MICRO-STRIP FOR MARIJUANA METABOLITES

K991516 · Microdiagnostics, Inc. · LDJ · Aug 5, 1999 · Clinical Toxicology

Device Facts

• Record ID: K991516
• Device Name: MICRO-STRIP FOR MARIJUANA METABOLITES
• Applicant: Microdiagnostics, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Aug 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

The MICRO-STRIP FOR MARIJUANA METABOLITES is an immunoassay that qualitatively detects the major Marijuana metabolites (tetrahydrocannabinoids/THC) in urine at the SAMHSA cutoff level of 50 ng/m1. The MICRO-STRIP FOR MARIJUANA METABOLITES is Intended for use by clinical toxicology laboratories, physician offices, drug abuse clinics and law enforcement agencies only.

Device Story

Micro-Strip for Marijuana Metabolites is a lateral flow immunoassay for qualitative detection of THC metabolites in urine. Device utilizes competitive binding principle; urine sample applied to test strip; presence of THC metabolites inhibits binding of labeled antibody to immobilized antigen; visual color change indicates presence or absence of drug at 50 ng/mL cutoff. Used in clinical toxicology labs, physician offices, drug abuse clinics, and law enforcement settings. Provides rapid, qualitative screening results to assist healthcare providers or authorized personnel in identifying potential marijuana use. Results intended for preliminary screening; positive results typically require confirmation by alternative chemical methods.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing and performance characteristics typical of immunoassay screening devices.

Technological Characteristics

Lateral flow immunoassay; qualitative visual readout; detects THC metabolites at 50 ng/mL cutoff; manual test strip format; non-automated; no electronic components or software.

Indications for Use

Indicated for qualitative detection of major marijuana metabolites (THC) in human urine at a 50 ng/mL cutoff level. Intended for use by clinical toxicology laboratories, physician offices, drug abuse clinics, and law enforcement agencies.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 5 1999

Mr. Roy Chung President Microdiagnostics, Inc. 28062 Forbes Road, Suite B Laguna Niguel, California 92677

Re: K991516

> Trade Name: MICRO-STRIP FOR MARIJUANA METABOLITES Regulatory Class: II Product Code: LDJ Dated: July 26, 1999 Received: July 29, 1999

Dear Mr. Chung:

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.

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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/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

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510 (k) NUMBER (IF KNOWN) :

MICRO-STRIP FOR MARIJUANA METABOLITES DEVICE NAME:

INDICATIONS FOR USE:

The MICRO-STRIP FOR MARIJUANA METABOLITES is an immunoassay that qualitatively detects the major Marijuana metabolites (tetrahydrocannabinoids/THC) in urine at the SAMHSA cutoff level of 50 ng/m1. The MICRO-STRIP FOR MARIJUANA METABOLITES is Intended for use by clinical toxicology laboratories, physician offices, drug abuse clinics and law enforcement agencies only.

Leiva Cooper
(Division Sign-Off)

Division of Clinical Laboratory
510(k) Number K991546

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

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

Prescription Use V (Per 21 CFR 801.109) OR

Over - The - Counter - Use (Optional Format 1-2-96)