Search Results
Found 5 results
510(k) Data Aggregation
(135 days)
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 < 5.7% (for 10 mg/L) | 2.9% |
| Level 2 (31.7 mg/L) | Total CV < 5.7% (for 25 mg/L) | 2.1% |
| Level 3 (47.5 mg/L) | Total CV < 5.7% (for 60 mg/L) | 3.1% |
| Imprecision (High Sensitivity Range) | ||
| Level 1 (0.25 mg/L) | No direct predicate comparison provided | 11.2% |
| Level 2 (0.52 mg/L) | Total CV < 2.5% (for 0.5 mg/L) | 5.3% |
| Level 3 (1.21 mg/L) | Total CV < 3.8% (for 1.3 mg/L) | 2.5% |
| Correlation (Normal Range) | R-value close to 1, Syx low, slope ~1, intercept ~0 (vs BN100) | Y=0.97X - 0.04; Syx=2.41 mg/L; R=0.998 |
| Correlation (High Sensitivity Range) | R-value close to 1, Syx low, slope ~1, intercept ~0 (vs BN100) | Y=0.90X - 0.08; Syx=0.11 mg/L; R=0.997 |
| Interfering Substances (Normal Range - % Change within acceptable limits) | Bilirubin (unconjugated): < target impact | +6% (5.0 mg/L CRP, 20 mg/dL Bil) |
| Bilirubin (conjugated): < target impact | +6% (5.3 mg/L CRP, 20 mg/dL Bil) | |
| Hemoglobin: < target impact | +4% (5.4 mg/L CRP, 500 mg/dL Hemoglobin) | |
| Lipids (Triglycerides): < target impact | +2% (5.2 mg/L CRP, 1000 mg/dL Lipids) | |
| Interfering Substances (High Sensitivity Range - % Change within acceptable limits) | Bilirubin (unconjugated): < target impact | -7% (1.79 mg/L CRP, 25 mg/dL Bil) |
| Bilirubin (conjugated): < target impact | +1% (1.95 mg/L CRP, 25 mg/dL Bil) | |
| Hemoglobin: < target impact | 0% (1.94 mg/L CRP, 500 mg/dL Hemoglobin) | |
| Lipids (Triglycerides): < target impact | -6% (1.82 mg/L CRP, 500 mg/dL Lipids) |
Note: The acceptance criteria are implicitly derived from the performance shown by the predicate device (Dade/Behring BN100) and the general expectations for analytical performance in diagnostic assays (e.g., high R-values for correlation, low CVs for imprecision, minimal interference). Specific numerical acceptance thresholds were not explicitly stated as "acceptance criteria" but are demonstrated by the presented data's favorable comparison to the predicate.
2. Sample Sizes and Data Provenance
| Test Type | Sample Size (Test Set) | Data Provenance |
|---|---|---|
| Imprecision | Not explicitly stated | Implied prospective testing in a laboratory setting, likely in the US, as part of device development and validation. |
| The levels (e.g., 16.5, 31.7, 47.5 mg/L for normal range; 0.25, 0.52, 1.21 mg/L for high sensitivity) suggest prepared control materials or pooled patient samples. | ||
| Correlation | 165 (Normal Range) | Clinical serum samples. Provenance (e.g., country of origin, retrospective/prospective) is not explicitly stated, but typically these are prospective clinical samples collected for method comparison. |
| 25 (High Sensitivity) | Clinical serum samples. Provenance (e.g., country of origin, retrospective/prospective) is not explicitly stated. | |
| Interference | Not explicitly stated | Implied prospective testing using prepared samples spiked with interfering substances and CRP. Likely laboratory-based. |
3. Number of Experts and Qualifications for Ground Truth
This type of submission for an in vitro diagnostic device assessing an analyte (CRP) does not typically involve human experts establishing ground truth in the way image-based diagnostics might. The "ground truth" for the performance studies described here (imprecision, correlation, interference) is established by:
- Reference Methods: For correlation studies, the predicate device (Dade/Behring BN100) serves as the reference or comparison system against which the new device's measurements are correlated. The output of the predicate device is considered the "ground truth" for comparison.
