RANDOX OPIATES ASSAY

K113747 · Randox Laboratories Limited · DJG · Aug 24, 2012 · Clinical Toxicology

Device Facts

• Record ID: K113747
• Device Name: RANDOX OPIATES ASSAY
• Applicant: Randox Laboratories Limited
• Product Code: DJG · Clinical Toxicology
• Decision Date: Aug 24, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

Randox Opiates Assay: The Randox Laboratories Ltd. Opiates Assay is an in vitro diagnostic test for the qualitative and semi-quantitative analysis of Opiates in human urine. The cut off for both the qualitative and semi-quantitative application is 2000ng/ml for morphine to which the assay is calibrated. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of Opiate use or overdose. The Randox Opiates Assay has been developed for use on the RX series analysers, which includes the RX Daytona and the 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 GCMS, or (2) Permitting laboratories to establish quality control procedures. This assay provides only a preliminary analytical test 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. Randox Multidrug Calibrator Set: The Randox Multidrug Calibrator Set is for use on human urine samples. They are liquid calibrators containing Methamphetamine, Secobarbital, Methadone, and Morphine. There are 5 levels of calibrator. They have been developed for use in the calibration of Amphetamine, Barbiturates, Methadone and Opiate assays on the RX series analysers, which includes the RX Daytona and RX Imola. 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 for use on human urine samples. They are liquid controls containing Methamphetamine, Secobarbital, Methadone, and Morphine. There are 2 levels of controls. They have been developed for use in the quality control of quality control of Amphetamine, Barbiturates, Methadone and Opiate assays on the RX series analysers, which includes the RX Daytona and RX Imola. This in vitro diagnostic device is intended for prescription use only.

Device Story

The Randox Opiates Assay is an in vitro diagnostic test for human urine; utilizes RX series analyzers (RX Daytona, RX Imola) for qualitative and semi-quantitative detection of opiates at a 2000ng/ml cutoff. The system includes liquid calibrators and controls containing Methamphetamine, Secobarbital, Methadone, and Morphine. The assay provides preliminary results; requires confirmation via GC/MS. Used by laboratory professionals to assist in diagnosing opiate use or overdose and to determine specimen dilution for confirmatory testing. Benefits include rapid preliminary screening to guide clinical decision-making and laboratory quality control.

Clinical Evidence

Bench testing only. Evaluated precision over 20 days (intra- and inter-assay) using spiked urine samples. Linearity/recovery assessed via serial dilutions. Analytical specificity tested against structurally related and unrelated compounds per CLSI EP7-A2. Method comparison performed on 128 clinical urine samples against GC/MS; results showed high agreement for both qualitative and semi-quantitative modes on RX Daytona and RX Imola analyzers.

Technological Characteristics

Liquid, ready-to-use two-reagent system. Principle: Competitive enzyme immunoassay (G6PDH). Energy source: Spectrophotometric measurement at 340nm. Materials: Mouse monoclonal anti-morphine antibodies, morphine-labeled G6PDH, NAD, sodium azide (<0.1%). Analyzers: RX Daytona and RX Imola. Standards: CLSI EP7-A2 (interference), EP17-A (LoD/LoQ).

Indications for Use

Indicated for the qualitative and semi-quantitative analysis of Opiates in human urine to aid in the diagnosis and treatment of Opiate use or overdose. Intended for prescription use in clinical laboratory settings using RX series analyzers (RX Daytona, RX Imola).

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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that form the shape of the bird's body and wings. The text is in a simple, sans-serif font and is evenly spaced around the circle.

