RANDOX METHADONE ASSAY

K092272 · Randox Laboratories, Ltd. · DJR · Nov 18, 2010 · Clinical Toxicology

Device Facts

• Record ID: K092272
• Device Name: RANDOX METHADONE ASSAY
• Applicant: Randox Laboratories, Ltd.
• Product Code: DJR · Clinical Toxicology
• Decision Date: Nov 18, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3620
• Device Class: Class 2

Intended Use

The Randox Laboratories Ltd. Methadone Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of Methadone in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300 ng/mL for methadone. The Randox Methadone Assay has been developed for use on the Rx series analyzers, which includes the Rx Daytona and Rx Imola. This in vitro diagnostic device is intended for prescription use only. The semi-quantitative mode is for purposes of 1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC/MS, or, 2) permitting laboratories to establish quality control procedures. This assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatograph/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Device Story

Randox Methadone Assay; in vitro diagnostic enzyme immunoassay; detects methadone in human urine. Input: human urine sample; Reagents: murine monoclonal antibody/substrate reagent and enzyme-drug conjugate reagent. Principle: competitive immunoassay; drug in sample competes with enzyme-labeled drug for antibody binding sites; enzyme activity (G6PDH) inhibited when bound to antibody; free drug allows enzyme activity; NAD converted to NADH; absorbance change measured spectrophotometrically at 340nm. Output: qualitative or semi-quantitative methadone concentration. Used in clinical laboratories; operated by trained personnel on Rx Daytona or Rx Imola analyzers. Output used for preliminary screening; requires GC/MS confirmation for clinical decision-making. Benefits: rapid preliminary identification of methadone presence to guide further confirmatory testing and quality control.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic assay; liquid calibrators and controls; utilizes specific Randox analyzers; qualitative and semi-quantitative detection; 300ng/mL cutoff.

Indications for Use

Indicated for the qualitative and semi-quantitative detection of Methadone in human urine for prescription use. Intended for use on specific Randox analyzers to provide preliminary analytical results requiring confirmation by GC/MS.

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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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

Re: k092272

Trade/Device Name: Methadone Assay Regulation Number: 21 CFR 862.3620 1 Regulation Name: Methadone test system Regulatory Class: II Product Code: DJR, DKB, DIF Dated: November 2, 2010 Received: November 4, 2010

NOV 1 8 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 class II (Special Controls), 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 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). 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.

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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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

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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K092272

NOW 11 8 2010

# Indication for Use

510(k) Number (if known): k092272

Device Name:

METHADONE ASSAY, MULTIDRUG CALIBRATOR SET AND MULTIDRUG CONTROLS LEVEL 1 & 2

Indication For Use:

#### Randox Methadone Assay

The Randox Laboratories Ltd. Methadone Assay Is an in vitro diagnostic test for the qualitative and semiquantitative detection of Methadone in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300ng/ml for methadone. The Randox Methadone Assay has been developed for use on the seems analysers, which includes the day to name and the seemer ". This in vitro diagnostic device is intended for prescription use only.

The semi-quantitative mode is for purposes of

- (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS
- or

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- (2) permitting laboratories to establish quality control procedures.
This assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatographimass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the proliminary result is positive.

### Randox Multidrug Calibrator Set

The Randox Multidrug Calibrator Set consists of liquid calibrators containing Oxazepam and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Benzodiazepine (Oxazeoam) and Methadone assays on the ex-Amount . This in vitro diagnostic device is intended for prescription use only.

#### Randox Multidrug Controls, Level 1 & 2

The Randox Multidrug Controls, level 1 and 2 are liquid controls containing Oxazepam and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Benzodiazesine and Methadone assays on the forme analysers, which includes the JX day to na" and the ØXmail™ This in vitro diagnostic device is intended for prescription use only.

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

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

And/Or

Richard Shaw Officer

- Division Sign-Off Office of In Vitro Diagnostic Device Firaluation and Safety
510(k) K092272