- Known Concentrations: For imprecision and interference studies, the "ground truth" refers to the known concentrations of CRP in control materials or spiked samples.
Therefore, no external clinical experts (like radiologists) are involved in establishing ground truth for these analytical performance studies.
4. Adjudication Method for the Test Set
Not applicable. Diagnostic assays measuring an analyte like CRP do not typically employ adjudication methods for their test sets in the same way clinical trials or image-based AI studies do. The readings are quantitative measurements, and accuracy is determined by comparison to reference methods or known concentrations, not by consensus among human interpreters.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study is not relevant or typically performed for this type of in vitro diagnostic device (analyte measurement). These studies are primarily for devices that rely on human interpretation of complex medical data (e.g., images) and aim to assess the impact of AI assistance on human reader performance.
6. Standalone (Algorithm Only) Performance
Yes, the studies presented are all standalone performance evaluations of the ADVIA IMS CRP assay. The device directly measures CRP concentrations in serum samples. There is no human-in-the-loop performance component in these specific analytical validation studies, as they assess the direct output of the instrument.
7. Type of Ground Truth Used
The ground truth used for these analytical studies is primarily:
- Reference Device/Method Data: For correlation, the measurements obtained from the predicate device (Dade/Behring BN100) are used as the comparative "ground truth."
- Known Concentrations/Values: For imprecision and interference studies, the ground truth is based on the known or assigned concentrations of CRP in control materials or samples spiked with specific amounts of CRP and interfering substances.
8. Sample Size for the Training Set
Not applicable. The ADVIA IMS CRP method is an immunoassay, not a machine learning or AI-based algorithm that requires a "training set" in the conventional sense. Its performance is based on chemical and optical measurements, with calibration determining its quantitative output.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an immunoassay. The device is calibrated using materials with known CRP concentrations, and this calibration process is distinct from the machine learning concept of training data. The "ground truth" for calibration materials would be established by highly accurate reference methods or certified reference materials.
Ask a specific question about this device
(66 days)
Ask a specific question about this device
(57 days)
Ask a specific question about this device
(147 days)
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.
Not Found
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., < 10% CV) | Level 5.5 mg/dL: 3.4% CV |
| Level 5.0-5.5 mg/dL | Similar to predicate (e.g., < 4% CV) | Level 11.8 mg/dL: 3.3% CV |
| Level 8.3-11.8 mg/dL | Similar to predicate (e.g., < 4% CV) | |
| Correlation (vs. CHEM 1) | ||
| Regression Equation (Y=ADVIA 400, X=CHEM 1) | Slope close to 1, Intercept close to 0 | Y=0.98X-0.10 |
| Syx (mg/dL) | Low (indicating good fit) | 0.19 |
| r (correlation coefficient) | Close to 1 (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., < 6% CV) | Level 8.36%: 4.7% CV |
