VERDICT II, PROFILE II

K031032 · Medtox Diagnostics, Inc. · DJG · Jul 14, 2003 · Clinical Toxicology

Device Facts

• Record ID: K031032
• Device Name: VERDICT II, PROFILE II
• Applicant: Medtox Diagnostics, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Jul 14, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

Verdict®-II THC/COC/OPI/MAMP-MDMA is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids, opiates, cocaine, methamphetamine (MAMP), and 3,4-methylenedioxymethylamphetamine (MDMA) and their metabolites. The test detects the major metabolites of these drugs at the following cutoff concentrations: Cannabinoids (11 nor-9-carboxy-Δ 9 -THC)-50 ng/ml Opiates (morphine)-300 ng/ml Cocaine (benzoylecgonine)-300 ng/mL Methamphetamine (MAMP)-1000 ng/mL 3,4-methylenedioxymethlyamphetamine (MDMA)-1500 ng/mL This product is not for over-the-counter-sale Verdict®-II provides only a preliminary analytical test result. A more specific alternate 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 applied to any drug of abuse test result

Device Story

Verdict®-II is a one-step immunochromatographic assay for qualitative detection of drug metabolites in urine. Device utilizes lateral flow technology to detect cannabinoids, opiates, cocaine, methamphetamine, and MDMA at specified cutoff concentrations. Intended for professional use in clinical settings to provide preliminary analytical results. Results require confirmation via alternate chemical methods, preferably GC/MS. Healthcare providers use output to inform clinical judgment regarding potential drug use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

One-step immunochromatographic lateral flow assay. Qualitative detection based on competitive binding principle. Designed for urine specimen analysis. No electronic components, software, or energy sources.

Indications for Use

Indicated for the rapid, qualitative detection of cannabinoids, opiates, cocaine, methamphetamine, and MDMA metabolites in human urine. For professional use only; not for over-the-counter sale. Provides preliminary analytical results requiring confirmation by alternate chemical methods (e.g., GC/MS).

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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure in profile, with three faces overlapping to represent the department's focus on health and well-being. The figure is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 4 2003

Mr. Alan Morris Manager, Product Development Medtox Diagnostics, Inc. 1238 Anthony Road Burlington, NC 27215

Re: k031032 Trade/Device Name: Verdict® -II THC/OPI/COC/MAMP-MDMA Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ; DIO; DJC; DJC: DJG Dated: June 18, 2003 Received: June 19, 2003

Dear Mr. Morris:

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,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Attachment 2 Indications for Use Statement

| 510(k) Number (if known) | K031032 |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Verdict®-II THC/OPI/COC/MAMP-MDMA |
| Indications for Use | Verdict®-II THC/COC/OPI/MAMP-MDMA is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids, opiates, cocaine, methamphetamine (MAMP), and 3,4-methylenedioxymethylamphetamine (MDMA) and their metabolites. The test detects the major metabolites of these drugs at the following cutoff concentrations: |
| | Cannabinoids (11 nor-9-carboxy-Δ ⁹ -THC)-50 ng/ml<br>Opiates (morphine)-300 ng/ml<br>Cocaine (benzoylecgonine)-300 ng/mL<br>Methamphetamine (MAMP)-1000 ng/mL<br>3,4-methylenedioxymethlyamphetamine (MDMA)-1500 ng/mL |
| | This product is not for over-the-counter-sale |
| | Verdict®-II provides only a preliminary analytical test result. A more specific alternate 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 applied to any drug of abuse test result |
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| Prescription Use (Per 21 CFR 801. 109) | <img src="checkmark.png"/> OR Over-The-Counter Use |
| | <img src="signature.png"/><br>Division Sign-Off |
| | Office of In Vitro Diagnostic Device Evaluation and Safety |
| | 34<br>510(k) K031032 |