RANDOX OPIATES ASSAY

K041144 · Randox Laboratories, Ltd. · DJG · Nov 3, 2004 · Clinical Toxicology

Device Facts

• Record ID: K041144
• Device Name: RANDOX OPIATES ASSAY
• Applicant: Randox Laboratories, Ltd.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Nov 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

The evidence® Opiates test has been designed for use only on the evidence® analyser for qualitative detection of opiates in urine, using a cutoff concentration of 300ng/ml. Qualitative results obtained can be utilised in the diagnosis and treatment of opiate 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 Opiates 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 morphine sulphate pentahydrate. 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® Opiates Assay is an in vitro diagnostic test for qualitative detection of opiates in urine samples. It is designed exclusively for use on the evidence® analyser. The system utilizes liquid calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone, and morphine sulphate pentahydrate to calibrate the analyzer. The device is intended for use by qualified laboratory personnel in a clinical laboratory setting. The assay provides preliminary analytical results to assist clinicians in diagnosing and treating opiate use or overdose. Because results are preliminary, they must be confirmed by a more specific method, such as Gas Chromatography/Mass Spectrometry (GC/MS).

Clinical Evidence

No clinical studies performed. Performance established via bench testing: method comparison with 1336 urine samples against predicate EIA and GC/MS. Precision evaluated over 20 days (n=80) per NCCLS EP5-T2. Analytical sensitivity (limit of detection) determined as 20.3 normalized units. Specificity/cross-reactivity tested against various compounds; no interference observed for common substances per NCCLS EP7-A.

Technological Characteristics

In vitro diagnostic assay for use on the evidence® analyser. Includes 9 levels of liquid calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone, and morphine sulphate pentahydrate. Qualitative detection method with a 300ng/ml cutoff.

Indications for Use

Indicated for qualitative detection of opiates in urine for diagnosis and treatment of opiate use or overdose. For use by qualified laboratory personnel only. Not evaluated for point-of-care settings. Rx only.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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 U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 3 2004

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

Re: k041144

Trade/Device Name: evidence® Opiates Assay evidence® Drugs Of Abuse Calibrators Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG, DKB Dated: October 19, 2004 Received: October 25, 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, 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); 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) 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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 [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Seain M. Cooper, ULS, DVM.

Jean M. Cooper, MS, D.V.M. 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

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

## Device Name:__________________________________________________________________________________________________________________________________________________________________ evidence® DRUGS OF ABUSE CALIBRATORS

Indications For Use:

The evidence® Opiates test has been designed for use only on the evidence® analyser for qualitative detection of opiates in urine, using a cutoff concentration of 300ng/ml. Qualitative results obtained can be utilised in the diagnosis and treatment of opiate 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 Opiates 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 morphine sulphate pentahydrate. 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)

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 CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of _ 1

510(k) K041144