%): Not explicitly stated.
- Correlation (Serum vs. RA-1000): N=51
- Interfering Substances: Not explicitly stated.
- Data Provenance: Retrospective, country of origin not explicitly stated (implied USA).
7. The type of ground truth used
- MDC: Determined by statistical analysis of repeat measurements of blank or low-level samples.
- Imprecision: Measured value from the ADVIA IMS system itself.
- Correlation: The comparison system (Bayer RA-1000 Theophylline) is used as the reference/ground truth.
- Interfering Substances: The true concentration of Theophylline in the sample prior to adding the interferent.
- Analytical Range: Established using materials with known Theophylline concentrations.
6. Tobramycin Method for ADVIA® IMS
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Minimum Detectable Concentration (MDC) | Lower than or comparable to predicate | 0.34 µg/mL |
| Imprecision (CV%) | Level 1.92 µg/mL: 4.3% CV | |
| Level 1.15-1.92 µg/mL | Similar to predicate (e.g., 0.95) | 0.997 |
| Sample Range | Appropriate for clinical use | 0.3 - 11.5 µg/mL |
| Interference | Minimal clinical impact | Bilirubin (unconjugated 25 mg/dL): +6% effect |
| Bilirubin (conjugated 20 mg/dL): +3% effect | ||
| Hemoglobin (600 mg/dL): 0% effect | ||
| Lipids (Triglycerides 1000 mg/dL): -1% effect | ||
| Analytical Range | Clinically relevant | 0.34 to 16.0 µg/mL |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Sizes:
- MDC: Not explicitly stated.
- Imprecision (CV%): Not explicitly stated.
- Correlation (Serum vs. Immuno 1): N=69
- Interfering Substances: Not explicitly stated.
- Data Provenance: Retrospective, country of origin not explicitly stated (implied USA).
7. The type of ground truth used
- MDC: Determined by statistical analysis of repeat measurements of blank or low-level samples.
- Imprecision: Measured value from the ADVIA IMS system itself.
- Correlation: The comparison system (Bayer Immuno 1 Tobramycin) is used as the reference/ground truth.
- Interfering Substances: The true concentration of Tobramycin in the sample prior to adding the interferent.
- Analytical Range: Established using materials with known Tobramycin concentrations.
7. Uric Acid method for ADVIA® IMS
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Imprecision (Serum CV%) | Level 3.68 mg/dL: 3.6% CV | |
| Level 3.68-3.8 mg/dL | Similar to predicate (e.g., |
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(43 days)
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS
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.
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(155 days)
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
The Bayer ADVIA IMS C3 assay is an in vitro diagnostic device intended to measure Complement C3 (C3) in human serum. Such measurements are used as an aid in the diagnosis and treatment of immunologic disorders.
The Bayer ADVIA IMS C4 assay is an in vitro diagnostic device intended to measure Complement C4 (C4) in human serum. Such measurements are used as an aid in the diagnosis and treatment of immunologic disorders.
The Bayer ADVIA IMS IgA assay is an in vitro diagnostic device intended to measure Immunoglobulin A (IgA) in human serum. Such measurements are used as an aid in the diagnosis and treatment of abnormal protein metabolism and the body's inability to resist infectious agents.
The Bayer ADVIA IMS IgG assay is an in vitro diagnostic device intended to measure Immunoglobulin G (IgG) in human serum. Such measurements are used as an aid in the diagnosis and treatment of autoimmune diseases, chronic or recurrent infections and abnormal protein metabolism.
The Bayer ADVIA IMS Immunoglobulin M (IgM) assay is an in vitro diagnostic device intended to measure IgM in human serum. Such measurements are used as an aid in the diagnosis and treatment of chronic or recurrent infections and abnormal protein metabolism.
The Bayer ADVIA IMS Transferrin assay is an in vitro diagnostic device intended to measure transferrin (TRF) in human serum. Such measurements are used as an aid in the diagnosis and treatment of malnutrition, chronic infection, acute hepatitis, polycythemia, pernicious anemia, and red blood cell disorders, such as iron deficiency anemia.
The Bayer ADVIA IMS Vancomycin assay is an in vitro diagnostic device intended to measure vancomycin, an antibiotic drug, in human serum. Measurements of vancomycin are used as an aid in the diagnosis and treatment of vancomycin overdose and in monitoring therapeutic levels of vancomycin to ensure appropriate therapy.
The Bayer ADVIA IMS Valproic Acid Assay is an in vitro diagnostic device intended to measure valproic acid, an anti-epileptic drug, in human serum. Measurements of valproic acid are used as an aid in the diagnosis and treatment of valproic acid overdose and in monitoring therapeutic levels of valproic acid to ensure appropriate therapy.
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The provided text describes several immunoassay methods for the Bayer ADVIA IMS Systems, focusing on their performance compared to predicate devices. It does not explicitly state "acceptance criteria" for each test but rather presents performance data (precision, correlation, analytical range, interference) alongside a predicate device's performance. The study aims to demonstrate substantial equivalence to these predicate devices for FDA clearance.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Since explicit acceptance criteria are not stated, I will infer them as the performance of the predicate device (the "similar device that was granted clearance of substantial equivalence") for correlation and precision, and generally acceptable performance within an analytical range with minimal interference. The reported device performance is that of the ADVIA IMS method.
