PROFILE-II MODEL 600582

K982211 · Medtox Diagnostics, Inc. · DKE · Jul 29, 1998 · Clinical Toxicology

Device Facts

• Record ID: K982211
• Device Name: PROFILE-II MODEL 600582
• Applicant: Medtox Diagnostics, Inc.
• Product Code: DKE · Clinical Toxicology
• Decision Date: Jul 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

PROFILE-II is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids (THC), cocaine, opiates, amphetamines and phencyclidine (PCP) in human urine. The test detects the major metabolites of these drugs at the following cut-off concentrations: THC (Tetrahydrocannabinol) 50 ng/mL; COC (Cocaine/Benzoylecgonine) 300 ng/mL; OPS (Opiates/Codeine/Morphine) 300 ng/mL; AMP (Amphetamine) 1000 ng/mL; PCP (Phencyclidine) 25 ng/mL. This product is intended for use under medical supervision in hospitals, physician offices, health clinics and drug treatment/counseling centers. It is not for over-the-counter sale. PROFILE-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, particularly when preliminary positive results are used.

Device Story

PROFILE-II is a one-step immunochromatographic assay for qualitative drug screening in human urine. The device detects metabolites of THC, cocaine, opiates, amphetamines, and PCP at specified cut-off concentrations. Used in clinical settings (hospitals, clinics, drug treatment centers) under medical supervision. The test provides preliminary analytical results; positive results require confirmation via a more specific method, such as GC/MS. Healthcare providers use these preliminary results in conjunction with clinical judgment to inform patient management decisions.

Clinical Evidence

No clinical data provided; device is an in vitro diagnostic test relying on analytical performance characteristics.

Technological Characteristics

Immunochromatographic assay (lateral flow). Qualitative detection of drug metabolites in urine. Standalone test device.

Indications for Use

Indicated for the rapid, qualitative detection of cannabinoids (THC), cocaine, opiates, amphetamines, and phencyclidine (PCP) in human urine. Intended for use under medical supervision in clinical settings (hospitals, physician offices, clinics, drug treatment centers). Not for OTC use.

Regulatory Classification

Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Special Controls

*Classification.* Class II (special controls). A cannabinoid 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/2 description: The image shows the logo for the Department of Health & Human Services - USA. 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 that resembles an eagle or bird in flight, composed of three curved lines.

JUL 29 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Michael Turanchik Director, Research & Development MedTox Diagnostics 1238 Anthony Road Burlington, North Carolina 27215

Re : K982211 PROFILE® -II Regulatory Class: II Product Code: DKE, DIO, DJG, DKZ, LCM Dated: June 22, 1998 Received: June 23, 1998

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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 Requlations, Title 21, Parts 800 to 895. ਰੇ 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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.

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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/dsmamain.html".

Sincerely yours,
Steven Gutman

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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EXHIBIT III PROFILE-II 510(k) SUBMISSION

## INDICATIONS FOR USE FORM

510(k) Number (if known): Jurg 22 l (

Device Name: __ PROFILE-II

Indications for Use:

PROFILE-II is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids (THC), cocaine, opiates, amphetamines and phencyclidine (PCP) in human urine. The test detects the major metabolites of these drugs at the following cut-off concentrations:

| THC | Tetrahydrocannabinol | 50 ng/mL |
|-----|----------------------------|------------|
| COC | Cocaine (Benzoylecgonine) | 300 ng/mL |
| OPS | Opiates (Codeine/Morphine) | 300 ng/mL |
| AMP | Amphetamine | 1000 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |

This product is intended for use under medical supervision in hospitals, physician offices, health clinics and drug treatment/counseling centers. It is not for over-the-counter sale.

PROFILE-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, particularly when preliminary positive results are used.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | or Over-The-Counter Use |
|------------------------------------------|-------------------------|
|------------------------------------------|-------------------------|

(Division Sign-Off)
Division of Clinical Laboratory Device:

| 510(k) Number | |
|---------------|--|
| 7 | |