(56 days)
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.
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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.
§ 862.1070 Amylase test system.
(a)
Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).(b)
Classification. Class II.