| Level 8.36-8.4% | Similar to predicate (e.g., < 5% CV) | Level 11.17%: 4.6% CV |
| Level 11.17-11.2% | Similar to predicate (e.g., < 5% CV) | |
| Correlation (vs. RA-1000) | ||
| Regression Equation (Y=ADVIA IMS, X=RA-1000) | Slope close to 1, Intercept close to 0 | Y=1.00X + 0.62 |
| Syx (%) | Low (indicating good fit) | 0.33 |
| R (correlation coefficient) | Close to 1 (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., < 8% CV) | Level ~4.5 µg/mL: 4.6% CV |
| Level ~4.5-7.00 µg/mL | Similar to predicate (e.g., < 5% CV) | Level 9.14 µg/mL: 4.9% CV |
| Level 9.14-9.50 µg/mL | Similar to predicate (e.g., < 5% CV) | |
| Correlation (vs. Immuno 1) | ||
| Regression Equation (Y=ADVIA IMS, X=Immuno 1) | Slope close to 1, Intercept close to 0 | Y=1.09X - 0.29 |
| Syx (µg/mL) | Low (indicating good fit) | 0.51 |
| R (correlation coefficient) | Close to 1 (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., < 4.1% CV) | Level 2.32 mg/dL: 1.7% CV |
| Level 2.32-2.8 mg/dL | Similar to predicate (e.g., < 2.5% CV) | Level 5.29 mg/dL: 1.8% CV |
| Level 3.6-5.29 mg/dL | Similar to predicate (e.g., < 2.3% CV) | |
| Imprecision (Urine CV%) | Level 1.00 mg/dL: 8.6% CV | |
| Level 1.00-1.1 mg/dL | Similar to predicate (e.g., < 12.6% CV) | Level 6.50 mg/dL: 3.7% CV |
| Level 6.50-6.5 mg/dL | Similar to predicate (e.g., < 2.9% CV) | Level 14.24 mg/dL: 2.1% CV |
| Level 14.24-14.2 mg/dL | Similar to predicate (e.g., < 1.4% CV) | |
| Correlation (Serum vs. CHEM 1) | ||
| Regression Equation (Y=ADVIA IMS, X=CHEM 1) | Slope close to 1, Intercept close to 0 | Y=0.97X+0.06 |
| Syx (mg/dL) | Low | 0.16 |
| R (correlation coefficient) | Close to 1 | 0.998 |
| Sample Range | Appropriate for clinical use | 0.2 - 8.05 mg/dL |
| Correlation (Urine vs. CHEM 1) | ||
| Regression Equation (Y=ADVIA IMS, X=CHEM 1) | Slope close to 1, Intercept close to 0 | Y=1.02X-0.24 |
| Syx (mg/dL) | Low | 0.34 |
| R (correlation coefficient) | Close to 1 | 0.998 |
| Sample Range | Appropriate for clinical use | 1.4 - 25.0 mg/dL |
| Plasma vs. Serum Comparison | Minimal difference | Difference: 0% Sample Range: 1.63 - 2.3 mg/dL |
| Interference | Minimal clinical impact | Serum: Bilirubin (unconj. 25 mg/dL): -1%; Bilirubin (conj. 25 mg/dL): 0%; Hemoglobin (1000 mg/dL): +8%; Lipids (Trig. 500 mg/dL): -1%; Calcium (20 mg/dL): -3% Urine: Ascorbate (200 mg/dL): +2%; Salicylate (500 mg/dL): +2%; Acetaminophen (50 mg/dL): -7% |
| Analytical Range | Clinically relevant | Serum/Plasma: 0 to 8.0 mg/dL Urine: 0 to 25 mg/dL |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Sizes:
- Imprecision (CV%): Not explicitly stated.
- Correlation (Serum vs. CHEM 1): N=44
- Correlation (Urine vs. CHEM 1): N=48
- Plasma vs. Serum Comparison: N=60
- Interfering Substances: Not explicitly stated.
- Data Provenance: Retrospective, country of origin not explicitly stated (implied USA).
7. The type of ground truth used
- Imprecision: Measured value from the ADVIA IMS system itself.
- Correlation: The comparison system (Technicon CHEM 1) is used as the reference/ground truth.
- Plasma vs. Serum Comparison: Paired samples analyzed on the ADVIA IMS.
- Interfering Substances: The true concentration of Magnesium in the sample prior to adding the interferent.
- Analytical Range: Established using materials with known Magnesium concentrations.