| Metric (Implied Acceptance Criterion: Predicate Performance) | ADVIA IMS (Reported Performance) |
|---|---|
| C3 Method (Predicate: Dade Behring BNA Complement C3 method) | |
| Precision (Total) @ 72.4 mg/dL | 2.1% @ 79.7 mg/dL (Predicate: 5.9%) |
| Precision (Total) @ 237 mg/dL | 1.8% @ 154 mg/dL (Predicate: 2.1%) |
| Correlation (y=0.92x + 9.7, r=0.972, Syx=12.1 mg/dL) | Matched to Predicate |
| Interfering Substances: Bilirubin unconjugated (20 mg/dL) at 106 mg/dL C3 | +1% Change (Predicate: Not specified, but implied acceptable for clearance) |
| Interfering Substances: Bilirubin conjugated (20 mg/dL) at 113 mg/dL C3 | +4% Change (Predicate: Not specified) |
| Interfering Substances: Hemoglobin (500 mg/dL) at 114 mg/dL C3 | -2% Change (Predicate: Not specified) |
| Interfering Substances: Triglycerides (1000 mg/dL) at 107 mg/dL C3 | -8% Change (Predicate: Not specified) |
| Analytical Range (Normal: 27-360 mg/dL) | Matched to Predicate |
| C4 Method (Predicate: Dade Behring BNA Complement C4 method) | |
| Precision (Total) @ 15.7 mg/dL | 1.9% @ 19.3 mg/dL (Predicate: 2.9%) |
| Precision (Total) @ 34.8 mg/dL | 2.0% @ 34.8 mg/dL |
| Precision (Total) @ 49.3 mg/dL | 1.9% @ 49.3 mg/dL |
| Correlation (y=0.92x - 0.3, r=0.989, Syx=1.9 mg/dL) | Matched to Predicate |
| Interfering Substances: Bilirubin unconjugated (20 mg/dL) at 19 mg/dL C4 | 0% Change (Predicate: Not specified) |
| Interfering Substances: Bilirubin conjugated (20 mg/dL) at 21 mg/dL C4 | 0% Change (Predicate: Not specified) |
| Interfering Substances: Hemoglobin (500 mg/dL) at 20 mg/dL C4 | 0% Change (Predicate: Not specified) |
| Analytical Range (Normal: 7.2-96 mg/dL) | Matched to Predicate |
| IgA Method (Predicate: Dade Behring BNA Immunoglobulin A method) | |
| Precision (Total) @ 296 mg/dL | 2.3% @ 122 mg/dL (Predicate: 3.5%) |
| Precision (Total) @ 233 mg/dL | 1.6% @ 233 mg/dL |
| Precision (Total) @ 344 mg/dL | 1.4% @ 344 mg/dL |
| Correlation (y=1.00x - 1, r=0.994, Syx=75.6 mg/dL) | Matched to Predicate |
| Interfering Substances: Bilirubin unconjugated (20 mg/dL) at 180 mg/dL IgA | +2% Change (Predicate: Not specified) |
| Interfering Substances: Bilirubin conjugated (20 mg/dL) at 200 mg/dL IgA | -3% Change (Predicate: Not specified) |
| Interfering Substances: Hemoglobin (500 mg/dL) at 191 mg/dL IgA | +1% Change (Predicate: Not specified) |
| Interfering Substances: Triglycerides (1000 mg/dL) at 184 mg/dL IgA | -8% Change (Predicate: Not specified) |
| Analytical Range (Normal: 45-600 mg/dL) | Matched to Predicate |
| IgG Method (Predicate: Dade Behring BNA Immunoglobulin G method) | |
| Precision (Total) @ 2141 mg/dL | 1.8% @ 772 mg/dL (Predicate: 3.4%) |
| Precision (Total) @ 1317 mg/dL | 2.7% @ 1317 mg/dL |
| Precision (Total) @ 1416 mg/dL | 1.6% @ 1416 mg/dL |
| Correlation (y=0.97x - 3, r=0.994, Syx=118 mg/dL) | Matched to Predicate |
| Interfering Substances: Bilirubin unconjugated (20 mg/dL) at 876 mg/dL IgG | -3.0% Change (Predicate: Not specified) |
| Interfering Substances: Bilirubin conjugated (20 mg/dL) at 953 mg/dL IgG | -3.0% Change (Predicate: Not specified) |
| Interfering Substances: Hemoglobin (500 mg/dL) at 897 mg/dL IgG | +7.0% Change (Predicate: Not specified) |
| Interfering Substances: Triglycerides (1000 mg/dL) at 887 mg/dL IgG | -3.0% Change (Predicate: Not specified) |
| Analytical Range (Normal: 225-3000 mg/dL) | Matched to Predicate |
| IgM Method (Predicate: Dade Behring BNA Immunoglobulin M method) | |
| Precision (Total) @ 69.0 mg/dL | 3.6% @ 69.0 mg/dL (Predicate: 2.4% @ 128 mg/dL) |
| Precision (Total) @ 117 mg/dL | 1.9% @ 117 mg/dL |
| Precision (Total) @ 128 mg/dL | 2.4% @ 128 mg/dL |
| Precision (Total) @ 177 mg/dL | 1.5% @ 177 mg/dL |
| Correlation (y=1.05x - 13.4, r=0.990, Syx=123.5 mg/dL) | Matched to Predicate |
| Interfering Substances: Bilirubin unconjugated (20 mg/dL) at 77 mg/dL IgM | +3.9% Change (Predicate: Not specified) |
| Interfering Substances: Bilirubin conjugated (10 mg/dL) at 85 mg/dL IgM | +1.2% Change (Predicate: Not specified) |
| Interfering Substances: Hemoglobin (500 mg/dL) at 86 mg/dL IgM | 0.0% Change (Predicate: Not specified) |
| Analytical Range (Normal: 30-400 mg/dL) | Matched to Predicate |
| TRF Method (Predicate: Dade Behring BNA Transferrin method) | |
| Precision (Total) @ 127 mg/dL | 2.2% @ 127 mg/dL (Predicate: 2.7% @ 303 mg/dL) |
| Precision (Total) @ 303 mg/dL | 2.7% @ 303 mg/dL |
| Precision (Total) @ 268 mg/dL | 1.9% @ 268 mg/dL |
| Precision (Total) @ 400 mg/dL | 3.1% @ 400 mg/dL |
| Correlation (y=0.96x - 3, r=0.979, Syx=16.8 mg/dL) | Matched to Predicate |
| Interfering Substances: Bilirubin unconjugated (20 mg/dL) at 212 mg/dL TRF | +2% Change (Predicate: Not specified) |
| Interfering Substances: Bilirubin conjugated (20 mg/dL) at 231 mg/dL TRF | 0% Change (Predicate: Not specified) |
| Interfering Substances: Hemoglobin (500 mg/dL) at 261 mg/dL TRF | 0% Change (Predicate: Not specified) |
| Interfering Substances: Triglycerides (1000 mg/dL) at 215 mg/dL TRF | -4% Change (Predicate: Not specified) |
| Analytical Range (Normal: 54-720 mg/dL) | Matched to Predicate |
| Vancomycin Method (Predicate: Bayer Immuno 1 Vancomycin method) | |
| Analytical Range | 0.4-50 µg/mL (Predicate: Not explicitly stated, but implied similar operating range) |
| Precision (Total) @ 6.7 µg/mL | 2.8% @ 8.6 µg/mL (Predicate: 8.9%) |
| Precision (Total) @ 23.3 µg/mL | 3.4% @ 21.5 µg/mL (Predicate: 7.5%) |
| Precision (Total) @ 32.4 µg/mL | 3.9% @ 35.8 µg/mL (Predicate: 8.1%) |
| Correlation (y=1.02x + 0.68, r=0.987, Syx=1.6 µg/dL) | Matched to Predicate |
| Interfering Substances: Bilirubin unconjugated (25 mg/dL) at 15.3 µg/mL Vanco | +0.3% Change (Predicate: Not specified) |
| Interfering Substances: Bilirubin conjugated (25 mg/dL) at 15.9 µg/mL Vanco | +0.6% Change (Predicate: Not specified) |
| Interfering Substances: Hemoglobin (1000 mg/dL) at 16.1 µg/mL Vanco | -7.7% Change (Predicate: Not specified) |
| Interfering Substances: Lipemia (1000 mg/dL) at 16.0 µg/mL Vanco | -0.2% Change (Predicate: Not specified) |
| Valproic Acid Method (Predicate: Abbott TDx Valproic Acid method) | |
| Analytical Range | 0.3-150 µg/mL (Predicate: Not explicitly stated, but implied similar operating range) |
| Precision (Total) @ 37.5 µg/mL | 3.8% @ 20.3 µg/mL (Predicate: 3.4%) |
| Precision (Total) @ 75 µg/mL | 2.4% @ 60.2 µg/mL (Predicate: 3.4%) |
| Precision (Total) @ 125 µg/mL | 2.8% @ 108.5 µg/mL (Predicate: 3.7%) |
| Correlation (y=1.11x + 0.27, r=0.993, Sux=3.79 µg/dL) | Matched to Predicate |
| Interfering Substances: Bilirubin unconjugated (25 mg/dL) at 82.5 µg/mL VA | +6% Change (Predicate: Not specified) |
| Interfering Substances: Bilirubin conjugated (25 mg/dL) at 78.1 µg/mL VA | +1% Change (Predicate: Not specified) |
| Interfering Substances: Hemoglobin (1000 mg/dL) at 80.2 µg/mL VA | +4% Change (Predicate: Not specified) |
| Interfering Substances: Lipemia (500 mg/dL) at 80.8 µg/mL VA | +3% Change (Predicate: Not specified) |
2. Sample Sizes Used for the Test Set and Data Provenance:
- C3 Method: n = 101 samples for correlation. Data provenance is not specified (e.g., country of origin, retrospective or prospective).
