RANDOX COCAINE METABOLITE

K113751 · Randox Laboratories, Ltd. · DIO · May 8, 2012 · Clinical Toxicology

Device Facts

• Record ID: K113751
• Device Name: RANDOX COCAINE METABOLITE
• Applicant: Randox Laboratories, Ltd.
• Product Code: DIO · Clinical Toxicology
• Decision Date: May 8, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Intended Use

The Randox Laboratories Ltd. Cocaine Metabolite Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of Cocaine in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300 ng/ml for benzoylecgonine. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of Cocaine use or overdose. The Randox Cocaine Metabolite 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 modes is for purpose 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 result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ 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 Cocaine Metabolite Assay, Multidrug Calibrator Set, and Multidrug Controls are in vitro diagnostic reagents for use on RX series analyzers (RX Daytona, RX Imola). Assay detects Benzoylecgonine in human urine; provides qualitative/semi-quantitative results. Calibrators and controls contain Methamphetamine, Secobarbital, Oxazepam, Benzoylecgonine, and Methadone. Used in clinical laboratory settings by trained personnel. Semi-quantitative mode assists in determining specimen dilution for GC/MS confirmation and establishing quality control. Results are preliminary; clinical judgment required for interpretation. Benefits include rapid screening for Cocaine use/overdose in clinical settings.

Clinical Evidence

No clinical studies performed. Performance established via bench testing and method comparison against GC/MS. Comparison study of 137 urine samples showed high concordance with GC/MS (97.2%–98.6% agreement). Analytical performance included precision, linearity, and cross-reactivity/interference testing.

Technological Characteristics

Liquid-based reagents, calibrators, and controls. Designed for use on RX series automated clinical chemistry analyzers (RX Daytona, RX Imola). Qualitative and semi-quantitative detection via immunoassay principles. Cutoff concentration: 300ng/ml for Benzoylecgonine.

Indications for Use

Indicated for the qualitative and semiquantitative detection of Cocaine (Benzoylecgonine) in human urine at a 300ng/ml cutoff. Intended for use by clinical laboratories to assist in the diagnosis and treatment of Cocaine use or overdose. Requires prescription use. Not for definitive diagnosis; requires confirmation by GC/MS.

Regulatory Classification

Identification

A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Special Controls

*Classification.* Class II (special controls). A cocaine and cocaine metabolite 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 consists of a stylized depiction of a human figure embracing a bird, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

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

MAY - 8 2012

k113751 Re:

RT13131 Randox' Multidrug Calibrator Set Randox Multidrug Controls, Level 1 & 2 Regulation Number: 21 CFR §862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Codes: DIO, DLJ, and LAS Dated: March 30, 2012 Received: April 02, 2012

Dear Ms. Armstrong:

We have reviewed your Section 510(k) premarket notification of intent to market the device is We nave reviewed your Section 510(x) premier is substantially equivalent (for the referenced above and nave atternment and actived predicated predicated in
indications for use stated in the enclosure to the marketed in indications for use stated in the cheosure/ to regars ment date of the Medical Device interstate commerce prior to May 20, 1970, the sideed in accordance with the provisions of
Amendments, or to devices that have been reclassified in accordance approval of a p Amendments, of to devices that have been router approval of approval of a premarket
the Federal Food, Drug, and Cosmetic Act (Act) that do not require, systems to the general the Federal Food, Drug, and COSIlienc Act (related the device, subject to the general
approval application (PMA). You may, therefore, market the devices subject to the gener approval application (1 MA). Tou may, increased controls provisions of the Act include controls provisions of the Act. The general of any of devices, good manufacturing practice,
requirements for annual registration, listing of devices on lequirements for annual is against misbranding and adulteration.

If your device is classified (see above) into either class III (Special Controls) or class III
ns affective If your device is classified (see above) into chine major regulations affecting
(PMA), it may be subject to such additional controls. Existing (CFR), Parts 800 to 895 (PMA), it may be subject to Such adultional Concern Concerner (CFR), Partis 800 to 895.
your device can be found in Title 21, Code of Federal Regulations (CFR), Partis 800 to your device can be found in Title 21, Code of Peacharts (1 - 1) - )
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 Please be advised that FDA s Issuanter of a stuck complies with other requirements
mean that FDA has made a determination odministared by other Federal agencies. mean that FDA has made a delemination mat your and result was and registration of the Act or any Federal statues and tegulations and limited to: registration
You must comply with all the Act's requirements, including, but not limited to: registration You must comply with all the Act Sicquitently more 801 and 809); medical device
and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and go and listing (21 CFR Part 807); fabeting (21 CFR rans ovents) (21 CFR 803); and good
reporting (reporting of medical device-related adverse events) (21 CFR 803); and good reporting (reporting of medical device-related adverse overse) (22 =========================================================================================================== 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/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 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/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

N

Courtney 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):

#### UNKNOWN

Device Name:

#### COCAINE METABOLITE ASSAY, MULTIDRUG CALIBRATOR SET AND MULTIDRUG CONTROLS LEVEL 1 & 2

#### Indication for Use:

### Randox Cocaine Metabolite Assay

The Randox Laboratories Ltd. Cocaine Assay is an in vitro diagnostic test for the qualitative and semiquantitative detection of Cocaine in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300ng/ml for Benzovlecgonine. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of Cocaine use or overdose. The Randox Cocaine Metabolite 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 result. A more specific alternative chemical 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 consists of liquid calibrators containing Methamphetamine, Secobarbital, Oxazepam, Benzoylecgonine and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Amphetamine, Barbiturates, Cocaine and Methadone assays 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.

# Randox Multidrug Controls, Level 1 & 2

The Randox Multidrug Controls, level 1 and 2 are liquid controls containing Methamphetamine, Secobarbital, Oxazepam, Benzoylecgonine and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Amphetamine, Barbiturates, Cocaine and Methadone assays 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.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

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)

DSA

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k 113 71