RANDOX ECSTASY (MDMA) ASSAY

K092275 · Randox Laboratories, Ltd. · DKZ · Mar 1, 2011 · Clinical Toxicology

Device Facts

• Record ID: K092275
• Device Name: RANDOX ECSTASY (MDMA) ASSAY
• Applicant: Randox Laboratories, Ltd.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Mar 1, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The Randox Laboratories Ltd. Ecstasy Assay is an in vitro diagnostic test for the detection of MDMA in human urine with a cut off concentration of 500ng/ml, for use on the Unean of the uneath of Mondal analysers in qualitative or semi-quantititive mode. The assay is calibrated against MDMA. 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 difution of the specimen for confirmation by a confirmatory method such as GCMS 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 chromations chemic ടpectrometry (GCMS) 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. The Randox Ecstasy Calibrator Set consists of liquid calibrators containing MDMD. There are 5 levels of calibrator. They have been developed for use in the calibration of Ecstasy assays on the J X day to na" and Amela" analysers. This in vitro diagnostic device in the daily as a line a for prescription use only. The Randox Ecstasy Controls, level 1 and 2 are liquid controls containing MDMA. There are 2 levels of controls. They have been developed for use in the quality control of the Ecstasy assay on the a X day to na" and annual analysers. This in quality control of the ebstay of the only.

Device Story

The Randox Ecstasy Assay is an in vitro diagnostic reagent system for detecting MDMA in human urine. It utilizes liquid calibrators and controls to facilitate testing on automated clinical chemistry analyzers. The device operates in qualitative or semi-quantitative modes; the latter assists laboratories in determining specimen dilution for confirmatory testing (e.g., GCMS) and establishing quality control procedures. The assay is intended for professional use in clinical laboratories. Results are preliminary and require confirmation by a more specific chemical method, such as GCMS. Clinical judgment is required for interpreting positive results. The system benefits patients by providing a rapid screening tool for MDMA presence, facilitating subsequent diagnostic or forensic confirmation.

Clinical Evidence

No clinical data provided; the submission relies on analytical performance characteristics typical of in vitro diagnostic drug screening assays.

Technological Characteristics

In vitro diagnostic reagent system; liquid-based calibrators and controls containing MDMA; designed for use on automated clinical chemistry analyzers; qualitative or semi-quantitative detection mode; 500ng/mL cutoff concentration.

Indications for Use

Indicated for the qualitative or semi-quantitative detection of MDMA in human urine at a 500ng/mL cutoff. Intended for prescription use in clinical laboratory settings to provide preliminary analytical results requiring confirmation by GCMS.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine 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

Public Health Service

Randox Laboratories, Ltd c/o Dr. Pauline Armstrong Regulatory Affairs 55 Diamond RD. Crumlin, County Antrim United Kingdom BT29 4QY Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

MAR 0 1 2011

Re: k092275

Trade Name: Randox Ecstasy (MDMA) Assay Regulation Number: 21 CFR 862.3650 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Codes: DKZ, DLJ, LAS Dated: February 22, 2011 Received: February 24, 2011

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney C. Harper, Ph.D.

Courtney Q. Harper, Ph.D. 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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# Indication for Use

510(k) Number (if known):

k092275

Device Name:

ECSTASY ASSAY, CALIBRATOR SET AND CONTROLS LEVEL 1 & 2

".

. . .

Indication For Use:

#### Randox Ecstasy Assay

The Randox Laboratories Ltd. Ecstasy Assay is an in vitro diagnostic test for the detection of MDMA in human urine with a cut off concentration of 500ng/ml, for use on the Unean of the uneath of Mondal analysers in qualitative or semi-quantititive mode. The assay is calibrated against MDMA. 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 difution of the specimen for confirmation by a
confirmatory method such as GCMS 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 chromations chemic ടpectrometry (GCMS) 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 Ecstasy Calibrator Set

The Randox Ecstasy Calibrator Set consists of liquid calibrators containing MDMD. There are 5 levels of calibrator. They have been developed for use in the calibration of Ecstasy assays on the J X day to na" and Amela" analysers. This in vitro diagnostic device in the daily as a line a for prescription use only.

## Randox Ecstasy Controls, Level 1 & 2

The Randox Ecstasy Controls, level 1 and 2 are liquid controls containing MDMA. There are 2 levels of controls. They have been developed for use in the quality control of the Ecstasy assay on the a X day to na" and annual analysers. This in quality control of the ebstay of the 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) K092275