(140 days)
The Immunalysis Ethyl Alcohol Enzyme Assay is an in vitro diagnostic device for the quantitative analysis of ethyl alcohol (ethanol) in human urine, serum or plasma with automated clinical chemistry analyzers. The measurement of ethanol is used for the diagnosis and treatment of alcohol intoxication and poisoning. This assay is calibrated against ethyl alcohol. This device is intended for prescription use only.
The Immunalysis Ethyl Alcohol Assay is based on the oxidation of ethyl alcohol to acetaldehyde by alcohol dehydrogenase (ADH) and nicotinamide adenine dinucleotide (NAD) reduced to NADH resulting in an absorbance change measured spectrophotometrically at 340nm. The concentration of ethanol in the sample is directly proportional to the ADH activity.
The Immunalysis Ethyl Alcohol Enzyme Assay is an in vitro diagnostic device for the quantitative analysis of ethyl alcohol (ethanol) in human urine, serum, or plasma using automated clinical chemistry analyzers. The measurement of ethanol is used for the diagnosis and treatment of alcohol intoxication and poisoning.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit from Study Design) | Reported Device Performance |
|---|---|---|
| Limit of Blank (LoB) | Calculation from sixty (60) blank measurements of unaltered drug-free negative human urine, serum, and plasma. | Urine: 0.481 mg/dL |
| Serum: 0.668 mg/dL | ||
| Plasma: 0.652 mg/dL | ||
| Limit of Detection (LoD) | Testing of four samples per matrix (urine, serum, plasma) at concentrations in the range LoB to 4xLoB, in replicates of five, on two reagent lots over three days. | Urine: 1.3 mg/dL |
| Serum: 1.7 mg/dL | ||
| Plasma: 1.7 mg/dL | ||
| Limit of Quantitation (LoQ) | Four independent samples of each matrix spiked at the LoQ concentration were tested on two reagent lots, demonstrating suitable accuracy. | All matrices: 2.9 mg/dL (quantitatively determined with suitable accuracy) |
| Linearity/Recovery | Serially diluted samples (from high concentration EtOH to drug-free) covering 3 mg/dL to 600 mg/dL, tested in triplicate. Slope and r² values to demonstrate linearity. Recovery percentages. | Urine: Slope: 0.996, Intercept: -0.172, r²: 0.999 (Recovery 97.5% - 102.6%) |
| Serum: Slope: 0.978, Intercept: 2.869, r²: 0.999 (Recovery 96.6% - 104.8%) | ||
| Plasma: Slope: 0.970, Intercept: 0.307, r²: 0.999 (Recovery 95.1% - 106.1%) | ||
| Precision | Performed for 20 days, 2 runs per day in duplicate (N=80 for each matrix) on drug-free samples spiked with EtOH at 25, 75, 125, 150, 175, 200 mg/dL and calibrators/controls at 50, 100, 300 mg/dL. Spiked concentrations confirmed by GC-FID. CV% values for repeatability, between run, and within-laboratory. | Urine: Within-Laboratory CV% range from 1.5% to 1.8% for spiked samples. |
| Serum: Within-Laboratory CV% range from 2.0% to 3.2% for spiked samples. | ||
| Plasma: Within-Laboratory CV% range from 1.5% to 4.9% for spiked samples. | ||
| Specificity and Cross-Reactivity | Structurally and functionally similar compounds spiked into drug-free urine, serum, and plasma at levels yielding the equivalent of 10 mg/dL and 100 mg/dL EtOH. Verified ability of the device to exclusively determine certain drugs. | Low cross-reactivity for most tested compounds ( |
§ 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.