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510(k) Data Aggregation
(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 (<0.3% to <3.3%). n-Propanol showed higher cross-reactivity (Urine: 16.7% at 10 mg/dL, 9.8% at 100 mg/dL; Serum/Plasma: 11.1% at both 10 mg/dL and 100 mg/dL). |
| Interference (Structurally Unrelated Compounds) | Structurally unrelated compounds spiked into drug-free urine containing EtOH at 10 mg/dL and 100 mg/dL. Assay performance to be unaffected. | Assay performance was unaffected by all tested compounds at specified concentrations (e.g., Acetaminophen 500,000 mg/dL, Caffeine 500,000 mg/dL, Ibuprofen 100,000 mg/dL, etc.). |
| Interference (Endogenous Compounds & Urine Preservatives) | Endogenous compounds and urine preservatives spiked into drug-free urine containing EtOH at 10 mg/dL and 100 mg/dL. Assay performance to be unaffected. | Assay performance was unaffected by all tested endogenous compounds (e.g., Ascorbic Acid 1.5 g/dL, Glucose 2.0 g/dL, Hemoglobin 0.3 g/dL) and urine preservatives (e.g., Boric Acid 1% w/v, Sodium Azide 1% w/v). |
| Interference (Interferents in Serum & Plasma) | Potential interfering substances and anticoagulants spiked into drug-free serum and plasma containing EtOH at 10 mg/dL and 100 mg/dL. Assay performance to be unaffected. | Assay performance was unaffected by all tested compounds in serum/plasma (e.g., Bilirubin total 60-80 mg/dL, Hemoglobin 62.5-1000 mg/dL, Triglycerides 500 mg/dL) and anticoagulants (e.g., Heparin 3 U/mL, EDTA 2 mg/mL). |
| Interference (pH) | Device performance tested over a range of urine pH values (3.0 to 11.0) with EtOH at 10 mg/dL and 100 mg/dL. No interference observed. | No interference observed at urine pH values ranging from 3.0 to 11.0. |
| Interference (Specific Gravity) | Device performance tested over a range of physiologically relevant urine specific gravity values (1.000 to 1.030) with EtOH at 10 mg/dL and 100 mg/dL. No interference observed. | No interference observed at urine specific gravity values ranging from 1.000 to 1.030. |
| Calibration Duration | Drug-free negative urine spiked with EtOH at 10, 100, and 300 mg/dL tested up to 14 days, using an initial two-point calibration. Test results met acceptance criteria. | Calibration is stable for 14 days. Recommended frequency of calibration is 14 days. |
| Specimen Stability | Urine, serum, and plasma samples spiked with EtOH at 100 mg/dL and 300 mg/dL, stored in industry standard collection containers and tested at various time points and temperatures (up to 30°C and 2°C - 8°C). | Urine: Stable up to 14 days at 30°C, up to 6 months at 2°C - 8°C. Serum: Stable up to 10 days at 30°C, up to 14 days at 2°C - 8°C. Plasma: Stable up to 3 days at 30°C, up to 6 days at 2°C - 8°C. |
| Method Comparison | Comparison against a predicate device using de-identified, unaltered leftover clinical urine, serum, and plasma samples. Correlation coefficient (r²) and slope/intercept values. | Urine: n=80, Slope: 1.0284, Intercept: -2.7848, r²: 0.9964 (Range 3-600 mg/dL) Serum: n=76, Slope: 1.0067, Intercept: -5.8802, r²: 0.9948 (Range 3-600 mg/dL) Plasma: n=64, Slope: 1.0595, Intercept: -7.3902, r²: 0.9932 (Range 3-600 mg/dL) |
2. Sample Size Used for the Test Set and the Data Provenance
- Limit of Blank (LoB): 60 blank measurements for urine, 60 for serum, 60 for plasma samples.
- Limit of Detection (LoD): 4 samples per matrix, each tested in replicates of 5 (20 measurements per matrix).
- Limit of Quantitation (LoQ): 4 independent samples per matrix.