- C4 Method: n = 94 samples for correlation. Data provenance is not specified.
- IgA Method: n = 97 samples for correlation. Data provenance is not specified.
- IgG Method: n = 97 samples for correlation. Data provenance is not specified.
- IgM Method: n = 89 samples for correlation. Data provenance is not specified.
- TRF Method: n = 106 samples for correlation. Data provenance is not specified.
- Vancomycin Method: n = 55 samples for correlation. Data provenance is not specified.
- Valproic Acid Method: n = 55 samples for correlation. Data provenance is not specified.
For precision and interfering substances studies, specific sample numbers are not given, but they are implied to be sufficient for the reported percentages. The studies appear to be clinical validation studies performed by the manufacturer. These are typically prospective studies using human serum samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The concept of "experts" and "ground truth" as typically applied to image-based diagnostic AI algorithms (e.g., radiologists) is not directly applicable here. For these in vitro diagnostic (IVD) devices, the "ground truth" is established by:
- Predicate Device Measurements: The performance of the predicate device (BNA Complement C3 method, etc.) serves as the reference standard for correlation studies. The predicate devices themselves would have undergone rigorous validation.
- Reference Methods/Laboratory Standards: For precision, linearity, and interference studies, the "ground truth" for the concentration levels would be established using validated internal laboratory methods, certified reference materials, or gravimetric/volumetric standards, not expert readers.
Therefore, no information on "number of experts" or their "qualifications" is provided, as it's not relevant to this type of device comparison.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are primarily used in studies where human interpretation of data (like medical images) is involved and discrepancies need to be resolved. For quantitative IVD devices measuring biomolecules, agreement is by quantitative comparison to a reference method or predicate device, not by expert consensus on interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. MRMC studies are specific to evaluating the impact of an AI system on human reader performance, particularly in diagnostic imaging. This document describes the performance of an automated laboratory assay, not an AI algorithm assisting human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies reported are essentially "standalone" performance studies for the Bayer ADVIA IMS systems. These are automated systems performing quantitative measurements. The performance metrics (precision, correlation, analytical range, interference) evaluate the device's inherent analytical capabilities, independent of human interaction during the measurement process, aside from loading samples and reagents.
7. The Type of Ground Truth Used:
The ground truth used for these studies is primarily:
- Predicate Device Measurements: For correlation studies, the measurements obtained from the predicate devices (e.g., Dade Behring BNA methods, Bayer Immuno 1, Abbott TDx) are considered the reference against which the ADVIA IMS device is compared. This demonstrates "substantial equivalence."
- Known Concentrations/Spiked Samples: For precision, analytical range, and interfering substance studies, the "ground truth" is established by using samples with known concentrations (e.g., control materials, diluted samples, samples spiked with interfering substances).
8. The Sample Size for the Training Set:
The concept of a "training set" applies to machine learning or AI models that learn from data. These documents describe the performance validation of traditional IVD assays. Therefore, there is no "training set" in the context of an AI algorithm, and no sample size is applicable or reported for such a purpose. The data presented are for validation/testing of the assay.
9. How the Ground Truth for the Training Set Was Established:
As there is no "training set" described for a machine learning model, this question is not applicable. The methods described are for chemical assays, not AI algorithms requiring training data.
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ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
The Baver ADVIA IMS Albumin assay is an in vitro diagnostic device intended to measure Albumin in human serum or plasma. Measurements of albumin are used in the diagnosis, monitoring and treatment of a variety of diseases involving the liver and kidney.
The Bayer ADVIA IMS Total Bilirubin assay is an in vitro diagnostic device intended to measure bilirubin in human serum or plasma. Measurements of direct or total bilirubin, organic compounds formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis, monitoring and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder disorders.
The Bayer ADVIA IMS Carbon Dioxide (CO2) assay is an in vitro diagnostic method intended to measure CO2 in human serum. Measurements of CO2 are used as an aid in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
The Bayer ADVIA IMS Digoxin assay is an in vitro diagnostic device intended to measure Digoxin, a cardioactive drug, in human serum. Measurements of Digoxin are used as an aid in the diagnosis of Digoxin overdose and in the monitoring therapeutic levels of Digoxin to ensure appropriate therapy.
The Baver ADVIA IMS HDL Cholesterol assay is an in vitro diagnostic device intended to measure HDL Cholesterol (a lipoprotein) in human serum and plasma. Such measurements are used as an aid in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
The Bayer ADVIA IMS Inorganic Phosphorus assay is an in vitro diagnostic device intended to measure phosphorus in human serum, plasma or urine. Measurements of inorganic phosphorus are used in the diagnosis, monitoring and treatment of a variety of diseases involving the parathyroid gland and kidney, and vitamin D imbalance.
The Bayer ADVIA IMS Ion Selective Electrode assays for Sodium,Potassium,and Chloride are in vitro diagnostic devices intended to measure these analytes in human serum or plasma. Measurements of sodium are used as an aid in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension. Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium are used as an aid in the diagnosis and treatment of renal tubular disease, hyperaldosteronism, metabolic alkolosis, adrenocortical disease and diabetic ketoacidosis. Measurements of chloride are used as an aid in the diagnosis and treatment of acid-base and water imbalance. It is especially important to measure chloride during the correction of hypokalemic alkalosis and also during severe, prolonged vomiting which lowers serum chloride levels.
Not Found
This response describes the acceptance criteria and study details for several in vitro diagnostic methods on the Bayer ADVIA IMS system, based on the provided text. Since the original text combines multiple device summaries, I've organized the information by individual assay.
1. Albumin method for ADVIA® IMS
1. Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance / Clinical Relevance) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Imprecision | Similar to or better than predicate (Technicon CHEM 1 Albumin) | |
| Level 2.1 g/dL | (No explicit predicate data provided for this level) | Total CV(%): 1.9 |
| Level 3.4 g/dL | (No explicit predicate data provided for this level) | Total CV(%): 1.6 |
| Level 4.9 g/dL | (No explicit predicate data provided for this level) | Total CV(%): 1.5 |
| Correlation | High correlation (r ≥ 0.975 typically) and low Syx compared to predicate. | |
| Serum | - | N=53, Y=1.01X+0.55, Syx=0.13 g/dL, r=0.990 |
| Plasma(y), Serum(x) | - | N=59, Y=0.96X+0.12, Syx=0.06 g/dL, r=0.978 |
| Analytical Range | Comparable to predicate and clinically relevant | Serum/Plasma: 1 to 6 g/dL |
| Interference | Minimal effect from common interfering substances | U. Bilirubin (25mg/dL): -4.8% @ 4.2 g/dL |
| Hemoglobin (1000mg/dL): +5.7% @ 3.5 g/dL | ||
| Lipids (1000mg/dL): -2.9% @ 3.5 g/dL |
2. Sample size and data provenance (test set):
- Serum Correlation: N=53. Data provenance is not specified (retrospective or prospective, country of origin).
