AT HOME DRUG TEST, MODEL 9079

K013408 · Phamatech, Inc. · DJG · Dec 6, 2001 · Clinical Toxicology

Device Facts

• Record ID: K013408
• Device Name: AT HOME DRUG TEST, MODEL 9079
• Applicant: Phamatech, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Dec 6, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

The At Home Drug Screening Test is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for this test is as follows: THC; 50 ng/ml. This assay is intended for use in the home to assist in preventing drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a SAMHSA certified laboratory.

Device Story

At Home Drug Test (Model 9079) is a lateral flow immunoassay for qualitative detection of THC in urine. Device utilizes immunochemical sandwich assay principle; specific antibodies bind to target drug/metabolites in urine sample; results visualized via color change on test strip. Intended for home use by lay users to assist in preventing drug abuse. Kit includes mechanism for anonymous confirmation testing at SAMHSA-certified laboratory. Healthcare providers or users interpret visual results to determine presence of drug. Provides preliminary screening; positive results require confirmation via laboratory analysis.

Clinical Evidence

Bench testing included precision studies and blind labeled spiked studies. Correlation studies using clinical specimens showed >99% correlation with Behring EMIT II and GC/MS methodology. Clinical studies at two independent laboratories demonstrated >98% overall accuracy in professional hands. Consumer study showed 97% accuracy (915/943) in user interpretation.

Technological Characteristics

Lateral flow immunoassay; qualitative visual colorimetric readout. Principle: immunochemical sandwich assay (antibody/target drug/antibody complex). Analyte: THC in urine (50 ng/ml cut-off). Standalone, non-electronic, single-use test kit.

Indications for Use

Indicated for home use to provide preliminary qualitative detection of THC (marijuana) in urine at a 50 ng/ml cut-off concentration. Includes mechanism for anonymous confirmation testing at a SAMHSA certified laboratory.

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).

Predicate Devices

• Control Biotech SureStep Test

Reference Devices

• Behring EMIT II

Submission Summary (Full Text)

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DEC 0 6 2001

K013408

## 510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)

Identification: At Home Drug Test (Model 9079)

Description: Immunoassay for the qualitative detection of THC in urine.

Name Of Manufacturer:

Phamatech 9530 Padgett Street, Suite #101 San Diego, California 92126, USA

Intended Use: The At Home Drug Screening Test is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for this test is as follows: THC; 50 ng/ml. This assay is intended for use in the home to assist in preventing drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a SAMHSA certified laboratory.

The At Home Drug Test, like many commercially available drug screening test Technology: kits, qualitatively measures the presence of target drug and metabolites by visual color kils, qualitatively meddato the proches of such predicate devices include the Sandwich one Step Innunodour Control Biotech SureStep Test (San Diego, CA 92121). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug / antibody / complexes.

The product performance characteristics of the At Home Drug Test were Performance: r onomance. - The procession study and a blind labeled spiked study. The results of these studies demonstrate the Phamatech at Home Drug Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative the reported be nematter et drugs in urine. Correlation studies, using clinical specimens, produced a >99% correlation when compared to the Behring EMIT II (Cupertino, CA 95014) and GC/MS methodology. Clinical studies, performed at two independent laboratories, were also performed. In them the Phamatech At Home Drug Test exhibited excellent overall accuracy (>98%) in the hands of professional users. A consumer study was also performed, in it the At Home Drug Test exhibited excellent overall accuracy. Consumer interpretation of the cocaine test showed accuracy to be 915/943 or 97%

For the reasons mentioned above, it may be concluded that the Phamatech At Conclusion: Home Drug Test is substantially equivalent to a variety of detection tests currently in commercial distribution and is safe in the hands of the lay user.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 0 6 2001

Mr. Carl Mongiovi Vice President Phamatech, Inc. 9530 Padgett Street, Suite 101 San Diego, CA 92126

k013408 Re:

Trade/Device Name: At Home Drug Test (Model 9079) Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid Test System Regulatory Class: Class II Product Code: MVO Dated: November 15, 2001 Received: November 19, 2001

Dear Mr. Mongiovi:

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 10 more career 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 r ou may a croy is or ovisions 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 (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 r lease be action and 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 nothication. The I Dri Intellig of baction 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 1 IT you desire spoonne arriver diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in Trive angliestions on the promotion and advertising of your device, [phone]. Traditionally, 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 Information on your responsionals and Consumer 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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## INDICATIONS FOR USE

Applicant: Phamatech

510 (k) Number (if known):

Device Name: At Home Drug Test (Model 9079)

Indications for Use:

A home drug screening, and if needed, confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: THC (marijuana).

Shoven C. Futa for Jean Cooper

(Division Sign-Off Division of Clinical Laboratory Levices 6014409 510(k) Number

PLEASE DO NOT WRITE BELOW THIS LINE

Concurrence of the CDRH Office of Device Evaluation (ODE)

Division Sign-off Division of Clinical Laboratory Devices 510 (k) Number:

Prescription Use: Per 21 CFR 801.109 OR

Over the Counter: X