VERDICT-II

K022141 · Medtox Diagnostics, Inc. · DJC · Jul 30, 2002 · Clinical Toxicology

Device Facts

• Record ID: K022141
• Device Name: VERDICT-II
• Applicant: Medtox Diagnostics, Inc.
• Product Code: DJC · Clinical Toxicology
• Decision Date: Jul 30, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Indications for Use

Verdict®-II Propoxyphene/Methamphetamine-MDMA is a one-step immunochromatographic test for the rapid, qualitative detection of methamphetamine (MAMP), 3,4-methylenedioxymethylamphetamine (MDMA) and their metabolites; propoxyphene, and its main metabolite norpropoxyphene. The test detects the major metabolites of these drugs at the following cutoff concentrations: Methamphetamine (MAMP)-1000 ng/mL 3,4-methylenedioxymethlyamphetamine (MDMA)-1500 ng/mL Norpropoxyphene (Main metabolite of propoxyphene)-300 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 drug screening in urine. Device detects methamphetamine (1000 ng/mL cutoff), MDMA (1500 ng/mL cutoff), and norpropoxyphene (300 ng/mL cutoff). Used in clinical settings by healthcare professionals to provide preliminary analytical results. Results require confirmation via GC/MS or other specific chemical methods. Clinical judgment must be applied to all test results. Device aids in identifying potential drug abuse; does not provide definitive diagnosis.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

One-step immunochromatographic assay. Qualitative lateral flow test format. Detects MAMP, MDMA, and norpropoxyphene metabolites. Cutoff concentrations: 1000 ng/mL (MAMP), 1500 ng/mL (MDMA), 300 ng/mL (norpropoxyphene).

Indications for Use

Indicated for the rapid, qualitative detection of methamphetamine, MDMA, and propoxyphene (and their metabolites) in human urine. Intended 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

A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

Special Controls

*Classification.* Class II (special controls). A methamphetamine 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

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 3 0 2002

Mr. Michael Turanchik Director. Research & Development Medtox Diagnostics, Inc. 1238 Anthony Road Burlington, NC 27215

Re: k022141

> Trade/Device Name: Verdict® -II Propoxyphene/Methamphetamine-MDMA Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: DJC; JXN Dated: July 1, 2002 Received: July 2, 2002

Dear Mr. Turanchik:

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. Iisting 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact.the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsmaldsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment 2 Indications for Use Statement

| 510(k) Number (if known) | K022141 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Verdict®-II Propoxyphene/Methamphetamine-MDMA |
| Indications for Use | Verdict®-II Propoxyphene/Methamphetamine-MDMA is a one-step immunochromatographic test for the rapid, qualitative detection of methamphetamine (MAMP), 3,4-methylenedioxymethylamphetamine (MDMA) and their metabolites; propoxyphene, and its main metabolite norpropoxyphene. The test detects the major metabolites of these drugs at the following cutoff concentrations:<br>Methamphetamine (MAMP)-1000 ng/mL<br>3,4-methylenedioxymethlyamphetamine (MDMA)-1500 ng/mL<br>Norpropoxyphene (Main metabolite of propoxyphene)-300 ng/mL<br>This product is not for over-the-counter-sale<br>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)

OR

Prescription Use
(Per 21 CFR 801. 109)

Over-The-Counter Use

At an Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022141

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