- Plasma/Serum Correlation: N=59. Data provenance is not specified.
- Imprecision: Not explicitly stated how many samples per level, but standard practice involves running multiple replicates over several days. Data provenance not specified.
- Interfering Substances: For each substance, 1 sample was tested at a specific albumin concentration. Data provenance not specified.
3. Number of experts and qualifications (ground truth for test set):
Not applicable. This is an in-vitro diagnostic device for measuring a chemical analyte. The ground truth would be established by the reference method (predicate device or other accepted laboratory method).
4. Adjudication method (test set):
Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study:
Not applicable. This is an in-vitro diagnostic device without human-in-the-loop performance.
6. Standalone performance (algorithm only without human-in-the-loop):
Yes, the provided data represents the standalone performance of the ADVIA IMS Albumin method directly compared to the predicate device (Technicon CHEM 1 Albumin) and its own performance characteristics.
7. Type of ground truth used:
For correlation, the predicate device (Technicon CHEM 1 Albumin) served as the comparison system, implying its measurements were considered the "ground truth" or reference. For imprecision, the measured values are compared against themselves over multiple runs.
8. Sample size for training set:
Not applicable. For this type of in-vitro diagnostic device, there isn't a "training set" in the machine learning sense. Performance is validated through analytical studies (imprecision, correlation, interference).
9. How ground truth for training set was established:
Not applicable.
2. T.Bilirubin method for ADVIA® IMS
1. Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance / Clinical Relevance) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Imprecision | Similar to or better than predicate (Technicon CHEM 1 T.Bilirubin) | |
| Level 1.1 mg/dL | Predicate: 9.1% Total CV | Total CV(%): 7.0 |
| Level 4.5/5.0 mg/dL | Predicate: 4.8% Total CV | Total CV(%): 5.1 |
| Level 17.0/20.0 mg/dL | Predicate: 2.6% Total CV | Total CV(%): 2.4 |
| Correlation | High correlation (r ≥ 0.975 typically) and low Syx compared to predicate. | |
| Serum | - | N=58, Y=1.08X-0.11, Syx=0.26 mg/dL, r=0.998 |
| Plasma(y), Serum(x) | - | N=57, Y=1.01X-0.01, Syx=0.02 mg/dL, r=0.994 |
| Analytical Range | Comparable to predicate and clinically relevant | Serum/Plasma: 0 to 45 mg/dL |
| Interference | Minimal effect from common interfering substances | Hemoglobin (500mg/dL): +1% @ 6.9 mg/dL |
| Lipids (500mg/dL): -34% @ 6.7 mg/dL |
2. Sample size and data provenance (test set):
- Serum Correlation: N=58. Data provenance is not specified (retrospective or prospective, country of origin).
- Plasma/Serum Correlation: N=57. Data provenance is not specified.
- Imprecision: Not explicitly stated how many samples per level, but standard practice involves running multiple replicates over several days. Data provenance not specified.
- Interfering Substances: For each substance, 1 sample was tested at a specific T.Bilirubin concentration. Data provenance not specified.
3. Number of experts and qualifications (ground truth for test set):
Not applicable. This is an in-vitro diagnostic device for measuring a chemical analyte. The ground truth would be established by the reference method (predicate device or other accepted laboratory method).
4. Adjudication method (test set):
Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study:
Not applicable.
6. Standalone performance (algorithm only without human-in-the-loop):
Yes, the provided data represents the standalone performance of the ADVIA IMS T.Bilirubin method directly compared to the predicate device (Technicon CHEM 1 T.Bilirubin) and its own performance characteristics.
7. Type of ground truth used:
For correlation, the predicate device (Technicon CHEM 1 T.Bilirubin) served as the comparison system, implying its measurements were considered the "ground truth" or reference. For imprecision, the measured values are compared against themselves over multiple runs.
8. Sample size for training set:
Not applicable.
9. How ground truth for training set was established:
Not applicable.
3. CO2 Method for the Bayer ADVIA Integrated Modular System (IMS)
1. Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance / Clinical Relevance) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Analytical Range | Comparable to predicate and clinically relevant | 10 to 40 mEq/L |
| Precision (Total) | Similar to or better than predicate (Technicon CHEM 1 CO2) | |
| @ 11.98 mEq/L | Predicate: 4.5% @ 14 mEq/L | 5.3% |
| @ 19.10 mEq/L | Predicate: 3.8% @ 22 mEq/L | 4.3% |
| @ 28.39 mEq/L | Predicate: 3.3% @ 28 mEq/L | 3.0% |
| Correlation | High correlation (r ≥ 0.975 typically) and low Syx compared to predicate. | N=106 (53 pairs), Y=0.99X+0.41 mEq/L, r=0.993, Syx=0.999 mEq/L |
| Interference | Minimal effect from common interfering substances (e.g., |
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(56 days)
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
The Bayer ADVIA IMS Amylase assay is an in vitro diagnostic device intended to measure amylase activity in human serum, plasma or urine. Such measurements are used as an aid primarily in the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
The Bayer ADVIA IMS Cortisol assay is an in vitro diagnostic device intended to quantitatively measure cortisol in human serum. Measurements of cortisol are used as an aid in the diagnosis and treatment of disorders of the adrenal gland.
The Bayer ADVIA IMS Iron assay is an in vitro diagnostic device intended to measure iron in human serum of plasma. Measurements of iron are used as an aid in the diagnosis, monitoring and treatment of a variety of diseases including iron deficiency anemias, hemochromatosis, hemosiderosis from excessive iron intake, and hemolytic anemias.
The Baver ADVIA IMS Thyroxine assay is an in vitro diagnostic device intended to measure thyroxine (T4), both protein bound and free, in human serum and plasma. Measurements of T4 are used as an aid in the diagnosis and treatment of thyroid diseases.
The Baver ADVIA IMS Free Thyroxine (FT4) assay is an in vitro diagnostic device intended to quantitatively measure free thyroxine in human serum. Measurements of free thyroxine in conjunction with other thyroid tests and clinical indicators are used as an aid in the diagnostic discrimination and assessment of thyroid diseases.
The Bayer ADVIA IMS Triiodothyronine (T3) assay is an in vitro diagnostic device intended to quantitatively measure triiodothyronine (T3) in human serum. Measurements of triiodothyronine, in conjunction with other thyroid tests and clinical indicators, are used as an aid in the diagnostic discrimination and assessment of thyroid diseases.
The Bayer ADVIA IMS Free Triiodothyronine (FT3) assay is an in vitro diagnostic device intended to quantitatively measure free triiodothyronine in human serum. Measurements of free triodothyronine, in conjunction with other first-line thyroid tests such as Thyroid Stimulating Hormone (TSH) and Free Thyroxine (Free T4), as well as other clinical indicators, are used as an aid in the diagnostic discrimination and assessment of thyroid diseases.
