RANDOX ETHANOL ASSAY

K092273 · Randox Laboratories, Ltd. · DIC · Nov 1, 2010 · Clinical Toxicology

Device Facts

• Record ID: K092273
• Device Name: RANDOX ETHANOL ASSAY
• Applicant: Randox Laboratories, Ltd.
• Product Code: DIC · Clinical Toxicology
• Decision Date: Nov 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3040
• Device Class: Class 2

Intended Use

The Randox Ethanol Assay is an in vitro diagnostic test for the quantitative analysis of Ethanol in human urine and serum on the forme analysers, which includes the JX day to na™ and the Amota™ analysers. The measurement of ethanol is used for the diagnosis and treatment of alcohol intoxication and poisoning. This is an in vitro diagnostic device intended for prescription use only. The Randox Ethanol Calibrator Set is intended for the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum on the December analysers which includes the X day to na™ and the 121mona™. The Randox Ethanol Control Set is intended for the quality control of the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum on the forme analysers which includes the Aday to na™ and the Mimola™ This is an in vitro diagnostic device intended for prescription use only.

Device Story

The Randox Ethanol Assay is an in vitro diagnostic reagent system for the quantitative measurement of ethanol in human urine and serum samples. It is designed for use on automated clinical chemistry analyzers (e.g., Daytona, Monaco). The assay utilizes enzymatic chemistry to determine ethanol concentration; the resulting absorbance change is measured photometrically by the analyzer. The device provides quantitative results to clinicians to assist in the diagnosis and management of alcohol intoxication and poisoning. It is intended for professional use in clinical laboratory settings.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by analytical performance data including precision/reproducibility (80 runs per concentration), linearity (r > 0.99), limit of detection/quantitation, and interference testing. Method comparison studies against the predicate device using clinical serum and urine samples showed high correlation (r > 0.99).

Technological Characteristics

Ready-to-use liquid reagents: Ethanol Buffer (tris, sodium azide) and Ethanol Enzyme Reagent (alcohol dehydrogenase, NAD, sodium azide, stabilizers). Kinetic spectrophotometric measurement at 340 nm. Calibrators/controls are human urine-based. Complies with CLSI guidelines EP5-A2, EP6-A, EP7-A2, EP17-A, and EP9-A2.

Indications for Use

Indicated for the quantitative analysis of ethanol in human urine and serum for the diagnosis and treatment of alcohol intoxication and poisoning. Intended for prescription 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.

Predicate Devices

• Randox Ethanol Assay (K092273)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. Inside the circle is an emblem that appears to be a stylized bird with three wing-like shapes.

Public Health Service

Randox Laboratories, Ltd. c/o Dr. Pauline Armstrong 55 Diamond RD. Crumlin County Antrim United Kingdom BT29 4QY

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Re: k092273

Trade/Device Name: Randox Ethanol Assay and Randox Ethanol Calibrators and Controls Regulation Number: 21 CFR 862.3040 Regulation Name: Alcohol test system Regulatory Class: Class II Product Code: DIC, DLJ and LAS · NOV - 1 2010 Dated: September 14, 2010 Received: September 16, 2010

Dear Dr. Armstrong:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

CA

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indication for Use

K092273 510(k) Number (if known):

Device Name:

# RANDOX ETHANOL ASSAY AND THE RANDOX ETHANOL CALIBRATOR/CONTROL SET

Indication For Use:

### Randox Ethanol Assay

The Randox Ethanol Assay is an in vitro diagnostic test for the quantitative analysis of Ethanol in human urine and serum on the forme analysers, which includes the JX day to na™ and the Amota™ analysers.

The measurement of ethanol is used for the diagnosis and treatment of alcohol intoxication and poisoning.

This is an in vitro diagnostic device intended for prescription use only.

### Randox Ethanol Calibrator Set

The Randox Ethanol Calibrator Set is intended for the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum on the December analysers which includes the X day to na™ and the 121mona™.

### Randox Ethanol Control Set

The Randox Ethanol Control Set is intended for the quality control of the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum on the forme analysers which includes the Aday to na™ and the Mimola™

This is an in vitro diagnostic device intended for prescription use only.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) *ke 092273*

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