ON.SITE ALCOHOL

K963197 · Ansys, Inc. · DML · Sep 19, 1996 · Clinical Toxicology

Device Facts

• Record ID: K963197
• Device Name: ON.SITE ALCOHOL
• Applicant: Ansys, Inc.
• Product Code: DML · Clinical Toxicology
• Decision Date: Sep 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3040
• Device Class: Class 2

Indications for Use

ON•SITE Alcohol is recommended for professional use only and is not intended for over-the-counter sale to the general public. Professional use includes applications in healthcare, corrections and drug treatment. ON•SITE Alcohol yields only a "qualitative" result. A positive result indicates that alcohol (ethanol) is present at a concentration of approximately 0.02% when performed according to the instructions. Confirmation of ON•SITE Alcohol results using gas chromatography is recommended if quantitative results are desired.

Device Story

ON•SITE Alcohol is a self-contained, disposable enzymatic test device for rapid qualitative detection of ethanol in saliva or urine. Used in professional settings (healthcare, corrections, drug treatment) by trained personnel. Device utilizes enzymatic reaction to produce observable color change indicating presence of alcohol at ~0.02% concentration. Modified version features adjusted reagent formulation to increase reaction time and shift detection limits compared to predecessor. Healthcare providers interpret visual results; positive results suggest presence of alcohol, with gas chromatography recommended for quantitative confirmation. Benefits include rapid, point-of-care screening for alcohol presence.

Clinical Evidence

Bench testing only. Accuracy and precision evaluated using twenty replicates of three ethanol controls (0.008%, 0.02%, 0.032% w/v). Sensitivity compared using ten replicates of eight controls (0.005% to 0.0225% w/v). Metrics included mean reaction time, standard deviation, and coefficient of variation. Results confirmed the modified device achieved the intended shift in reaction times and detection thresholds compared to the predicate.

Technological Characteristics

Disposable, self-contained enzymatic test device. Operates via chemical reaction producing visual qualitative output. Modified reagent formulation to adjust reaction kinetics. No electronic components, software, or external energy sources.

Indications for Use

Indicated for professional use in healthcare, corrections, and drug treatment settings to provide qualitative detection of ethanol in saliva or urine samples.

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

• ON•SITE Alcohol (predecessor)

Submission Summary (Full Text)

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K963197

# 510(k) SUMMARY

SEP 19 1996

1. Submitter: ANSYS, Inc.
Address: 2 Goodyear
Irvine, CA 92618
Telephone: [phone] Ext. 7915
Contact Person: Lorna Gamboa
Date Prepared: 7/9/96

2. Trade Name: ON•SITE Alcohol
Common Name: Alcohol Test System
Classification: Class II

3. Predicate Device Information:

The modified ON•SITE Alcohol test is being compared to its predecessor, the current ON•SITE Alcohol, both manufactured by ANSYS, Inc.

4. Description of the Device:

ON•SITE Alcohol is a self contained, disposable enzymatic test device that provides rapid detection of alcohol in saliva or urine. It includes all reagents and supplies necessary to perform the test.

5. Intended Use:

ON•SITE Alcohol is recommended for professional use only and is not intended for over-the-counter sale to the general public. Professional use includes applications in healthcare, corrections and drug treatment.

ON•SITE Alcohol yields only a "qualitative" result. A positive result indicates that alcohol (ethanol) is present at a concentration of approximately 0.02% when performed according to the instructions.

Confirmation of ON•SITE Alcohol results using gas chromatography is recommended if quantitative results are desired.

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6. Comparison of technological Characteristics:

The modified ON•SITE Alcohol uses the same technology as its predecessor. The only difference is in the formulation of one of its reagents. It has been modified to increase the reaction time, thus slightly raising the limit of detection.

7. Performance Characteristics and Supportive Data:

Accuracy and Precision

Accuracy and precision of the current and modified device was compared by running twenty replicates of three ethanol controls (0.008%, 0.02% and 0.032% w/v). Tests were timed and results were read at exactly 2 minutes. Results were reported as either positive or negative. In addition, reaction times for each test (i.e., time required to produce an observable positive result) were recorded. The mean, standard deviation and coefficient of variations were calculated and compared.

Results confirmed the desired shift in reaction time and detection levels as follows:

| % w/v EtOH | No. of Positives | | Mean Reaction Time | | Coefficient of Variation | |
| --- | --- | --- | --- | --- | --- | --- |
| | current | modified | current | modified | current | modified |
| 0.008 | 13 | 0 | 111 sec | 147 sec | 10.3% | 8.2% |
| 0.020 | 20 | 12 | 81 sec | 115 sec | 8.3% | 8.8% |
| 0.032 | 20 | 20 | 61 sec | 100 sec | 7.9% | 6.7% |

Sensitivity

The sensitivity of the current and modified device were also compared. Ten replicates of eight controls were tested using both devices. Reaction times were compared. Again, results confirmed the targeted shift in reaction times.

| % w/v EtOH | Mean Reaction Time | | Difference sec |
| --- | --- | --- | --- |
| | current | modified | |
| 0.005 | 1 min 47 sec | 2 min 41 sec | 54 |
| 0.0075 | 1 min 33 sec | 2 min 14 sec | 41 |
| 0.01 | 1 min 19 sec | 2 min 10 sec | 51 |
| 0.0125 | 1 min 21 sec | 1 min 53 sec | 32 |
| 0.015 | 1 min 19 sec | 1 min 42 sec | 23 |
| 0.0175 | 1 min 12 sec | 1 min 47 sec | 35 |
| 0.02 | 1 min 6 sec | 1 min 41 sec | 35 |
| 0.0225 | 1 min 6 sec | 1 min 29 sec | 23 |