VERDICT -II OPIATES 2000

K992111 · Medtox Diagnostics, Inc. · DJG · Dec 16, 1999 · Clinical Toxicology

Device Facts

• Record ID: K992111
• Device Name: VERDICT -II OPIATES 2000
• Applicant: Medtox Diagnostics, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Dec 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

VERDICT -II OPIATES 2000 is a one-step immunochromatographic test for the rapid, qualitative detection of opiates (morphine and/or codeine) in human urine. The test detects opiates and their major metabolites at the cut-off concentration of 2000ng/mL. It is not for overthe-counter sale. VERDICT®-II OPIATES 2000 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, particularly when preliminary positive results are used.

Device Story

VERDICT-II OPIATES 2000 is a one-step immunochromatographic assay for qualitative detection of opiates in human urine. Device utilizes lateral flow technology to detect morphine and codeine metabolites at 2000ng/mL cutoff. Intended for professional use in clinical settings to provide preliminary screening results. Results require confirmation via alternate chemical methods, preferably GC/MS. Clinical judgment must be applied to all results. Benefits include rapid preliminary screening for drug abuse.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

One-step immunochromatographic assay; lateral flow format; qualitative detection; 2000ng/mL cutoff; urine specimen matrix.

Indications for Use

Indicated for rapid, qualitative detection of opiates (morphine/codeine) in human urine at 2000ng/mL cutoff. For professional use only; not for OTC sale. Requires confirmatory testing (e.g., GC/MS) for positive results.

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)

{0}------------------------------------------------

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the edge. Inside the circle is a stylized symbol that resembles an abstract caduceus, with three lines representing the staff and a single line representing the snake.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 6 1999

Mr. Michael Turanchik Director of Research and Development MedTox Diagnostics, Inc. 1238 Anthony Road Burlington, North Carolina 27215

Re: K992111

Trade Name: VERDICT® -II OPIATES 2000 Regulatory Class: II Product Code: DJG Dated: November 11, 1999 Received: November 15, 1999

Dear Mr. Turanchik:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{1}------------------------------------------------

## Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Sutman

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

{2}------------------------------------------------

## EXHIBIT III - VERDICT-II OPIATES 2000 510(k) Submission

## INDICATIONS FOR USE FORM

510(k) Number (if known): k992111

Device Name: VERDICT®-II OPIATES 2000

Indications for Use:

VERDICT -II OPIATES 2000 is a one-step immunochromatographic test for the rapid, qualitative detection of opiates (morphine and/or codeine) in human urine. The test detects opiates and their major metabolites at the cut-off concentration of 2000ng/mL. It is not for overthe-counter sale.

VERDICT®-II OPIATES 2000 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, particularly when preliminary positive results are used.

per
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992111

.'

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use