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510(k) Data Aggregation
(55 days)
The Bayer ADVIA IMS Ethanol (ETOH) assay is an in vitro diagnostic device intended to quantitatively measure ethanol concentration in human serum or plasma (Lithium Heparin). Measurement of ethanol is used in the diagnosis of ethanol (alcohol) toxicity and overdose.
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The Bayer ADVIA® IMS™ Ethanol assay is an in vitro diagnostic device intended to quantitatively measure ethanol concentration in human serum or plasma (Lithium Heparin). This assay is used in the diagnosis of ethanol (alcohol) toxicity and overdose.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate Device TDx) | Reported Device Performance (ADVIA® IMS™ Ethanol) |
|---|---|---|
| Imprecision (Total CV%) | ||
| Level ~40 mg/dL | 5.9% | 5.3% (at 22.0 mg/dL) |
| Level ~100 mg/dL | 3.2% | 2.2% (at 88.9 mg/dL) |
| Level ~250 mg/dL | 3.2% | 1.8% (at 289.5 mg/dL) |
| Correlation (vs. Predicate TDx - Serum) | ||
| Regression Equation | Not explicitly stated, but high R-value expected | Y = 0.964x - 0.04 |
| Syx (mg/dL) | Not explicitly stated | 4.8 |
| R | Not explicitly stated, but close to 1 expected | 0.999 |
| Sample Range (mg/dL) | Not explicitly stated | 22.9 to 433.0 |
| Correlation (Plasma vs. Serum - ADVIA IMS) | ||
| Regression Equation | Not explicitly stated | Y = 1.005x - 1.75 |
| Syx (mg/dL) | Not explicitly stated | 2.99 |
| R | Not explicitly stated, but close to 1 expected | 1.000 |
| Sample Range (mg/dL) | Not explicitly stated | 10.0 to 516.2 |
| Interfering Substances | Minimal interference (< ~10% change) | |
| Bilirubin (unconjugated, 25 mg/dL) | Not explicitly stated | +1.2% (at 98.2 mg/dL Ethanol) |
| Bilirubin (conjugated, 25 mg/dL) | Not explicitly stated | +1.6% (at 98.3 mg/dL Ethanol) |
| Hemoglobin (1000 mg/dL) | Not explicitly stated | +2.7% (at 94.9 mg/dL Ethanol) |
| Lipids (Triglycerides, 1000 mg/dL) | Not explicitly stated | +2.0% (at 95.8 mg/dL Ethanol) |
| Analytical Range | Not explicitly stated | 0.7 to 500 mg/dL |
2. Sample Sizes Used for the Test Set and Data Provenance
- Correlation (Serum vs. Abbott/TDx): 54 samples (N=54)
- Correlation (Plasma vs. Serum using ADVIA IMS): 50 samples (N=50)
The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the context of a 510(k) submission for a diagnostic device, it is typically expected that studies are prospective or, if retrospective, well-controlled with banked samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is an in vitro diagnostic device measuring a chemical analyte (ethanol concentration). The "ground truth" for such measurements is established by validated reference methods or predicate devices, not by expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the "ground truth" is a quantitative measurement, not a subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study (MRMC) is typically used for imaging-based diagnostic devices where human readers interpret images. For an in vitro diagnostic assay, the comparison is made against a predicate device or reference method's quantitative output.
6. Standalone Performance Study
Yes, in essence. The imprecision, interfering substances, and analytical range studies assess the algorithm's (or assay's) performance independently of human interpretation.
The correlation studies also demonstrate the standalone performance of the ADVIA IMS Ethanol assay in comparison to a predicate device and also for different sample types (plasma vs serum) using the ADVIA IMS system itself.
7. Type of Ground Truth Used
The ground truth for the performance studies was established by:
- Predicate Device Comparison: The Abbott/TDx system served as the comparison system for the serum correlation study.
- Internal Comparison: For the plasma versus serum correlation, the ADVIA IMS itself was used to compare ethanol levels in matched plasma and serum samples.
- Known Concentrations: For imprecision and interfering substances studies, known concentrations of ethanol and interfering substances would have been used.
8. Sample Size for the Training Set
The document does not specify a separate "training set" sample size. For an in vitro diagnostic assay, development and validation typically involve extensive internal testing before final performance studies are conducted. The provided data represents validation studies, not typically a "training set" in the machine learning sense. Statistical models or algorithms within such devices are generally based on established chemical principles rather than iterative machine learning from large datasets.
9. How the Ground Truth for the Training Set was Established
Not explicitly stated or applicable in the conventional machine learning sense. The "ground truth" for developing such a chemical assay would involve:
- Chemical Principles: The assay is based on known biochemical reactions for ethanol detection.
- Reference Materials: Using validated reference materials with known ethanol concentrations for calibration and quality control.
- Method Optimization: Through extensive laboratory experimentation and optimization, ensuring that the assay accurately measures ethanol across its intended range.
- Comparison to Established Methods: During development, the assay would be compared to existing, well-validated methods to ensure accuracy and precision.
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