OPUS ETHANOL

K972011 · Behring Diagnostics, Inc. · DIC · Jul 22, 1997 · Clinical Toxicology

Device Facts

• Record ID: K972011
• Device Name: OPUS ETHANOL
• Applicant: Behring Diagnostics, Inc.
• Product Code: DIC · Clinical Toxicology
• Decision Date: Jul 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3040
• Device Class: Class 2

Intended Use

OPUS Ethanol is an in vitro diagnostic thin film-based, fluorescence inhibition test for the quantitative measurement of ethanol in human serum or plasma as an aid in the diagnosis and treatment of alcohol intoxication and poisoning. OPUS Ethanol is intended for use with the OPUS analyzers.

Device Story

OPUS Ethanol is an in vitro diagnostic reagent system used with OPUS immunoassay analyzers. It measures ethanol concentration in human serum or plasma samples. The device utilizes thin film-based fluorescence inhibition technology to quantify ethanol levels (range 10-300 mg/dl). It is intended for use by healthcare professionals in clinical settings to assist in diagnosing and treating alcohol intoxication and poisoning. The analyzer processes the sample and provides a quantitative result, which clinicians use to inform patient management decisions. The solid-format thin film design offers advantages over liquid-format assays by mitigating sample volatility issues.

Clinical Evidence

Bench testing only. Precision: Intra-assay %CV 5.1%-8.7%; Inter-assay %CV 4.97%-8.73%. Accuracy by recovery: 92%-113%. Accuracy by correlation: Compared to a commercially available immunoassay using 50 serum samples (range 24.65-278.50 mg/dl), yielding a correlation coefficient of 0.995, y-intercept of 5.05, and slope of 0.89.

Technological Characteristics

Thin film-based fluorescence inhibition assay. Quantitative measurement of ethanol in serum/plasma. Designed for use with OPUS immunoassay analyzers. Solid-format reagent system.

Indications for Use

Indicated for the quantitative measurement of ethanol in human serum or plasma to aid in the diagnosis and treatment of alcohol intoxication and poisoning.

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

• Abbott TDx/TDxFLx REA Ethanol assay (K871645)

Submission Summary (Full Text)

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Kanzoll

Behring Diagnostics Inc. OPUS® Ethanol 510(k) Notification

JUL 2 2 1997

0000033

### Summary for 510(k) OPUS Ethanol

- Manufactures Name, Address, Telephone, and contact person, date of 1 . preparation :
Manufacturer:

Behring Diagnostics Inc. 151 University Avenue Westwood, MA 02090 617-320-3117 Attn .: Ruth Forstadt

Preparation date: May 29, 1997

- 2. Device Name/ Classification:
OPUS Ethanol:

Alcohol Test System

Classification Number: Class II (862.3040)

- 3 . Identification of the legally marketed device:
Abbott TDx/TDxFLx REA Ethanol assay (K871645).

#### 4 . Device Description:

OPUS Ethanol is a set of in vitro diagnostic reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of ethanol in human serum or plasma. Assay range is 10-300 mg/dl.

#### 5 . Device Intended Use:

OPUS Ethanol is an in vitro diagnostic thin film-based, fluorescence inhibition test for the quantitative measurement of ethanol in human serum or plasma as an aid in the diagnosis and treatment of alcohol intoxication and poisoning. OPUS Ethanol is intended for use with the OPUS analyzers.

CONFIDENTIAL

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#### Medical device to which equivalence is claimed and comparison 6. information:

The OPUS Ethanol assay is substantially equivalent in intended use to results obtained using the Abbott TDx/TDxFlx REA Ethanol assay. The Abbott TDx/TDxFlx REA Ethanol assay, like the proposed product, are based on a six level calibrator system. Both use the enzymes alcohol dehydrogenase and diaphorase to produce a formazan dye.

The OPUS Ethanol differs from the Abbott TDx/TDxFlx REA Ethanol assay in the technologies used. In the Abbott TDxTDxFlx REA Ethanol assay, an REA method is used, while a thin film-based fluorescence inhibition technology is used in the OPUS Ethanol test. Human whole blood, serum, plasma or urine can be tested with the Abbott TDx/TDxFlx REA Ethanol assay, but only human serum or plasma in the OPUS Ethanol test. Also, the Abbott TDx/TDxFlx REA Ethanol include tri-level controls for whole blood and serum, whereas the OPUS Ethanol test does not include controls. Additionally, because of the volatile nature of ethanol, the Abbott TDx/TDxFlx REA Ethanol assay, in its liquid format, can run no more than 12 samples at a time, while the OPUS Ethanol assay because of its solid format, is not limited in this way by sample volatility.

#### 7 . Device Performance Characteristics:

### Precision

Intra-assay precision was determined by the evaluation of three levels of control material in replicates of twenty (20) each. %CV ranged from 5.1% to 8.7%.

Inter-assay precision was determined by the evaluation of three levels of control material in duplicate, assayed over a five day period to total 20 replicates. %CV ranged from 4.97% to 8.73%.

# Accuracy by Recovery

Recovery was determined by making four dilutions of an elevated Bone AP patient sample into a normal human serum pool. The samples were assayed using OPUS Ethanol in duplicate. Percent recovery ranged from 92% to 113%

# Accuracy by Correlation

OPUS Ethanol was compared to a commercially available immunoassay by evaluation of 50 serum samples ranging from 24.65 to 278.50 mg/dl. A correlation coefficient of 0.995 was obtained with a y-intercept value of 5.05 and a slope of 0.89.

16:00 : 3

**CONFIDENTIAL**

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ruth Forstadt · Requlatory Affairs Associate Behring Diagnostics 151 University Avenue Westwood, Massachusetts 02090

K972011 Re : OPUS® Ethanol Test System Regulatory Class: II Product Code: DIC Dated: May 29, 1997 Received: May 30, 1997

Dear Ms. Forstadt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਜ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlationy action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.

JUL 22 1997

Image /page/2/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and a curved line representing its legs. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

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Page 2

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

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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Behring Diagnostics Inc. OPUS® Ethanol 510(k) Notification

of Page .

510(k) Number (if known):

Device Name:_

OPUS Ethanol Test System

# Indications For Use:

OPUS Ethanol is an in vitro diagnostic thin film-based, fluorescence inhibition test for the quantitative measurement of ethanol in human serum or plasma as an aid in the diagnosis and treatment of alcohol intoxication and poisoning. OPUS Ethanol is intended for use with the OPUS analyzers.

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(Division Sign-Off)
Division of Clinical Laborator Devices
510(k) Number. K972011

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

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use

(Optional Format 1-2-96) 000019

ONFIDEN