AT HOME DRUG CUP, MODEL 9150X

K030447 · Phamatech · MVO · Apr 14, 2003 · TX

Device Facts

• Record ID: K030447
• Device Name: AT HOME DRUG CUP, MODEL 9150X
• Applicant: Phamatech
• Product Code: MVO · TX
• Decision Date: Apr 14, 2003
• Decision: SESE
• Submission Type: Special
• Device Class: Class U

Intended Use

The At Home Drug Cup is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentration for this test is as follows: amphetamine and MDA; 1000 ng/ml, methamphetamine and MDMA; 500 ng/ml, THC (or marijuana); 50 ng/ml, cocaine; 300 ng/ml, opiates; 300 ng/ml. This assay is intended for use in the home to assist in the prevention of 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 Cup (Model 9150X) is a lateral flow, visual color, one-step immunoassay for qualitative detection of drugs of abuse in urine. Input is a urine sample; device uses immunochemical sandwich assay principle where specific antibodies bind to target drug/metabolite complexes to produce a visual color change. Output is a qualitative visual result indicating presence or absence of target drugs at specified cut-off concentrations. Designed for home use by lay individuals; includes mechanism for anonymous confirmation testing at SAMHSA-certified laboratories. Assists users in drug abuse prevention by providing preliminary screening results.

Clinical Evidence

Clinical performance evaluated via clinical sample correlation study and blind labeled spiked study. Correlation studies against Behring EMIT II and GC/MS showed >98% correlation. Clinical studies at two independent labs demonstrated >97% accuracy for professional users. Consumer study (n=400) demonstrated 97% accuracy (388/400 correct) for lay users.

Technological Characteristics

Lateral flow, visual color, one-step immunoassay. Principle: immunochemical sandwich assay (antibody/target drug complex formation). Form factor: cup. No electronic components or software.

Indications for Use

Indicated for home drug screening of urine for the presence of amphetamine, MDA, methamphetamine, MDMA, THC, cocaine, and opiates. Intended for lay users to assist in drug abuse prevention.

Predicate Devices

• QuickScreen At Home Drug Test (9150T)
• Applied Biotech SureStep Test

Reference Devices

• Behring EMIT II

Submission Summary (Full Text)

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APR 1 4 2003

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

K030447

Identification: At Home Drug Cup (Model 9150X)

Description: Immunoassay for the qualitative detection of amphetamine, MDA methamphetamine, MDMA, THC, cocaine and opiates in urine

| Name Of Manufacturer: | Phamatech<br>9530 Padgett Street, Suite 101<br>San Diego, California 92126, USA |
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Intended Use: The At Home Drug Cup is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentration for this test is as follows: amphetamine and MDA; 1000 ng/ml, methamphetamine and MDMA; 500 ng/ml, THC (or marijuana); 50 ng/ml, cocaine; 300 ng/ml, opiates; 300 ng/ml. This assay is intended for use in the home to assist in the prevention of 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 Cup, like many commercially available drug screening test Technology: kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the QuickScreen At Home Drug Test (9150T) and the Applied 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 / complexes.

Performance: The product performance characteristics of the At Home Drug Cup were evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the Phamatech At Home Drug Cup to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of the stated target drugs in urine. Correlations studies, using clinical specimens. produced a >98% 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 (>97%) in the hands of professional users. A comsumer study was also performed. The At Home Drug Cup exhibited excellent overall accuracy (388/400 correct or 97%) in the hands of lay users.

Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech At Home Drug Cup Model 9150X 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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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three wavy lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES * USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 4 2003

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

Re: k030447 Trade/Device Name: At Home Drug Cup (Model 9150X) Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: MVO; LAF; DKZ; DIO; DJG; LDJ Dated: March 17, 2003 Received: March 24, 2003

## 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 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) 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 general controls provisions of the Act include requirements for annual registration. Iisting 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 that FDA has made 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/dsma/dsmamain.html.

Sincerely vours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety 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 Cup (Model 9150X)

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: Amphetamine, MDA, Methamphetamine, MDMA , THC, Cocaine and Opiates.

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Concurrence of the CDRH Office of Device Evaluation (ODE)

Jean Cooper

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

OR

Prescription Use: Per 21 CFR 801.109 Over the Counter: v