The Bayer ADVIA IMS T Uptake (TUP) assay is an in vitro diagnostic device intended to quantitatively measure the total amount of available binding sites for thyroid hormone on the thyroxine-binding proteins, globulin, pre-albumin, and albumin in human serum. Measurements of T Uptake, in conjunction with other thyroid tests and clinical indicators, are used as an aid in the diagnostic discrimination and assessment of thyroid diseases.
The Bayer ADVIA IMS Urea Nitrogen (BUN) method is an in vitro diagnostic device intended to measure urea nitrogen in human serum, plasma and urine. Such measurements are used as an aid in the diagnosis and treatment of certain renal and metabolic diseases.
Not Found
The provided document describes the performance characteristics of various assays on the Bayer ADVIA IMS Systems, not an AI device. Therefore, several requested fields, such as "Multi-reader multi-case (MRMC) comparative effectiveness study," "Effect size of human readers improvement," "Standalone algorithm performance," "Number of experts for ground truth," "Qualifications of experts," "Adjudication method," and "Sample size for training set," are not applicable as they pertain to AI/ML device studies.
The document presents information comparing the performance of the ADVIA IMS assays to predicate devices. The acceptance criteria for these devices are implicitly demonstrated by showing comparable or superior performance to the legally marketed predicate devices, which is the basis for 510(k) clearance for in-vitro diagnostic devices, establishing substantial equivalence.
Acceptance Criteria and Device Performance (for each assay)
The acceptance criteria are generally demonstrated by showing strong correlation, comparable precision, and acceptable interference profiles relative to the predicate device.
1. Amylase (AMY) Method for the ADVIA IMS Systems (Section 0, 1)
| Acceptance Criteria Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Analytical Range | 10 to 3400 U/L (RA-XT) | 0 to 1500 U/L |
| Precision (Total) | Serum: 51 U/L: 2.2% CV; 179 U/L: 1.0% CV; 373 U/L: 0.6% CV (RA-XT) | Serum: 56 U/L: 2.5% CV; 113 U/L: 2.1% CV; 430 U/L: 1.5% CV |
| Urine: 57 U/L: 3.4% CV; 172 U/L: 1.3% CV; 510 U/L: 1.3% CV (RA-XT) | Urine: 50 U/L: 1.3% CV; 218 U/L: 1.1% CV; 493 U/L: 1.6% CV | |
| Correlation (Serum) | Strong correlation to RA-XT | y = 1.01x - 5.7 (r = 0.999, Sy.x = 11.9) |
| Correlation (Plasma equiv.) | Strong correlation to serum (reference method) | y = 1.00x - 0.2 (r = 0.999, Sy.x = 1.0) |
| Correlation (Urine) | Strong correlation to RA-XT | y = 1.01x - 5.7 (Note: discrepancy - original table shows range, not equation. This might be a typo in the original document, as the serum equation is repeated but with urine range criteria) |
| Interference (Serum) | Minimal effect (e.g., within a few % change) | Hemoglobin: +2%; Bilirubin (conj): -4%; Bilirubin (unconj): -2%; Lipemia: +3% |
| Interference (Urine) | Minimal effect (e.g., within a few % change) | Ascorbic Acid: 1%; Acetaminophen: -1%; Salicylate: -2% |
2. Cortisol Method for Bayer ADVIA® IMS™ (Section 2)
| Acceptance Criteria Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA Cortisol) |
|---|---|---|
| Minimum Detectable Conc. | 0.2 µg/dL (Immuno 1) | 0.1 µg/dL |
| Precision (Total CV%) | 3.2 µg/dL: 7.9%; 20.1 µg/dL: 4.5%; 33.3 µg/dL: 4.7% (Immuno 1) | 4.4 µg/dL: 6.0%; 17.3 µg/dL: 5.0%; 37.5 µg/dL: 3.8% |
| Correlation | Strong correlation to Immuno 1 | y = 1.013 x - 0.142 (r = 0.996, Syx = 0.961 µg/dL) |
| Interference | Minimal effect (e.g., within a few % change) | Hemoglobin: -4.8%; Lipids: -4.5%; Bilirubin: -1.9%; Urea Nitrogen: -4.4% |
3. Iron Method for the Bayer ADVIA Integrated Modular System (IMS) (Section 3, 4)
| Acceptance Criteria Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA IMS Iron) |
|---|---|---|
| Analytical Range | 0 to 1200 ug/dL (CHEM 1) | 0 to 800 ug/dL |
| Precision (Total) | 96 ug/dL: 1.9%; 211 ug/dL: 1.3%; 383 ug/dL: 1.2% (CHEM 1) | 50.7 ug/dL: 2.8%; 230.1 ug/dL: 1.1%; 438.3 ug/dL: 0.7% |
| Correlation | Strong correlation to CHEM 1 | Y=0.93X+10.8 ug/dL (r=0.998, Sy.x=9.75 ug/dL) |
| Plasma/Serum Equivalence | Strong correlation to serum (reference method) | Y=0.98X+0.46 ug/dL (r=0.99, Sy.x=3.12 ug/dL) |
| Interference | Minimal effect (e.g., within a few % change) | Bilirubin (unconj): 7.0%; Bilirubin (conj): -1.0%; Hemoglobin: 44.0%; Lipemia: -20.0% |
4. T4 Method for the Bayer ADVIA® IMS Systems (Section 5, 6)
| Acceptance Criteria Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA IMS T4) |
|---|---|---|
| Minimum Det. Conc. | 0.4 µg/dL (Immuno 1) | 0.25 µg/dL |
| Precision (Total) | 4.7 µg/dL: 3.6%; 8.2 µg/dL: 2.6%; 15.7 µg/dL: 2.5% (Immuno 1) | 3.5µg/dL: 6.0%; 7.9 µg/dL: 5.1%; 14.9 µg/dL: 4.7% |
| Correlation (SERUM) | Strong correlation to Immuno 1 | y = 1.06 x +0.11 (r = 0.994, Syx = 0.65 µg/dL) |
| Correlation (PLASMA) | Strong correlation to serum (reference method) | y = 0.98X + 0.06 (r = 0.977, Syx = 0.36) |
| Interference | Minimal effect (e.g., within a few % change) | Bilirubin (unconj): 0%; Bilirubin (conj): -2%; Hemoglobin: -3%; Lipemia: +3% |
5. Free T4 Assay for Bayer ADVIA® Integrated Modular System (Section 7)
| Acceptance Criteria Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA FREE T4 Assay) |
|---|---|---|
| Minimum Detectable Conc. | 0.10 ng/dL (Immuno 1) | 0.05 ng/dL |
| Precision (Total CV) | 0.94 ng/dL: 4.9%; 1.76 ng/dL: 3.5%; 4.68 ng/dL: 2.2% (Immuno 1) | 0.85 ng/dL: 4.5%; 1.46 ng/dL: 4.8%; 3.04 ng/dL: 3.0% |
| Correlation | Strong correlation to Immuno 1 | y = 0.998 x + 0.2179 (r = 0.9928, Syx = 0.1368 ng/dL) |
| Interference | Minimal effect (e.g., within a few % change) | Hemoglobin: 3.8%; Lipids: 2.2%; Bilirubin: 0.6%; Urea Nitrogen: 1.1% |
6. Total T3 Assay for Bayer ADVIA® Integrated Modular System (Section 8)
| Acceptance Criteria Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA T3 Assay) |
|---|---|---|
