ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST

K011962 · Advantage Diagnostics Corp. · DIO · Aug 9, 2001 · Clinical Toxicology

Device Facts

• Record ID: K011962
• Device Name: ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST
• Applicant: Advantage Diagnostics Corp.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Aug 9, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Indications for Use

The Advantage Marijuana (THC) and Cocaine Home Drug Test is a qualitative, one step, immunochromatographic assay used to screen human urine for the presence of cannabinoids (THC) at a cut off concentration of 50ng/mL and benzoylecgonine at a cut off of 300ng/mL. The test is the first part of a two-step process to provide consumers with information regarding the presence or absence of THC and/or Cocaine in a urine sample. Confirmation, using GC/MS, of any possible drug result is recommended as the second step.

Device Story

Immunochromatographic lateral flow assay; detects THC and cocaine metabolites in human urine. Device used at home by consumers; provides qualitative screening results. Input: urine sample; Output: visual presence/absence of drug markers. First step in two-step process; positive results require laboratory GC/MS confirmation. Benefits patient by providing preliminary drug presence information.

Technological Characteristics

Immunochromatographic lateral flow assay; qualitative detection; urine specimen; cut-off levels 50ng/mL (THC) and 300ng/mL (cocaine metabolites).

Indications for Use

Indicated for home use by consumers to qualitatively screen human urine for THC (cannabinoids) at 50ng/mL and cocaine metabolites (benzoylecgonine) at 300ng/mL. Recommended for use as a preliminary screening tool requiring GC/MS confirmation for positive results.

Regulatory Classification

Identification

A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Special Controls

*Classification.* Class II (special controls). A cocaine and cocaine metabolite 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).

Predicate Devices

• Phamatec QuickScreen™ At Home Test

Submission Summary (Full Text)

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K011962

## 510(k) Summary

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92.

The assigned 510(k) number is:

1. Date of summary: June 11, 2001

- Advantage Diagnostics Corporation 2. Submitted by: 1201 Douglas Ave Redwood City CA 94063
Advantage Marijuana (THC) and Cocaine Home Drug Test 3. Device Name:

4. Device Classification: Class II, Panel 91 Toxicology

5. Device description: The Advantage Marijuana (THC) and Cocaine Home Drug Test is an immunochromatographic based one step in vitro test for use at home.

6. Intended Use: The Advantage Marijuana (THC) Home Drug Test is designed for the qualitative determination of THC (cannabinoids) in human urine at a cut off level of 50ng/mL and Cocaine metabolites at a cut off of 300ng/mL.

The test is the first part of a two-step process to provide consumers with information regarding the presence or absence, of THC and /or Cocaine in a urine sample. Confirmation, using GC/MS, of any possible drug result is recommended as the second step.

7. Substantial Equivalence: The Advantage Marijuana (THC) and Cocaine Home Drug Test is substantially equivalent to several other professional and over the counter immunoassay Drugs of Abuse Tests, such as Phamatec QuickScreen™ At Home Test. Both home drug tests are the first of a two-step process to detect the presence or absence of drugs of abuse in human urine and require consumers to confirm possible positive results with GC/MS.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 9 2001

Ms. Janis Freestone Director, Regulatory Affairs Advantage Diagnostics Corporation, Ltd. 4 Holyrood Street Chard, Somerset UK TA20 2AH

510(k) Number: K011962 Re: Trade/Device Name: Advantage Marijuana (THC) and Cocaine Home Drug Test Regulation Number: 862.3250, 862.3870 Regulatory Class: II Product Code: DIO, LDJ Dated: June 20, 2001 Received: June 22, 2001

Dear Ms. Freestone:

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 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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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 v 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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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KO11962 510k Number:

Device Name: Device Name.
Advantage Marijuana (THC) and Cocaine Home Drug Test

Indications for Use:

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Aan Cooper
Division Sign-Off

ivision of Clinical Laboratory Devices 510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109) OR

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