The Ethanol assay is used for the quantitative analysis of ethyl alcohol (ethanol) in human serum, plasma, or urine. The Ethanol assay should be exclusively used to detect ethanol and not other alcohols such as isopropanol or methanol. Reactivity with compounds structurally unrelated to ethanol has not been observed.

Device Description

Ethanol is an in vitro diagnostic assay for the quantitative analysis of ethyl alcohol (ethanol) in human serum, plasma, or urine. The assay is based on an enzymatic reaction. Active enzyme converts NAD to NADH, resulting in an absorbance change that can be measured spectrophotometrically. The increase in absorbance at 340 nm is proportional to the concentration of alcohol in the specimen.

AI/ML Overview

This submission describes the "Ethanol" assay, an in vitro diagnostic device for the quantitative analysis of ethyl alcohol in human serum, plasma, or urine. The study presented aims to demonstrate substantial equivalence to a predicate device, the Emit® II Plus Ethyl Alcohol assay (K993980).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Predicate Performance)	Reported Device Performance (Ethanol Assay)
Correlation with Predicate Device (Emit® II Plus Ethyl Alcohol assay on SYVA 30R Analyzer)	Acceptable correlation demonstrated.
- Serum: Not explicitly stated as a numerical criterion, but the predicate's performance implies a high correlation is expected.	- Serum: Correlation coefficient = 0.996, slope = 1.00, Y-intercept = -1.87 mg/dL
- Urine: Not explicitly stated as a numerical criterion, but the predicate's performance implies a high correlation is expected.	- Urine: Correlation coefficient = 0.997, slope = 1.01, Y-intercept = -4.85 mg/dL
Precision (Implied from predicate or general assay expectations)	Precision studies conducted.
- Within-run Total %CV: Implied to be low for similar assays.	- Low control: 5.1% Total %CV
- Within-run Total %CV: Implied to be low for similar assays (e.g., around 1-5% for calibrators/controls).	- 100 mg/dL calibrator/control: 2.8% Total %CV
- Within-run Total %CV: Implied to be low for similar assays.	- High control: 1.7% Total %CV
Assay Range (Implied from predicate or general assay expectations)	10 to 600 mg/dL
Limit of Quantitation (Sensitivity) (Implied from predicate or general assay expectations)	5 mg/dL

Note: The acceptance criteria are not explicitly defined as pass/fail thresholds in the provided text but are inferred from the need to demonstrate "substantially equivalent performance" to the predicate device. The presented performance characteristics are typical metrics for demonstrating equivalence in IVD assays.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific number of human serum or urine samples used in the comparative performance studies to generate the correlation data (correlation coefficients, slopes, and y-intercepts). It only mentions "Comparative performance studies were conducted." The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.

For the precision studies, "three levels of control material" were used for the within-run study. The number of replicates for each level is not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The "Ethanol" assay is an in vitro diagnostic (IVD) test that quantifies a biomarker (ethyl alcohol concentration). The "ground truth" for such devices is typically established by comparing its performance to a reference method or another legally marketed device (the predicate device in this case), or by using known concentrations in control materials. It does not involve interpretation by human clinicians or experts for ground truth establishment in the same way an imaging or pathology device might require.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (e.g., 2+1, 3+1) is not applicable here. Adjudication is used to resolve discrepancies in independent interpretations by multiple experts, typically for qualitative or semi-quantitative diagnostic tests where human judgment is involved. For a quantitative IVD assay like the Ethanol assay, the comparison is directly between the numerical results of the new device and the predicate device (or known concentrations).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. MRMC studies are used to evaluate the impact of an AI-powered diagnostic aid on human reader performance (e.g., radiologists interpreting images). The "Ethanol" assay is an automated in vitro diagnostic test for quantifying a biomarker and does not involve human interpretation in the diagnostic process beyond performing the test and reviewing results. Therefore, there is no "human reader improvement with AI vs without AI assistance" to measure.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The entire study presented is a standalone performance evaluation of the "Ethanol" assay. The device itself is an automated enzymatic assay. The performance characteristics (correlation, precision, range, sensitivity) are inherently "standalone" in that they describe the capability of the device itself to accurately measure ethanol concentration, without requiring active human interpretation of its diagnostic output (beyond standard laboratory procedures).

7. The Type of Ground Truth Used

The ground truth used for the comparative performance studies was the results obtained from the predicate device, the Emit® II Plus Ethyl Alcohol assay on the SYVA 30R Analyzer. For the precision studies, the ground truth was the known concentrations of the control materials (low control, 100 mg/dL calibrator/control, and high control).

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This submission describes an in vitro diagnostic that uses an enzymatic reaction. This type of assay does not typically involve machine learning algorithms that require "training sets" in the conventional sense (i.e., large datasets used to train a model). Instead, it relies on established biochemical principles and calibration procedures.

