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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.
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