| Minimum Detectable Conc. | 0.06 ng/mL (Immuno 1) | 0.13 ng/mL |
| Precision (Total CV) | 0.46 ng/mL: 13.3%; 1.34 ng/mL: 6.0%; 3.43 ng/mL: 3.9% (Immuno 1) | 0.67 ng/mL: 10.3%; 1.74 ng/mL: 4.9%; 2.89 ng/mL: 3.6% |
| Correlation | Strong correlation to Immuno 1 | y = 1.014x + 0.1368 (r = 0.996) |
| Interference | Minimal effect (e.g., within a few % change) | Hemoglobin: 3.7%; Lipids: 5.5%; Bilirubin: 3.0%; Urea Nitrogen: (data partially illegible but likely similar minimal effect) |
7. Free T3 Assay for Bayer ADVIA® Integrated Modular System (Section 9)
| Acceptance Criteria Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA Free T3 Assay) |
|---|---|---|
| Minimum Detectable Conc. | 0.3 pg/mL (Immuno 1) | 0.4 pg/mL |
| Precision (Total CV) | 1.8 pg/mL: 8.5%; 5.4 pg/mL: 3.8%; 10.8 pg/mL: 2.9% (Immuno 1) | 2.0 pg/mL: 10.0%; 4.88 pg/mL: 5.0%; 9.35 pg/mL: 4.1% |
| Correlation | Strong correlation to Immuno 1 | y = 0.97x + 0.41 (r = 0.998, Syx = 0.427 pg/mL) |
| Interference | Minimal effect (e.g., within a few % change) | Hemoglobin: 6.4% (value partially illegible/corrupted); Lipids: 9.4% (value partially illegible/corrupted); Bilirubin: -3.4%; Urea Nitrogen: 2.1% |
8. T-Uptake Assay for Bayer ADVIA® Integrated Modular System (Section 10)
| Acceptance Criteria Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA T-Uptake Assay) |
|---|---|---|
| Precision (Total CV) | 0.71: 2.8%; 1.03: 2.6%; 1.41: 2.4% (Immuno 1) | 0.96: 3.2%; 0.89: 2.6%; 1.14: 2.3% |
| Correlation | Strong correlation to Immuno 1 | y = 0.96x + 0.0003 (r = 0.987) |
| Interference | Minimal effect (e.g., within a few % change) | Hemoglobin: 0.88%; Lipids: 0.90%; Bilirubin: 1.74%; Urea Nitrogen: 0.91% |
9. Urea Nitrogen method for ADVIA® 400 (Section 11, 12)
| Acceptance Criteria Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA 400 Urea Nitrogen) |
|---|---|---|
| Analytical Range | (Not explicitly stated for CHEM 1, assumed to cover relevant clinical range) | Serum/Plasma: 0 to 150 mg/dL; Urine: 2 to 1030 mg/dL |
| Imprecision (SERUM) | 21 mg/dL: 3%; 54 mg/dL: 3%; 97 mg/dL: 3% (CHEM 1) | 7.3 mg/dL: 4.3%; 17 mg/dL: 2.5%; 52 mg/dL: 1.6% |
| Imprecision (URINE) | 478 mg/dL: 2.6%; 648 mg/dL: 2.5% (CHEM 1) | 69 mg/dL: 3.9%; 212 mg/dL: 2.1%; 404 mg/dL: 2.0% |
| Correlation (Serum) | Strong correlation to CHEM 1 | Y=1.03X-0.6 (r=0.997, Syx=2.8 mg/dL) |
| Correlation (Plasma equiv.) | Strong correlation to serum (reference method) | Y=0.96X+0.6 (r=0.975, Syx=1.1) |
| Correlation (Urine) | Strong correlation to CHEM 1 | Y=1.08X-8.9 (r=0.997, Syx=22.5) |
| Interference | Minimal effect (e.g., within a few % change) | Bilirubin: -4.0%; Hemoglobin: +4.4%; Lipids: +23.0%; Ascorbic Acid: +3.2%; Salicylate: -2.4%; Glucose: +9.5%; Acetominophen: +4.5% |
Study Details
This document describes a series of performance studies for multiple in-vitro diagnostic assays on the Bayer ADVIA IMS Systems. The studies aim to demonstrate "substantial equivalence" to predicate devices, which is a regulatory pathway for marketing these devices.
2. Sample size used for the test set and the data provenance:
- AMY Method:
- Serum Correlation: n = 72
- Plasma Qualification: n = 60
- Urine Correlation: n = 72
- Provenance: Not explicitly stated, but typically these studies are conducted with clinical samples from various sources (e.g., hospitals, labs) within the country where the manufacturer is seeking clearance or where R&D is conducted. It's retrospective in the sense that samples are collected and then analyzed.
- Cortisol Method:
- Correlation: n = 57
- Provenance: Not explicitly stated.
- Iron Method:
- Correlation: n = 65
- Plasma/Serum Equivalence: n = 56
- Provenance: Not explicitly stated.
- T4 Method:
- Serum Correlation: n = 72
- Plasma Correlation: n = 24
- Provenance: Not explicitly stated.
- Free T4 Assay:
- Correlation: n = 50
- Provenance: Not explicitly stated.
- Total T3 Assay:
- Correlation: n = 50
- Provenance: Not explicitly stated.
- Free T3 Assay:
- Correlation: n = 56
- Provenance: Not explicitly stated.
- T-Uptake Assay:
- Correlation: n = 51
- Provenance: Not explicitly stated.
- Urea Nitrogen Method:
- Serum Correlation: n = 50
- Plasma (y), Serum (x) Correlation: n = 58
- Urine Correlation: n = 53
- Provenance: Not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. These are in-vitro diagnostic tests for quantitative measurement of analytes. "Ground truth" is established by laboratory reference methods or predicate devices, not human expert interpretation.
4. Adjudication method for the test set:
Not applicable. Ground truth for quantitative chemical assays is determined by analytical methods, not human adjudication.
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 document is for in-vitro diagnostic assays, not AI/ML devices requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. These are automated laboratory assays, and their performance is inherently "standalone" in a laboratory setting, meaning the instrument and reagents produce a result without human interpretation of raw data points, beyond quality control and review of final numerical results.
7. The type of ground truth used:
For each assay, the "ground truth" (or reference method) for analytical performance comparison is the predicate device (e.g., Bayer RA-XT Amylase method, Immuno 1 Cortisol assay, Technicon CHEM 1 Iron-II method, etc.) or a well-established reference method (e.g., serum for plasma equivalence studies). The performance is assessed by comparison (correlation, regression) against results obtained from these predicate devices on the same samples.
8. The sample size for the training set:
Not applicable. These are traditional IVD assays, not machine learning models that require a separate training set. The "development" of the assay involves optimizing reagents and instrument parameters, not training on a dataset in the AI sense.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set in the AI/ML sense, no ground truth was established for it.