- Linearity/Recovery: 12 concentrations for urine, 12 for serum, 12 for plasma, each tested in triplicate.
- Precision: 80 samples per matrix (urine, serum, plasma) at each of 10 concentration levels (25, 50, 75, 100, 125, 150, 175, 200, 300 mg/dL, plus 0 mg/dL for urine and 0.4 mg/dL for serum and 0.2 mg/dL for plasma). This implies 800 data points per matrix for precision.
- Specificity and Cross-Reactivity: Compounds tested at two concentrations (10 mg/dL and 100 mg/dL equivalent EtOH) in urine, serum, and plasma.
- Interference (Structurally Unrelated Compounds): Numerous compounds tested at specific concentrations with EtOH at 10 mg/dL and 100 mg/dL in urine.
- Interference (Endogenous Compounds & Urine Preservatives): Various compounds tested with EtOH at 10 mg/dL and 100 mg/dL in urine.
- Interference (Interferents in Serum & Plasma) & Anticoagulants: Various compounds and anticoagulants tested with EtOH at 10 mg/dL and 100 mg/dL in serum and plasma.
- Interference (pH): Test samples prepared in drug-free urine containing EtOH at 10 mg/dL and 100 mg/dL, tested across a pH range of 3.0 to 11.0.
- Interference (Specific Gravity): Test samples prepared in drug-free urine containing EtOH at 10 mg/dL and 100 mg/dL, tested across specific gravity range of 1.000 to 1.030.
- Calibration Duration: Drug-free negative urine spiked with EtOH at 10, 100, and 300 mg/dL tested at various time points up to 14 days.
- Specimen Stability: Urine, serum, and plasma samples spiked with EtOH at 100 mg/dL and 300 mg/dL, tested at various time points and temperatures.
- Method Comparison: 80 de-identified, unaltered leftover clinical urine samples; 76 de-identified, unaltered leftover clinical serum samples; 64 de-identified, unaltered leftover clinical plasma samples.
Data Provenance:
The data provenance specifies "unaltered drug-free negative human urine, serum, and plasma" for many studies and "de-identified, unaltered leftover clinical urine samples," "de-identified, unaltered leftover clinical serum samples," and "de-identified, unaltered leftover clinical plasma samples obtained from clinical testing laboratories" for the method comparison. This indicates the data is retrospective and derived from human biological samples, likely from clinical settings. The country of origin is not explicitly stated, but given the FDA submission, it is typically expected to be from studies conducted under US or internationally recognized standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of device (in vitro diagnostic assay for chemical analysis) does not typically involve human expert consensus for establishing ground truth in the same way an imaging AI algorithm would. Instead, the ground truth for samples (e.g., spiked concentrations, known concentrations in clinical samples) is established through reference methods or highly accurate laboratory techniques.
For the precision study, spiked concentrations were confirmed by Gas Chromatography - Flame Ionization Detector (GC-FID), which is a highly accurate analytical method.
4. Adjudication Method for the Test Set
Not applicable for this type of in vitro diagnostic assay. Ground truth is established by analytical methods, not human adjudication of subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the device operates in a standalone (algorithm only) manner. It is an automated clinical chemistry analyzer which quantitatively measures ethyl alcohol. Its performance is evaluated directly through the performance studies described (LoB, LoD, LoQ, Linearity, Precision, Specificity, Interference, etc.). These studies quantify the device's accuracy and reliability in generating results, without human interpretation of the assay's direct output.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for this device is based on:
- Known concentrations of spiked ethyl alcohol in various matrices (urine, serum, plasma).
- Reference analytical methods, specifically Gas Chromatography - Flame Ionization Detector (GC-FID), to confirm spiked concentrations and potentially for method comparison where samples were cross-validated.
- Comparison to a legally marketed predicate device for method comparison, which itself would have established performance characteristics against accepted methods.
8. The Sample Size for the Training Set
Not applicable. This device is an in vitro diagnostic assay based on an enzymatic reaction, not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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