RANDOX BARITURATES ASSAY

K092268 · Randox Laboratories, Ltd. · DIS · May 25, 2011 · Clinical Toxicology

Device Facts

• Record ID: K092268
• Device Name: RANDOX BARITURATES ASSAY
• Applicant: Randox Laboratories, Ltd.
• Product Code: DIS · Clinical Toxicology
• Decision Date: May 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3150
• Device Class: Class 2

Intended Use

Randox Barbiturates Assay: The Randox Laboratories Ltd. Barbiturates Assay is an in vitro diagnostic test for the detection of Barbiturates, in human urine on the Rx Imola and Rx Daytona. The cutoff for secobarbital is 200 ng/mL. This in vitro diagnostic device is intended for prescription use only. The semi-quantitative mode 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 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. Randox Multidrug Calibrator Set: Randox Multidrug Calibrator Set consists of liquid calibrators containing Secobarbital, Oxazepam and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Barbiturates, Benzodiazepines and Methadone assays for use on the Rx 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 and 2: Randox Multidrug Controls, Level 1 & 2 are liquid controls containing Secobarbital, Oxazepam and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Barbiturates, Benzodiazepines and Methadone assays for use on the Rx analysers, which includes the Rx-Daytona™ and the Rx-Imola. This in vitro diagnostic device is intended for prescription use only.

Device Story

Randox Barbiturates Assay is an in vitro diagnostic test for human urine; detects barbiturates qualitatively and semi-quantitatively. Operates on Rx Imola and Rx Daytona analyzers. Input: human urine samples. Principle: immunoassay-based detection with 200 ng/mL secobarbital cutoff. Output: preliminary analytical result used by laboratory professionals to determine specimen dilution for confirmatory testing (e.g., GC/MS) or to establish quality control. Device includes liquid calibrators and controls containing Secobarbital, Oxazepam, and Methadone. Used in clinical laboratories; results require professional judgment and clinical correlation. Benefits: provides rapid preliminary screening for barbiturate presence to guide further diagnostic or forensic confirmation.

Clinical Evidence

No clinical trials performed. Analytical performance validated via bench testing. Precision evaluated over 20 days (n=80 per concentration) showing consistent qualitative/semi-quantitative results. Method comparison against GC/MS performed on clinical urine samples; cross-reactivity profiles established for various barbiturates. Interference testing confirmed no significant impact from endogenous compounds or common OTC/prescription drugs.

Technological Characteristics

In vitro diagnostic immunoassay; liquid-based reagents, calibrators, and controls. Designed for use on automated clinical chemistry analyzers (Rx Imola, Rx Daytona). Qualitative and semi-quantitative detection modes. Cutoff concentration: 200 ng/mL secobarbital.

Indications for Use

Indicated for the detection of barbiturates in human urine for prescription use. Intended for use on Rx Imola and Rx Daytona analyzers. Not for therapeutic drug management or quantification of barbiturates in patient samples.

Regulatory Classification

Identification

A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A barbiturate 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized wings.

Public Health Service

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

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

MAY 2 5 2011

Re: k092268

> Trade Name: Randox Barbiturates Assay, Randox Multidrug Calibrator Set, Randox Multidrug Controls Regulation Number: 21 CFR 862.3200 Regulation Name: Barbiturate Test System. Regulatory Class: Class II Product Codes: DIS, DLJ, LAS Dated: May 23, 2011 Received: May 25, 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (27 CFN 7 and 5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 tolli-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

C.C.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Enclosure

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# Indication for Use

510(k) Number (if known):

K092268

Device Name:

BARBITURATES ASSAY AND THE MULTIDRUG CALIBRATOR/CONTROL SET

Indication For Use:

#### Randox Barbiturates Assay

The Randox Laboratorles Ltd. barbiturates Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of barbiturates in human urine on the Rx Imola and Rx Daytona. The cutoff for secobarbital is 200 ng/mL. This in vitro diagnostic device Is intended for prescription use only.

The semi-quantitative mode 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) permilting 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.

#### Randox Multidrug Calibrator Set

The Randox Multidrug Calibrator Set consists of liquid calibrators containing Secobarbital, Oxazepam and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Barbiturates, Benzodiazepines and Methadone assays for use on the JSC and analysers, which includes the a y to na" and the moss™. 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 Secobarbital, Oxazepam and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Barbiturates, Benzodiazepines and Methadone assays for use on the I Kommanalysers, which includes the X day to na™ and the Anmone™. 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)

(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) K092268

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