RANDOX AMPHETAMINE CLASS ASSAY

K040350 · Randox Laboratories, Ltd. · DKZ · May 12, 2004 · Clinical Toxicology

Device Facts

• Record ID: K040350
• Device Name: RANDOX AMPHETAMINE CLASS ASSAY
• Applicant: Randox Laboratories, Ltd.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: May 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The evidence® Amphetamine assays is an in vitro diagnostic test for the qualitative determination of Amphetamine Class of compounds (including amphetamines and methamphetamine), central nervous system stimulating drugs, in human urine. This is a competitive immunoassay. A primary cut-off of 1000 ng/ml has been established in accordance with SAMHSA recommendations. The evidence® Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine and methamphetamine. There are 9 levels of calibrator. They have been developed for use in calibration of the evidence® system. This assay is for use only on the automated evidence® Analyzer. Note: This test provides only a preliminary analytical result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrophotometry (GC/MS) is the preferred confirmatory method. The Amphetamine Class Assay and Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Device Story

The evidence® Amphetamine Assay is an in vitro diagnostic test for use on the evidence® analyzer. It detects amphetamine compounds in urine samples at a 1000ng/ml cutoff. The system utilizes liquid calibrators (evidence® Drugs of Abuse Calibrators) to standardize the assay. Operated by qualified laboratory personnel in a clinical laboratory setting, the device provides qualitative results to assist clinicians in diagnosing and treating amphetamine use or overdose. Results are preliminary and require confirmation via GC/MS. The device benefits patients by providing rapid screening for amphetamine exposure.

Clinical Evidence

No clinical studies performed. Bench testing only. Analytical performance validated via precision/reproducibility studies (NCCLS EP5-T2), interference screening (NCCLS EP7-A), and method comparison against GC/MS and predicate (n=1336 samples). Sensitivity and specificity established using SAMHSA-recommended 1000 ng/mL cut-off.

Technological Characteristics

In vitro diagnostic assay for use on the evidence® analyzer. Employs liquid calibrators containing benzoylecgonine, amphetamine, and methamphetamine (9 levels). Qualitative detection method based on 1000ng/ml cutoff. Designed for professional laboratory use.

Indications for Use

Indicated for qualitative determination of amphetamine and methamphetamine in human urine to aid in diagnosis and treatment of amphetamine use or overdose. For use by qualified laboratory personnel. Preliminary result only; requires GC/MS confirmation.

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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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 symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 2 2004

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

k040350 Rc:

Trade/Device Name: evidence® Amphetamine Assay and the evidence® Drugs of Abuse Calibrators Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, LAF, DKB Dated: January 30, 2004 Received: February 12, 2004

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 interstatc 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, thereforc, 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 docs 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

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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.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, US, DVM.

Jean M. Cooper, MS, D.V.M. 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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# Indications for Use

510(k) Number (if known)_ K040350

## Device Name: evidence® Amphetamine Assay and the evidence® Drugs of Abuse Calibrators

Indications For Use:

#### evidence® Amphetamine Assay

The evidence® Amphetamine assays have been designed for use only on the evidence® analyser for qualitative detection of the amphetamine class of compounds in urine using a cut off concentration of 1000ng/ml in accordance with SAMHSA recommendations. Qualitative results obtained can be utilized in the diagnosis and treatment of amphetamine use or overdose.

## This assay provides only a preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS.

The evidence® Amphetamine assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

### evidence® Drugs of Abuse Calibrators.

The evidence® Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine and methamphetamine. There are 9 levels of calibrator. They have been developed for use in calibration of the evidence® system. The evidence® Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personne! under appropriate laboratory conditions.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Alberto Latz
Division Sign-Off

Office of In Vitro Diag

510(k) K040350

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