ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS

K990516 · Emd Chemicals, Inc. · DNN · Mar 31, 1999 · Clinical Toxicology

Device Facts

• Record ID: K990516
• Device Name: ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
• Applicant: Emd Chemicals, Inc.
• Product Code: DNN · Clinical Toxicology
• Decision Date: Mar 31, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended Use

The Ethyl Alcohol Clinical Standard Solutions are intended for use in the calibration and standardization of instruments and methods for the determination of Ethyl alcohol in whole blood or serum. The Standard Solutions may also be used for validation of the status and the standardization of instruments and methods and/or control materials.

Device Story

Ethyl Alcohol Clinical Standard Solutions are liquid chemical reference materials used in clinical laboratories. These solutions contain known, precise concentrations of ethyl alcohol. They are utilized by laboratory technicians to calibrate analytical instruments and validate the accuracy of testing methods for blood or serum alcohol analysis. By providing a stable reference point, these standards ensure that clinical assays produce reliable, standardized results for patient samples. The device does not perform analysis itself but serves as an essential quality control tool to maintain the performance of diagnostic equipment, thereby supporting accurate clinical decision-making regarding alcohol levels in patients.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid chemical standard solutions containing ethyl alcohol. Designed for use with clinical laboratory instrumentation for quantitative analysis of blood/serum alcohol. No electronic, software, or mechanical components.

Indications for Use

Indicated for use in clinical laboratory settings for the calibration, standardization, and validation of analytical instruments and methods used to measure ethyl alcohol concentrations in human whole blood or serum samples.

Regulatory Classification

Identification

A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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MAR 3 1 1999

Anna G. Bentley, Ph.D. Director, RA/QA EM Science 480 S. Democrat Road Gibbstown, New Jersey 08027

Re: K990516 Trade Name: Ethyl Alcohol Calibrator Regulatory Class: II Product Code: DNN Dated: February 16, 1999 Received: February 18, 1999

Dear Dr. Bentley:

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 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). 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 Regulations, 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 Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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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/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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K990516 510 (k) NUMBER (IF KNOWN):

Ethyl Alcohol Clinical Standard Solutions DEVICE NAME:

INDICATIONS FOR USE:

The Ethyl Alcohol Clinical Standard Solutions are intended for use in the calibration and The Ethyl Alcohol Clinical Standad Solutions or the determination of Ethyl alcohol in
standardization of instruments and methods for validation of the standardization of instruments and themous the used for validation of the
whole blood or serum. The Standard Solutions may also be used for validation of the
status and the S whole blood of Scrain: The Standards and/or control materials.

Ethyl Alcohol Calibrators 510(k)

2/16/99 EM Science, Gibbstown NJ

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K950516

(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)

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