ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12

K974002 · Diagnostic Chemicals , Ltd. · DIC · Apr 1, 1998 · Clinical Toxicology

Device Facts

• Record ID: K974002
• Device Name: ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: DIC · Clinical Toxicology
• Decision Date: Apr 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3040
• Device Class: Class 2

Intended Use

For the quantitative determination of ethanol in serum, plasma or urine. For IN VITRO diagnostic use.

Device Story

Ethanol-SL Assay is an in vitro diagnostic reagent used for quantitative measurement of ethanol levels in human serum, plasma, or urine samples. Used in clinical laboratory settings by trained laboratory personnel. The assay utilizes enzymatic chemistry to measure ethanol concentration; results are typically determined via spectrophotometric analysis on automated clinical chemistry analyzers. Healthcare providers use these quantitative results to assess ethanol intoxication or exposure levels, aiding in clinical decision-making regarding patient management and treatment. The device provides objective data to support diagnostic assessment of alcohol presence in biological fluids.

Clinical Evidence

No clinical data provided; device is an in vitro diagnostic reagent evaluated via bench testing for analytical performance.

Technological Characteristics

Enzymatic assay for quantitative ethanol determination. Reagent-based chemistry designed for use on clinical chemistry analyzers. In vitro diagnostic device.

Indications for Use

Indicated for the quantitative determination of ethanol in serum, plasma, or urine for in vitro diagnostic use.

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.

Submission Summary (Full Text)

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Public Health Service

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APR - 1 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Karen Callbeck, R.T.B.Sc. Regulatory Affairs Coordinator Diagnostic Chemicals Limited 16 First Street West Royalty Industrial Park Charlottetown, PE Canada C1E, 1B0

K974002 Re : Ethanol-SL Assay Regulatory Class : II Product Code: DIC Dated: January 28, 1998 Received: January 30, 1998

Dear Ms. Callbeck:

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title-21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 requlatory 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 regulations.

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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 Litman

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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2974002 510(k) Number (if known): _

Device Name: Ethanol-SL Assay

## Indications For Use:

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For the quantitative determination of ethanol in serum, plasma or urine. For IN VITRO diagnostic use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices

Division of Clinical Laboratory D 510(k) Number _

Prescription Use _ (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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