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

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

k113747 Re:

Trade Name: Randox Opiates Assay Randox Multidrug Calibrator Set Randox Multidrug Controls, Level 1 and Level 2 Regulation Number: 21 CFR § 862.3650 Regulation Name: Opiate test system

Regulatory Class: Class II Product Codes: DJG, DLJ, LAS Dated: July 5, 2012 Received: July 13, 2012

## Dear Dr Armstrong:

We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Sector 310(x) pecimatice is substantially equivalent (for the referenced above and have detemmed the device is succedicate devices marketed in
indications for use stated in the enclosure) to legally marketed in
the enclose of use stated indications for use stated in the enclosure) to regality mannel date of the Medical Device in interstate commerce prior to May 25, 1976, the enactive with the provisions of
Amendments, or to devices that have been recurse approval of a premarks Amendments, or to devices that have been recurse worker approval of a premaikst
the Federal Food, Drug, and Cosmetic Act (Act ) that do not require approval of a premailse the Federal Food, Drug, and Cosmetic Act (Act) that do horio sports of the general
approval application (PMA). You may, therefore, market the device, subject to the general approval application (PMA). The general controls provisions of the Act include controls provisions of the Act. Lie general controls provides, good manufacturing practice,
requirements for annual registration, listing of devices, good manufacturing requirements for annual registration, noming and adulteration.
Iabeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III)
Controls (see and collicion) control litianal controls. Existing major regulat If your device is classified (see above) into elife) in (Openar or regulations affecting
(PMA), it may be subject to such additional controls. Existings (CFR), Parts 800 to (PMA), it may be subject to such additions: Existing institutions (CFR), Parts 800 to 895.
your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 your device can be found in Title 21, Code of Federal Negallatons (Cris)
In addition, FDA may publish further announcements concerning your device in the Escient Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not
he months and and to mination that your device complies with other requirement Please be advised that FDA's issuance of a substance complies with other requirement's
mean that FDA has made a determination that your device with other requires. mean that FDA his made a determination into continues and processor in the Federal agencies.
of the Act or any Federal des and regulations administered by not limited to: reg of the Act or any Federal stantes and regulations administered by out not limited to: registration
You must comply with all the Act's requirements, including, but not limited You must comply with all the Act S requirements, including of the more
and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and go and listing (21 CFR Part 807); labeling (21 CFR rats 803 mln.) (21 CFR 803); and good
reporting (reporting of medical device-related adverse events) (21 CFR 803); regulation reporting (reporting of medical device-related adverse evenis) (21 UN 000), and go
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

AUG 2 4 2012

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific ad view 10. Jour es . Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 proase note the regulation villance, "Milion news arrestlance, please contact CDRB is Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) Office of Surveinance and Droinears of (SD) of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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 Tou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.html

Sincerely yours,

V

Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices 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): k113747

## Device Name: OPIATES ASSAY AND THE RANDOX MULTIDRUG CALIBRATOR SET AND MULTIDRUG CONTROLS LEVEL 1 & LEVEL 2

Indication For Use:

Randox Opiates Assay: The Randox Laboratories Ltd. Opiates Assay is an in vitro diagnostic test for the qualitative and semi-quantitative analysis of Opiates in human urine. The cut off for both the qualitative and semi-quantitative application is 2000ng/ml for morphine to which the assay is calibrated. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of Opiate use or overdose. The Randox Opiates Assay has been developed for use on the RX series analysers, which includes the RX Daytona and the 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 GCMS, or (2) Permitting laboratories to establish quality control procedures.

This assay provides only a preliminary analytical test 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.

Randox Multidrug Calibrator Set: The Randox Multidrug Calibrator Set is for use on human urine samples. They are liquid calibrators containing Methamphetamine, Secobarbital, Methadone, and Morphine. There are 5 levels of calibrator. They have been developed for use in the calibration of Amphetamine, Barbiturates, Methadone and Opiate assays on the RX series analysers, which includes the RX Daytona and RX Imola. 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 for use on human urine samples. They are liquid controls containing Methamphetamine, Secobarbital, Methadone, and Morphine. There are 2 levels of controls. They have been developed for use in the quality control of Amphetamine, Barbiturates, Methadone and Opiate assays on the RX series analysers, which includes the RX Daytona and RX Imola. This in vitro diagnostic device is intended for prescription use only.

Prescription Use マ (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)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) < 113742