ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221

K032461 · Lin-Zhi International, Inc. · DIC · Oct 3, 2003 · Clinical Toxicology

Device Facts

• Record ID: K032461
• Device Name: ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221
• Applicant: Lin-Zhi International, Inc.
• Product Code: DIC · Clinical Toxicology
• Decision Date: Oct 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3040
• Device Class: Class 2

Indications for Use

The Ethyl Alcohol Enzymatic Assay is a homogeneous enzymatic assay with 0 and 100 mg/dL (0.1%) alcohol calibrators. The assay is intended for use in the quantitative analyses of ethyl alcohol in human urine, serum or plasma. The assay is designed for professional use with a number of automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning. The Ethyl Alcohol Calibrators are intended for in vitro diagnostic use for the calibration of the Ethyl Alcohol Enzymatic Assay to determine the ethyl alcohol concentration in human urine, serum or plasma. The Ethyl Alcohol Controls are intended for in vitro diagnostic use for the validation of the Ethyl Alcohol Enzymatic Assay to determine ethyl apphol in human urine, serum or plasma.

Device Story

The device is a ready-to-use, liquid reagent, homogeneous enzymatic assay for the quantitative determination of ethyl alcohol in human urine, serum, or plasma. It utilizes alcohol dehydrogenase (ADH) to catalyze the conversion of ethyl alcohol and nicotinamide adenine dinucleotide (NAD) into acetaldehyde and NADH. The reaction is monitored spectrophotometrically at 340 nm, where the rate of NADH production is proportional to the ethyl alcohol concentration. The system includes aqueous phosphate buffer-based calibrators and controls. It is intended for professional use on automated clinical chemistry analyzers. Healthcare providers use the resulting concentration values to diagnose and manage alcohol intoxication and poisoning. The device provides a standardized, automated method for alcohol quantification, aiding in clinical decision-making regarding patient treatment.

Clinical Evidence

No clinical data. Bench testing only. Analytical performance included precision (within-run CV 0.75-1.17%, between-run CV 0.56-4.56%), linearity (3-600 mg/dL), and analytical specificity. Method comparison study (n=55) against predicate yielded R^2=0.995 and regression LZI = 0.991(predicate) + 11 mg/dL.

Technological Characteristics

Homogeneous enzymatic assay; liquid reagent; alcohol dehydrogenase (ADH) enzyme; spectrophotometric detection at 340 nm. Calibrators/controls are aqueous phosphate buffer-based. Compatible with automated clinical chemistry analyzers (e.g., Hitachi 717). Storage at 2-8°C.

Indications for Use

Indicated for quantitative analysis of ethyl alcohol in human urine, serum, or plasma to assist in the diagnosis and treatment of alcohol intoxication and poisoning in professional clinical settings.

Regulatory Classification

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.

Predicate Devices

• Ethyl Alcohol Assay (K923783)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K032461

B. Analyte:
Ethyl Alcohol (Ethanol)

C. Type of Test:
Enzymatic Alcohol Dehydrogenase for the quantitative measurement of ethyl alcohol.

D. Applicant:
Lin-Zhi International, Inc.

E. Proprietary and Established Names:
Ethyl Alcohol Enzymatic Assay

F. Regulatory Information:
1. Regulation section:
CFR 862.3040, Alcohol test system
2. Classification:
Class II
3. Product Code(s):
DIC, DKC, DNN
4. Panel:
Toxicology 91

G. Intended Use:
1. Indication(s) for use:
The Ethyl Alcohol Calibrators are intended for in vitro diagnostic use for the calibration of the Ethyl Alcohol Enzymatic Assay to determine the ethyl alcohol concentration in human urine, serum or plasma.

The Ethyl Alcohol Controls are intended for in vitro diagnostic use for the validation of the Ethyl Alcohol Enzymatic Assay to determine ethyl alcohol in human urine, serum or plasma.

The Ethyl Alcohol Enzymatic Assay is a homogeneous enzymatic assay with 0 and 100 mg/dL (0.1%) alcohol calibrators. The assay is intended for use in the quantitative analyses of ethyl alcohol in human urine, serum, or plasma. The assay is intended for professional use with a number of automated clinical chemistry analyzers.

Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

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2. Special condition for use statement(s):
Prescription use only

3. Special instrument Requirements:
Analyzers using this device must be able to maintain a constant temperature, pipette samples, mix reagents, measure enzyme rates at 340 nm, and time the reaction accurately.

H. Device Description:
The Ethyl Alcohol Assay calibrators have ethanol concentrations of 0 (negative) and 100 mg/dL in a phosphate buffer with sodium azide added as a preservative. The Ethyl Alcohol Assay controls have ethanol concentrations of 50 and 300 mg/dL in a phosphate buffer with sodium azide added as a preservative.