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BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
The Bayer ADVIA IMS alkaline phosphatase (ALP) assay is an in-vitro diagnostic device intended to measure ALP in human serum or plasma. Such measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This diagnostic method is not intended for use on any other diagnostic system.
This in vitro method is intended to quantitatively measure calcium in human serum and plasma on the Bayer ADVIA IMS. Measurements of calcium are used in the diagnosis, monitoring and treatment of a variety of diseases including parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
The Bayer ADVIA IMS Glucose assay is an in vitro diagnostic device intended to measure glucose in human serum or plasma. Such measurements are used in the diagnosis, monitoring and treatment of carbohydrate metabolism disorders, including diabetes mellitus and neonatal hypoglycemia. This diagnostic method is not intended for use on any other diagnostic system.
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 diagnostic method is not intended for use on any other diagnostic system.
This in viro method is intended to quantitatively measure hCG, human chorionic gonadotropin, in human serum using ADVIA hCG Assay on a Bayer ADVIA® Integrated Modular System. Measurements of hCG are used in the detection of pregnancy. This diagnostic method is not intended for use on any other diagnostic system.
This in viro method is intended to quantitatively measure TSH, Thyroid Stimulating Hormone, in human serum using ADVIA 3d Generation TSH Assay on a Bayer ADVIA® Integrated Modular System. This assay allows the determination of TSH with 3d generation sensitivity of less than 20% total coefficient of variation (CV) at 0.02 µIU/mL, as defined by the American Thyroid Association. Measurements thyroid stimulating hormone are used in the diagnosis of thyroid or pituitary disorders. This diagnostic method is not intended for use on any other diagnostic system.
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Here's an analysis of the provided text, outlining the acceptance criteria and study details for each assay method on the Bayer ADVIA IMS System. Please note that the document primarily focuses on demonstrating substantial equivalence to a predicate device, which means the "acceptance criteria" are largely implied by the performance of the predicate device and direct comparison studies. There are no explicit, pre-defined acceptance criteria listed as pass/fail thresholds in the provided text, but rather observed performance values used for comparison.
General Observations:
- Device Type: This document describes in-vitro diagnostic devices (assays) for measuring various analytes in human serum or plasma.
- Study Type: The studies described are primarily method comparison studies (correlation, regression) and precision studies, along with interference studies. These are standard for demonstrating substantial equivalence for IVDs.
- Ground Truth: For these types of quantitative assays, the "ground truth" is generally established by the reference method (the predicate device) or by highly controlled laboratory measurements. There isn't an "expert consensus" or "pathology" in the typical sense for these quantitative measurements.
- Human-in-the-loop/MRMC: These concepts are not applicable to the performance evaluation of a quantitative, automated in-vitro diagnostic assay. The device performs the measurement; it's not an AI assisting a human reader in interpretation.
- Data Provenance: The data is implicitly retrospective as it compares the new device's performance to an already cleared predicate. No specific country of origin is mentioned, but Bayer Corporation has its headquarters in the US.
- Ground Truth for Training Set: Since these are largely traditional chemical/immunoassay methods and not AI/ML algorithms in the modern sense (which require a distinct training phase), the concept of a "training set" for an algorithm and how its ground truth was established is not directly applicable. The "development" of such assays involves optimizing reagents and protocols.
1. Alkaline Phosphatase (ALP) Method
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA IMS) |
|---|---|
| Analytical Range: 0 to 2250 U/L (Chem 1) | 0 to 2800 U/L |
| Precision (Total %CV): | |
| - At ~65 U/L: 3.8% (Chem 1) | - At 74 U/L: 3.6% |
| - At ~263 U/L: 3.3% (Chem 1) | - At 160 U/L: 2.9% |
| - At ~547 U/L: 3.2% (Chem 1) | - At 420 U/L: 2.1% |
| Regression (vs. Chem 1): (Implied close correlation) | y = 0.96x + 2.0 (r = 0.999, Sy.x = 11.2) |
| Plasma Qualification (vs. Serum): (Implied close correlation) | y = 1.06x - 0.9 (r = 0.999, Sy.x = 0.93) |
| Interference (% Change): (Implied acceptable levels) | |
| - Hemoglobin (500mg/dL): 9% | |
| - Bilirubin (conjugated, 20mg/dL): 8% | |
| - Bilirubin (unconjugated, 25mg/dL): 1% | |
| - Lipemia (Triglycerides, 1000mg/dL): 3% |
Study Details:
- Sample sizes for test set:
- Regression (serum comparison): n = 74
- Regression (plasma qualification): n = 59
- Interference: Not explicitly stated per interfering substance, but done at specific analyte concentrations.
- Data Provenance: Not specified, but likely samples collected from a clinical laboratory setting, retrospective for the purpose of comparison.
- Number of experts and qualifications: Not applicable. These are quantitative chemical assays, not image interpretation.
- Adjudication method: Not applicable. Direct quantitative measurements.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance: Yes, the performance data provided (analytical range, precision, interference) represents the standalone performance of the ADVIA IMS ALP method. The regression studies compare its standalone performance to another standalone device.
- Type of ground truth: The "ground truth" for the comparative studies is the measurement obtained from the predicate device (Bayer Chem 1 ALP(AMP) method). For interference studies, it is the measurement of the sample without the interfering substance ("neat concentration") or at a known baseline.
- Sample size for training set: Not applicable for this type of IVD (not an AI/ML algorithm requiring a training set).
- Ground truth for training set: Not applicable.
2. Calcium Method
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA IMS) |
|---|---|
| Analytical Range: 1 to 15 mg/dL (Chem 1) | 0 to 14.0 mg/dL |
| Precision (Total): | |
| - @ 8.4 mg/dL: 2.3% (Chem 1) | - @ 8.4 mg/dL: 1.1% |
| - @ 10.6 mg/dL: 2.5% (Chem 1) | - @ 10.4 mg/dL: 2.2% |
| - @ 13.4 mg/dL: 2.2% (Chem 1) | - @ 13.6 mg/dL: 0.9% |
| Correlation (vs. Chem 1): (Implied close correlation) | y = 0.96 - 0.8 mg/dL (n=48, r=0.996, Sy.x=0.01 mg/dL) |
| Plasma/Serum Equivalence: (Implied minimal difference) | 0.00 difference at 8.4 mg/dL, 0.75% Within-run CV for plasma vs. 0.73% for serum |
| Interference (% Effect Change): (Implied acceptable levels) | |
| - Bilirubin (unconjugated, 25mg/dL): 1.1% | |
| - Hemoglobin (1000mg/dL): 3.0% | |
| - Triglycerides (500mg/dL): 3.0% |
Study Details:
- Sample sizes for test set:
- Correlation: n = 48
- Plasma/Serum Equivalence: Not explicitly stated, but includes a specific concentration (8.4 mg/dL).
- Interference: Not explicitly stated per interfering substance, but done at specific analyte concentrations.
- Data Provenance: Not specified, likely retrospective clinical samples.
- Number of experts and qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance: Yes, performance data reflects standalone operation, with correlation against a predicate.
- Type of ground truth: Measurements from the predicate device (Technicon CHEM 1 Calcium method) for correlation. Known baseline or reference values for precision and interference.
- Sample size for training set: Not applicable.