5. Theophylline 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 | 0.47 µg/mL |
| Imprecision (CV%) | Similar to predicate | Level 9.37 µg/mL: 3.4% CV |
| Level 19.59 µg/mL: 3.0% CV | ||
| Level 29.17 µg/mL: 4.1% CV | ||
| Correlation (vs. RA-1000) | ||
| Regression Equation (Y=ADVIA IMS, X=RA-1000) | Slope close to 1, Intercept close to 0 | Y=0.98X - 0.13 |
| Syx (µg/mL) | Low (indicating good fit) | 1.37 |
| R (correlation coefficient) | Close to 1 (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., < 4.3% CV) | Level 3.71 µg/mL: 2.9% CV |
| Level 3.71-4.42 µg/mL | Similar to predicate (e.g., < 2.9% CV) | Level 7.86 µg/mL: 3.3% CV |
| Level 7.86-8.29 µg/mL | Similar to predicate (e.g., < 3.3% CV) | |
| Correlation (vs. Immuno 1) | ||
| Regression Equation (Y=ADVIA IMS, X=Immuno 1) | Slope close to 1, Intercept close to 0 | Y=0.99X - 0.05 |
| Syx (µg/mL) | Low (indicating good fit) | 0.22 |
| R (correlation coefficient) | Close to 1 (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., < 6.3% CV) | Level 6.84 mg/dL: 3.2% CV |
| Level 6.84-9.3 mg/dL | Similar to predicate (e.g., < 3.6% CV) | Level 11.50 mg/dL: 1.7% CV |
| Level 11.50-16.3 mg/dL | Similar to predicate (e.g., < 3.3% CV) | |
| Imprecision (Urine CV%) | Level 20.5 mg/dL: 7.2% CV | |
| Level 20.5 mg/dL | Applicable only to ADVIA IMS | Level 32.4 mg/dL: 4.0% CV |
| Level 26.4-32.4 mg/dL | Similar to predicate (e.g., < 8.2% CV) | Level 45.2 mg/dL: 5.6% CV |
| Level 35.4-45.2 mg/dL | Similar to predicate (e.g., < 7.2% CV) | |
| Correlation (Serum vs. CHEM 1) | ||
| Regression Equation (Y=ADVIA IMS, X=CHEM 1) | Slope close to 1, Intercept close to 0 | Y=0.96X + 0.14 |
| Syx (mg/dL) | Low | 0.98 |
| r (correlation coefficient) | Close to 1 | 0.973 |
| Sample Range | Appropriate for clinical use | 1.5 - 19.7 mg/dL |
| Matrix Comparison (Plasma vs. Serum) | ||
| Regression Equation (Y=Plasma, X=Serum) | Slope close to 1, Intercept close to 0 | Y=1.01X + 0.06 |
| Syx (mg/dL) | Low | 0.16 |
| r (correlation coefficient) | Close to 1 | 0.989 |
| Sample Range | Appropriate for clinical use | 2.9 - 8.0 mg/dL |
| Correlation (Urine vs. CHEM 1) | ||
| Regression Equation (Y=ADVIA IMS, X=CHEM 1) | Slope close to 1, Intercept close to 0 | Y=1.11X - 3.1 |
| Syx (mg/dL) | Low | 4.0 |
| r (correlation coefficient) | Close to 1 | 0.992 |
| Sample Range | Appropriate for clinical use | 1.0 - 123.0 mg/dL |
| Interference (Serum) | Minimal clinical impact | Bilirubin (20 mg/dL): -7.9% effect Hemoglobin (500 mg/dL): +15.8% effect Lipids (Triglycerides 500 mg/dL): +36.7% effect |
| Interference (Urine) | Minimal clinical impact | Acetaminophen (500 mg/dL): +1.1% effect Ascorbic Acid (200 mg/dL): +10.9% effect Salicylate (500 mg/dL): -2.7% effect |
| Analytical Range | Clinically relevant | Serum/Plasma: 0 to 23 mg/dL Urine: 0 to 200 mg/dL |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Sizes:
- Imprecision (CV%): Not explicitly stated.
- Correlation (Serum vs. CHEM 1): N=60
- Matrix Comparison (Plasma vs. Serum): N=60
- Correlation (Urine vs. CHEM 1): 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
- Imprecision: Measured value from the ADVIA IMS system itself.
- Correlation: The comparison system (Technicon CHEM 1 Uric Acid) is used as the reference/ground truth.
- Matrix Comparison: Paired samples analyzed on the ADVIA IMS.
- Interfering Substances: The true concentration of Uric Acid in the sample prior to adding the interferent.
- Analytical Range: Established using materials with known Uric Acid concentrations.
Ask a specific question about this device
(211 days)
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.
Not Found
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.
Ask a specific question about this device
Page 1 of 1