RANDOX METHADONE ASSAY

K040570 · Randox Laboratories, Ltd. · DJR · May 10, 2004 · Clinical Toxicology

Device Facts

• Record ID: K040570
• Device Name: RANDOX METHADONE ASSAY
• Applicant: Randox Laboratories, Ltd.
• Product Code: DJR · Clinical Toxicology
• Decision Date: May 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3620
• Device Class: Class 2

Intended Use

The evidence methadone test has been designed for use only on the evidence analyzer for qualitative detection of methadone in urine using a cutoff concentration of 300 ng/mL. Qualitative results obtained can be utilized in the diagnosis and treatment of methadone use or overdose. Evidence Drugs of Abuse Calibrators are liquid Calibrators containing Methadone. There are nine levels of calibrator. They have been developed for the system.

Device Story

The 1 Methadone Assay is an in vitro diagnostic test for the qualitative detection of methadone in human urine. It is designed for exclusive use on the 1 analyser. The system utilizes liquid Evidence Drugs of Abuse Calibrators (9 levels) to calibrate the assay. The device is intended for use by qualified laboratory personnel in a clinical laboratory setting. The assay provides preliminary analytical results, which must be confirmed by a more specific method such as Gas Chromatography/Mass Spectrometry (GC/MS). The output assists clinicians in the diagnosis and treatment of methadone use or overdose.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic assay for urine analysis; utilizes 9-level liquid calibrators; qualitative detection via 300 ng/mL cutoff; designed for use on the 1 analyser system.

Indications for Use

Indicated for qualitative detection of methadone in human urine at a 300 ng/mL cutoff. Used for diagnosis and treatment of methadone use or overdose. Rx use only. Not evaluated for point-of-care settings.

Regulatory Classification

Identification

A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.

Special Controls

*Classification.* Class II (special controls). A methadone 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 & Human Services. The logo features a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 0 2004

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

Re: k040570

Trade/Device Name: 1 Methadone Assay and Evidence Drugs of Abuse Calibrators Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR, DKB Dated: March 1, 2004 Received: March 4, 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,

Javin M. Cooper, MS, DVM.

Tean 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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K040570

MAY 1 0 2004

# Indications for Use

## 510(k) Number (if known): NOT KNOWN

#### 1 METHADONE ASSAY AND EVIDENCE DRUGS OF Device Name: ABUSE CALIBRATORS

Indications For Use:

## 1 Methadone Assay

The 1 methadone assay has been designed for use only on the 1 analyser for qualitative detection of methadone, a narcotic pain-relieving drug, in urine using a cutoff concentration of 300 ng/mL. Qualitative results obtained can be utilised in the diagnosis and treatment of methadone 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 1 Methadone Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

## Evidence Drugs of Abuse Calibrators

The Evidence Drugs of Abuse Calibrators are liquid Calibrators containing Methadone. There are 9 levels of calibrator.

They have been developed for use in calibration of the 1 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) X

AND/OR

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

Alberto Ca

(PLEASE DO NOT WRITERED SHOP CONTINUE ON ANOTHER PAGE IF NEEDED)

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k040570