(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 ( |
§ 862.3040 Alcohol test system.
(a)
Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.(b)
Classification. Class II.