9. How the Ground Truth for the Training Set Was Established

As noted above, this device does not utilize a training set in the machine learning context. The "ground truth" relevant to the development and calibration of such an enzymatic assay would historically involve:

Known concentrations of analyte: Prepared standards and calibrators with precisely measured ethanol concentrations.
Reference methods: Historical or established reference methods for measuring ethanol.

These elements would be used during the assay's development and manufacturing to establish its analytical performance characteristics and ensure it accurately measures ethanol. The specific details of how these were established are not provided in this 510(k) summary, as it is focused on demonstrating equivalence to the predicate, not the de novo development process.

Summary

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510(k) Summary

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive MS 8-21 Irving, Texas 75038

Contact Person Alicia Simpson Senior Regulatory Affairs Specialist Regulatory Affairs (972) 518-7864 Fax (972) 518-6533

Date of Preparation of this Summary:	October 23, 2001
Device Trade or Proprietary Name:	Ethanol
Device Common/Usual Name or Classification Name:	Ethyl Alcohol
Classification Number/Class:	DML/Class II

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K013538_

Test Description:

Substantial Equivalence:

The Ethanol assay is substantially equivalent to the Emit® II Plus Ethyl Alcohol assay (K993980) on the SYVA®-30R Analyzer.

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Both assays yield similar Performance Characteristics.

Similarities:

Both assays are in vitro immunoassays. .
Both assays can be used for the quantitative analysis of ethyl alcohol. .
Both assays yield similar results. .
Both assays are based on an enzymatic reaction. .

Differences:

There is no difference. .

Intended Use:

The Ethanol assay is used for the quantitative analysis of ethyl alcohol (ethanol) in human serum, plasma, or urine.

Performance Characteristics:

Comparative performance studies were conducted using the AEROSET® System. The Ethanol assay method comparison yielded acceptable correlation with the Emit® II Plus Ethyl Alcohol assay on the SYVA 30R Analyzer. For serum, the correlation coefficient = 0.996, slope = 1.00, and the Y-intercept = - 1.87 mg/dL. For urine the correlation coefficient = 0.997, slope = 1.01, and the Y-intercept = -4.85 mg/dL. Precision studies were conducted using the Ethanol assay. A within-run study was performed using three levels of control material. The total %CV for the low control is 5.1%, 100 mg/dL calibrator/control is 2.8%, and the high control is 1.7%. The Ethanol assay range is 10 to 600 mg/dL. The limit of quantitation (sensitivity) of the Ethanol assay is 5 mg/dL. These data demonstrate that the performance of the Ethanol assay is substantially equivalent to the performance of the Emit II Plus Ethyl Alcohol assay on the SYVA-30R Analyzer.

ETHANOL 510(k) October 23, 2001 Ethan_5_R1.doc

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Conclusion:

The Ethanol assay is substantially equivalent to the Emit II Plus Ethyl Alcohol assay on the SYVA-30R Analyzer as demonstrated by results obtained in the studies.

ETHANOL 510(k)
October 23, 2001 Ethan_5_R1.doc

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Alicia Simpson Senior Regulatory Affairs Specialist Abbott Laboratories 1920 Hurd Drive Irving, TX 75038

DEC 1 4 2001

K013538 Re: Trade/Device Name: Ethanol Regulation Number: 21 CFR 862.3040 Regulation Name: Alcohol Test System Regulatory Class: Class II Product Code: DML Dated: October 23, 2001 Received: October 24, 2001

Dear Ms. Simpson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaren be (2) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars actual to the Medical Device Americal Partic Commerce provision of May 20, 1978, are oncernance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (110) that ao nov requent to the general controls provisions of the Act. The Tou may, merelove, manel of the Act include requirements for annual registration, listing of general controls provisions of assisted, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it IT your device is classified (600 a00 rols. Existing major regulations affecting your device can may oc subject to back access as a regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that I Dris issuation that your device complies with other requirements of the Act that I Dri has intact a and regulations administered by other Federal agencies. You must or any I catal subdicalled and regaranents, including, but not limited to: registration and listing (21 comply with an the Not 811 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis lower will and my of substantial equivalence of your device to a legally marketed notification. The I Drice results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (201) 594-4639 the office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K013538 510(k) Number (if known): ___

Device Name: _________________________________________________________________________________________________________________________________________________________________ Ethanol

Indications For Use:

Ethan_5_R1.doc

Thomas A. Smith for Jean Cooper

(Division Sign-Of Division of Clinical Laboratory Devices 1-013538 510(k) Number.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use/ Over-The-Counter Use OR (Per 21 CFR 801.109) (Optional Format 1-2-96) ETHANOL 510(k) October 23, 2001

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Regulation Number and Section

§ 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.