ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

K023184 · Bayer Diagnostics Corp. · DIC · Nov 18, 2002 · Clinical Toxicology

Device Facts

• Record ID: K023184
• Device Name: ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
• Applicant: Bayer Diagnostics Corp.
• Product Code: DIC · Clinical Toxicology
• Decision Date: Nov 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3040
• Device Class: Class 2

Intended Use

The Bayer ADVIA IMS Ethanol (ETOH) assay is an in vitro diagnostic device intended to quantitatively measure ethanol concentration in human serum or plasma (Lithium Heparin). Measurement of ethanol is used in the diagnosis of ethanol (alcohol) toxicity and overdose.

Device Story

ADVIA IMS Ethanol assay is an in vitro diagnostic reagent system for quantitative measurement of ethanol in human serum or plasma (Lithium heparin). Used in clinical laboratory settings to assist physicians in diagnosing ethanol toxicity and overdose. The assay measures ethanol concentration; results are provided to healthcare providers to inform clinical decision-making regarding patient management for alcohol intoxication. Benefits include rapid, accurate assessment of blood alcohol levels.

Clinical Evidence

Bench testing only. Correlation study with 54 serum samples against Abbott/TDx showed R=0.999, slope 0.964, intercept -0.04. Plasma/serum comparison (N=50) showed R=1.000. Precision studies demonstrated total CVs ranging from 1.8% to 5.3% across levels 22.0-289.5 mg/dL. Interference testing showed minimal effect (<3%) from bilirubin, hemoglobin, and lipids.

Technological Characteristics

In vitro diagnostic reagent assay for use on the ADVIA IMS system. Analytical range: 0.7 to 500 mg/dL. Compatible with serum and Lithium heparin plasma. Quantitative measurement principle.

Indications for Use

Indicated for quantitative measurement of ethanol in human serum or plasma (Lithium heparin) to aid in the diagnosis of ethanol toxicity and overdose in patients.

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

• TDx/Ethanol

Submission Summary (Full Text)

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# NOV 1 8 2002

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Ethanol method for ADVIA® IMSTM

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

The assigned 510(k) number is: 5023184

### 1. Intended Use

The Bayer ADVIA IMS Ethanol (ETOH) assay is an in vitro diagnostic device intended to quantitatively measure ethanol concentration in human serum or plasma (Lithium Heparin). Measurement of ethanol is used in the diagnosis of ethanol (alcohol) toxicity and overdose.

#### 2. Predicate Device

| Product Name | | Reagent Part # Calibrator Part # |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| TDx/Ethanol | તે રેતા રેતા રાજ્યના પાકની ખેતી કરવામાં આવે છે. આ ગામમાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી | 8545 |

## 3. Device / Method

| Product Name | | Reagent BAN Calibrator BAN |
|--------------------------------------------------------------------------------------------------------------------------|----------|------------------------------|
| Comments of Address of Acres Company Complete Company La Province La Province La Pro-<br>Bayer ADVIA® IMSTM Ethanol<br>. | 01482481 | 08648547 |

#### Imprecision

| ADVIA IMS | TDx | | |
|---------------|-------------|---------------|-------------|
| Level (mg/dL) | Total CV(%) | Level (mg/dL) | Total CV(%) |
| 22.0 | 5.3 | 40 | 5.9 |
| 88.9 | 2.2 | 100 | 3.2 |
| 289.5 | 1.8 | 250 | 3.2 |

### Correlation (Y=ADVIA IMS, X=comparison system) =

| Specimen type | Comparison System (X) | N | Regression Equation | Syx (mg/dL) | R | Sample Range (mg/dL) |
|---------------------|-----------------------|----|---------------------|-------------|-------|----------------------|
| Serum | Abbott/TDx | 54 | $0.964 x - 0.04$ | 4.8 | 0.999 | 22.9 to 433.0 |
| Plasma(y), Serum(x) | ADVIA IMS | 50 | $1.005 x - 1.75$ | 2.99 | 1.000 | 10.0 to 516.2 |

#### Interfering Substances

| Interfering Substance | Interfering Sub.<br>Conc. (mg/dL) | Ethanol Conc<br>(mg/dL) | Effect<br>(% change) |
|--------------------------|-----------------------------------|-------------------------|----------------------|
| Bilirubin (unconjugated) | 25 | 98.2 | +1.2 |
| Bilirubin (conjugated) | 25 | 98.3 | +1.6 |
| Hemoglobin | 1000 | 94.9 | +2.7 |
| Lipids (Triglycerides) | 1000 | 95.8 | +2.0 |

#### Analytical Range

Serum/Plasma(Lithium heparine): 0.7 to 500 mg/dL

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Kenneth. Clark

11/6/02
Date

:

.

Kepalli T. Edids
Regulatory Aniars
Bayer Corporation 511 Benedict Avenue
Tarrytown, New York 10591-5097

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its head facing left and three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# NOV 1 8 2002

Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097

Re: k023184 Trade/Device Name: Ethanol Assay for the ADVIA® IMS™ Regulation Number: 21 CFR 862.3040 Regulation Name: Alcohol test system Regulatory Class: Class II Product Code: DIC; JIX Dated: September 20, 2002 Received: September 24, 2002

Dear Dr. Edds:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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 notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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#### 510(k) Number:

## Device Name: Ethanol Assay for the ADVIA® IMSTM

## Indications for Use:

The Bayer ADVIA IMS Ethanol method is an in vitro diagnostic device intended to quantitatively measure ethanol (alcohol) levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of ethanol toxicity and overdose.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K023184

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-CounterUse

(Optional Format 1-2-96)