The Buffer Reagent (R1) contains tris-based buffer (50nM) with sodium azide. The Enzyme Reagent (R2) contains alcohol dehydrogenase (ADH), nicotinamide adenine dinucleotide (NAD, 10 nM), stabilizers, and sodium azide.

I. Substantial Equivalence Information:
1. Predicate device name(s):
Ethyl Alcohol Assay
2. Predicate K number(s):
K923783
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | Plasma, serum, urine | Same |
| Method principal | Enzymatic (ADH) | Same |
| Reagent components | Alcohol dehydrogenase, Nicotinamide adenine dinucleotide | Same |
| Within-run precision (CV%) | @50 mg/dL:1.1
@100 mg/dL:0.8
@300 mg/dL:1.1 | @50 mg/dL:2.7
@100 mg/dL:1.2
@300 mg/dL:0.6 |
| Between-run precision (CV%) | @50 mg/dL:4.6 | @50 mg/dL:9.0 |
| | Differences | |
| Item | Device | Predicate |
| Sensitivity | 3 mg/dL | 10 mg/dL |

J. Standard/Guidance Document Referenced (if applicable):

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None referenced

## K. Test Principle:

LZI’s Ethyl Alcohol Enzymatic Assay is a homogeneous ready-to-use liquid reagents based on the alcohol dehydrogenase (ADH) enzymatic reaction. In the presence of nicotinamide adenine dinucleotide (NAD), ADH converts ethyl alcohol to acetaldehyde and reduces NAD to NADH. The ethyl alcohol concentration is then directly proportional to the ADH activity. The enzyme activity is measured at 340 nm wavelength.

$$
\text{Ethyl Alcohol} + \text{NAD} \xrightarrow{\text{ADH}} \text{NADH} + \text{Acetaldehyde}
$$

## L. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

a. Precision/Reproducibility:

Within-run precision was calculated with data obtained using a Hitachi 717 (n=21 for all concentrations)

| Conc (mg/dL) | 50 | 100 | 200 | 300 |
| --- | --- | --- | --- | --- |
| Mean (mg/dL) | 50.0 | 99.1 | 194.8 | 281.6 |
| Std Dev | 0.59 | 0.77 | 1.47 | 3.21 |
| CV% | 1.17 | 0.78 | 0.75 | 1.14 |

Between-run precision was calculated with data obtained using a Hitachi 717 (n=12; 12 runs over a 3 weeks period)

| Conc (mg/dL) | 50 | 100 | 200 | 300 |
| --- | --- | --- | --- | --- |
| Mean (mg/dL) | 50.47 | 99.24 | 200.52 | 249.88 |
| Std Dev | 2.30 | 0.56 | 8.26 | 8.26 |
| CV% | 4.56 | 0.56 | 4.12 | 2.95 |

b. Linearity/assay reportable range:

3 to 600 mg/dL

c. Traceability (controls, calibrators, or method):

Controls and calibrators traceable to NIST ethanol standard

d. Detection limit:

3 mg/dL

e. Analytical specificity:

The following compounds were tested and the cross-reactivities measured:

| Compound | Concentration | % cross-reactivity |
| --- | --- | --- |
| Acetaldehyde | 2000 mg/dL | 0 |
| Acetone | 2000 mg/dL | 0 |

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| n-Butanol | 2000 mg/dL | 1.5 |
| --- | --- | --- |
| Ethylene glycol | 2000 mg/dL | 0 |
| Isopropanol | 2000 mg/dL | 0 |
| Methanol | 2000 mg/dL | 0 |
| n-Propanol | 2000 mg/dL | 11 |
| Hemoglobin | 800 mg/dL | 0 |
| Bilirubin | 30 mg/dL | 0 |
| Triglycerides | 1000 mg/dL | 0 |

f. Assay cut-off:

N/A

2. Comparison studies:

a. Method comparison with predicate device:

A correlation study between the device (LZI) and the predicate, where $n = 55$, yielded the following linear regression line:

$$
\mathrm{LZI} = 0.991(\text{predicate}) + 11\,\mathrm{mg/dL}
$$

$$
R^2 = 0.995
$$

b. Matrix comparison:

Both the device and the predicate measure ethyl alcohol in plasma, serum, or urine.

3. Clinical studies:

a. Clinical sensitivity:

N/A

b. Clinical specificity:

N/A

c. Other clinical supportive data (when $a$ and $b$ are not applicable):

N/A

4. Clinical cut-off:

N/A

5. Expected values/Reference range:

Ethyl alcohol is not present in detectable concentrations in healthy adults who have not consumed ethanol

M. Conclusion:

Based upon the information provided for the file, I recommend that the LZI Ethyl Alcohol Enzymatic Assay is substantially equivalent to the predicate device.