- Ground truth for training set: Not applicable.
3. Glucose Method
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA IMS) |
|---|---|
| Analytical Range: 0 to 675 mg/dL (Chem 1) | 0 to 800 mg/dL |
| Precision (Total %CV): | |
| - At ~87 mg/dL: 2.7% (Chem 1) | - At 48 mg/dL: 3.66% |
| - At ~262 mg/dL: 2.9% (Chem 1) | - At 97 mg/dL: 3.03% |
| - At ~305 mg/dL: 2.3% (Chem 1) | - At 293 mg/dL: 1.80% |
| - At ~562 mg/dL: 1.3% (Chem 1) | |
| Regression (serum vs. Chem 1): (Implied close correlation) | y = 1.03x + 0.71 (n=58, r=0.993, Sy.x=11.4) |
| Regression (plasma qualification vs. serum): (Implied close correlation) | y = 0.97x + 4.12 (n=60, r=0.943, Sy.x=4.1) |
| Interference (% Change): (Implied acceptable levels) | |
| - Hemoglobin (1000mg/dL): 0.5% | |
| - Bilirubin (conjugated, 25mg/dL): 0.5% | |
| - Bilirubin (unconjugated, 25mg/dL): 1.3% | |
| - Lipemia (Triglycerides, 500mg/dL): 9.5% |
Study Details:
- Sample sizes for test set:
- Regression (serum comparison): n = 58
- Regression (plasma qualification): n = 60
- Interference: Not explicitly stated per interfering substance, but done at specific analyte concentrations.
- Data Provenance: Not specified, likely retrospective clinical samples.
- Number of experts and qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance: Yes, performance data reflects standalone operation, with correlation against a predicate.
- Type of ground truth: Measurements from the predicate device (Bayer Technicon Chem 1 Glucose method) for correlation. Known baseline or reference values for precision and interference.
- Sample size for training set: Not applicable.
- Ground truth for training set: Not applicable.
4. Ferritin Method
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA Ferritin) |
|---|---|
| Minimum Detectable Conc.: 0.3 ng/mL (Immuno 1) | 0.06 ng/mL |
| Precision (Total CV%): | |
| - At 21 ng/mL: 7.1% (Immuno 1) | - At 28 ng/mL: 4.1% |
| - At 148 ng/mL: 5.0% (Immuno 1) | - At 108 ng/mL: 4.8% |
| - At 344 ng/mL: 5.0% (Immuno 1) | - At 245 ng/mL: 5.0% |
| Correlation (vs. Immuno 1): (Implied close correlation) | y = 1.040x - 6.132 (n=50, r=0.993, Syx=57.50 ng/mL) |
| Interference (% Change): (Implied acceptable levels) | |
| - Hemoglobin (1000mg/dL): 0.8% | |
| - Bilirubin (27.5mg/dL): 3.5% | |
| - Urea Nitrogen (200mg/dL): 3.8% | |
| - Lipemia (Triglycerides, 1110mg/dL): 4.5% |
Study Details:
- Sample sizes for test set:
- Correlation: n = 50
- Interference: Not explicitly stated per interfering substance, but done at specific analyte concentrations.
- Data Provenance: Not specified, likely retrospective clinical samples.
- Number of experts and qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance: Yes, performance data reflects standalone operation, with correlation against a predicate.
- Type of ground truth: Measurements from the predicate device (Immuno 1 Ferritin assay) for correlation. Known baseline or reference values for precision and interference.
- Sample size for training set: Not applicable.
- Ground truth for training set: Not applicable.
5. Human Chorionic Gonadotropin (hCG) Method
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA hCG Assay) |
|---|---|
| Minimum Detectable Conc.: 0.5 mIU/mL (Immuno 1) | 0.1 mIU/mL |
| Precision (Total CV): | |
| - @ 18.3 mIU/mL: 4.0% (Immuno 1) | - @ 12.1 mIU/mL: 4.2% |
| - @ 55.7 mIU/mL: 3.7% (Immuno 1) | - @ 23.9 mIU/mL: 4.5% |
| - @ 198.1 mIU/mL: 3.7% (Immuno 1) | - @ 198.1 mIU/mL: 5.5% |
| Correlation (vs. Immuno 1): (Implied close correlation) | y = 0.99x + 1.96 (n=40, r=1.0, Syx=17.5 mIU/mL) |
| Interference (% Effect): (Implied acceptable levels) | |
| - Hemoglobin (1000 mg/dL): -2.3% | |
| - Lipids (Triglycerides, 1000 mg/dL): -8.7% | |
| - Bilirubin (25 mg/dL): -6.1% | |
| - Urea Nitrogen (200 mg/dL): -7.6% |
Study Details:
- Sample sizes for test set:
- Correlation: n = 40
- Interference: Not explicitly stated per interfering substance, but done at specific analyte concentrations.
- Data Provenance: Not specified, likely retrospective clinical samples.
- Number of experts and qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance: Yes, performance data reflects standalone operation, with correlation against a predicate.
- Type of ground truth: Measurements from the predicate device (Bayer Immuno 1 hCG Assay) for correlation. Known baseline or reference values for precision and interference.
- Sample size for training set: Not applicable.
- Ground truth for training set: Not applicable.
6. Thyroid Stimulating Hormone (TSH) Method
| Acceptance Criteria (Implied by Predicate Performance and ATA definition) | Reported Device Performance (ADVIA TSH Assay) |
|---|---|
| Minimum Detectable Conc.: 0.03 µIU/mL (Immuno 1) | 0.005 µIU/mL |
| Precision (Total CV): Less than 20% CV at 0.02 µIU/mL | 13.2% @ 0.02 µIU/mL |
| Precision (Total CV) (from Immuno 1): | |
| - @ 1.3 µIU/mL: 6.3% (Immuno 1) | - @ 0.52 µIU/mL: 2.9% |
| - @ 9.0 µIU/mL: 2.0% (Immuno 1) | - @ 4.95 µIU/mL: 2.3% |
| - @ 22.5 µIU/mL: 1.8% (Immuno 1) | - @ 31.10 µIU/mL: 2.6% |
| Correlation (vs. Immuno 1): (Implied close correlation) | y = 0.98x - 0.357 (n=50, r=0.997, Syx=1.48 µIU/mL) |
| Interference (% Effect): (Implied acceptable levels) | |
| - Hemoglobin (1000 mg/dL): 1.8% | |
| - Lipids (Triglycerides, 1000 mg/dL): -0.9% | |
| - Bilirubin (28 mg/dL): (Value missing in document) | |
| - Urea Nitrogen (200 mg/dL): -1.5% |
Study Details:
- Sample sizes for test set:
- Correlation: n = 50
- Interference: Not explicitly stated per interfering substance, but done at specific analyte concentrations.
- Data Provenance: Not specified, likely retrospective clinical samples.
- Number of experts and qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance: Yes, performance data reflects standalone operation, with correlation against a predicate.
- Type of ground truth: Measurements from the predicate device (Bayer Immuno 1 TSH Assay) for correlation. Known baseline or reference values for precision and interference. The acceptance criterion for sensitivity is also tied to the American Thyroid Association standard.
- Sample size for training set: Not applicable.
- Ground truth for training set: Not applicable.
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