MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062

K033566 · Rapid Diagnostics, Inc. · DKZ · May 17, 2004 · Clinical Toxicology

Device Facts

• Record ID: K033566
• Device Name: MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062
• Applicant: Rapid Diagnostics, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: May 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in-vitro test intended for the qualitative determination of up to nine different drug substances in human urine at the following cut-off levels (amphetamine, 1000 ng/ml; barbiturate [secobarbital], 300 ng/ml; benzodiazepine [oxazepam], 300 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 2000 ng/ml; phencyclidine, 25 ng/ml; and cannabinoid, 50 ng/ml). The MICROMEDIC® Drugs of Abuse Panel Test is intended for use in a point-ofcare (POC) setting to include emergency hospitals and medical care facilities (i.e., emergency rooms, ambulances, etc.), as well as the workplace, criminal justice and transportation arenas, and walk-in, or mobile drug testing facilities. The MICROMEDIC® Drugs of Abuse Panel Test will provide a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. It is the responsibility of those organizations required to follow Department of Transportation (DOT) or the Substance Abuse and Mental Health Administration (SAMHSA) Workplace Drug Testing Guidelines to determine that use of this product satisfics the criteria for workplace testing established under DOT and SAMHSA.

Device Story

Single-use dip-and-read test card; lateral flow immunochromatographic assay. Input: human urine sample. Principle: competitive binding between drug in sample and drug conjugate for limited antibody-dye conjugate. Output: visual colored bands on test strip; absence of band at test line indicates positive result; presence of band at control line indicates valid test. Used in point-of-care settings (hospitals, workplace, criminal justice) by POC staff. Provides preliminary analytical results; requires GC/MS confirmation for clinical decision-making. Benefits: rapid, on-site screening for drug presence.

Clinical Evidence

No clinical studies performed. Performance evaluated via analytical bench testing (precision/reproducibility) and method comparison studies. Precision study used spiked urine controls across three POC sites. Method comparison evaluated accuracy against GC/MS using naturalistic and spiked samples; results demonstrated agreement with original in-house performance data.

Technological Characteristics

Lateral flow immunochromatographic assay. Components: mouse monoclonal anti-drug antibody, goat anti-mouse IgG control line. Form factor: single-use dip-and-read test card. Qualitative visual readout. No instrumentation required. No specific materials or standards referenced.

Indications for Use

Indicated for qualitative detection of amphetamine, barbiturates, benzodiazepines, cocaine, methadone, methamphetamine, opiates, phencyclidine, and cannabinoids in human urine at specified cut-off levels. Intended for point-of-care use in emergency medical facilities, workplace, criminal justice, and transportation settings. Prescription use only.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 7 2004

Ms. Robin J. Helen, MS Rapid Diagnostics, Inc. c/o Hellen Professional Services 9418 Lasaine Avenue Northridge, CA 91325

Re: k033566

Trade/Device Name: MICROMEDIC® Drugs of Abuse Panel Test Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DIS, JXM, LDJ, DIO, DJR, DJC,DJG, and LCM Dated: March 19, 2004 Received: March 24, 2004

Dear Ms. Hellen:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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.

Yean 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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## STATEMENT FOR INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

MICROMEDIC® Drugs of Abuse Panel Test

The MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in-vitro test intended for the qualitative determination of up to nine different drug substances in human urine at the following cut-off levels (amphetamine, 1000 ng/ml; barbiturate [secobarbital], 300 ng/ml; benzodiazepine [oxazepam], 300 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 2000 ng/ml; phencyclidine, 25 ng/ml; and cannabinoid, 50 ng/ml).

The MICROMEDIC® Drugs of Abuse Panel Test is intended for use in a point-ofcare (POC) setting to include emergency hospitals and medical care facilities (i.e., emergency rooms, ambulances, etc.), as well as the workplace, criminal justice and transportation arenas, and walk-in, or mobile drug testing facilities. The MICROMEDIC® Drugs of Abuse Panel Test will provide a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. It is the responsibility of those organizations required to follow Department of Transportation (DOT) or the Substance Abuse and Mental Health Administration (SAMHSA) Workplace Drug Testing Guidelines to determine that use of this product satisfics the criteria for workplace testing established under DOT and SAMHSA.

Concurrence of the CDRH, Office of Device Evaluation (ODE)

Alberto Lu
Division Sign-Off

Division Sign-off

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Office of In Vitro Diagnostics Counter Use: Device Evaluation and Safety

510(k) K033566