RANDOX BARBITURATE ASSAY

K041143 · Randox Laboratories, Ltd. · DIS · Nov 5, 2004 · Clinical Toxicology

Device Facts

• Record ID: K041143
• Device Name: RANDOX BARBITURATE ASSAY
• Applicant: Randox Laboratories, Ltd.
• Product Code: DIS · Clinical Toxicology
• Decision Date: Nov 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3150
• Device Class: Class 2

Intended Use

The evidence® Barbiturate assay has been designed for use only on the evidence® analyser for qualitative detection of barbiturates, in urine using a cutoff of 200 ng/ml. Qualitative results obtained can be utilized in the diagnosis and treatment of barbiturate use or overdose. This assay provides only a preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS. The Barbiturate Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions. The evidence® Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone and phenobarbital. There are 9 levels of calibrator. They have been developed for use in calibration of the evidence® system. The evidence® Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Device Story

The evidence® Barbiturate Assay is an in vitro diagnostic test for use on the evidence® analyzer. It detects barbiturates in urine samples at a 200 ng/ml cutoff. The system utilizes liquid calibrators (containing benzoylecgonine, amphetamine, methamphetamine, methadone, and phenobarbital) to calibrate the analyzer. The device is intended for use by qualified laboratory personnel in a clinical laboratory setting. The output is a qualitative result indicating the presence or absence of barbiturates above the cutoff. This result is preliminary and must be confirmed by a more specific method like GC/MS to assist in the diagnosis and treatment of drug use or overdose.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

In vitro diagnostic assay for use on the evidence® analyzer. Includes liquid calibrators with 9 levels containing benzoylecgonine, amphetamine, methamphetamine, methadone, and phenobarbital. Qualitative detection method.

Indications for Use

Indicated for the qualitative detection of barbiturates in human urine at a 200 ng/ml cutoff for the diagnosis and treatment of barbiturate use or overdose. For use by qualified laboratory personnel only. Preliminary results require confirmation by GC/MS.

Regulatory Classification

Identification

A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A barbiturate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 5 2004

Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories Ltd. 55 Diamond Road Crumlin, Co. Antrim United Kingdom BT29 4QY

Re: k041143

> Trade/Device Name: evidence® Barbiturate Assay evidence® Drugs of Abuse Calibrators Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: Class II Product Code: DIS, DKB Dated: October 26, 2004 Received: November 1, 2004

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. Ilsting 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter wilf anow you to oogin inding of substantial equivalence of your device to a legally prematicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, If you desire specific institution and advertising of your device, please contact the Office of In of quostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may other builts getain onal and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sincerely yours,

Cornelia B. Parks

Cornelia B. Rooks, MA Acting 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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## Indications for Use

## (041143 NOT KNOWN 510(k) Number (if known): evidence® BARBITURATE ASSAY AND Device Name: evidence® DRUGS OF ABUSE CALIBRATORS

Indications For Use:

The evidence® Barbiturate assay has been designed for use only on the evidence® analyser for qualitative detection of barbiturates, in urine using a cutoff of 200 ng/ml. Qualitative results obtained can be utilized in the diagnosis and treatment of barbiturate use or overdose.

This assay provides only a preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS.

The Barbiturate Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

## The evidence® Drugs of Abuse Calibrators.

The evidence®Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone and phenobarbital. There are 9 levels of calibrator. They have been developed for use in calibration of the evidence® system.

The evidence® Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Prescription Use (Part 21 CFR 801 Subpart D)

V

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

> Concurrence of C @RH, Office of In_Vitro Diagnostic Devices (OIVD)

Albert Schitz
Division Sign-Off

lvision Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K041143