AT HOME DRUG TEST, MODEL 9068

K994233 · Phamatech · LAF · Dec 30, 1999 · Clinical Toxicology

Device Facts

• Record ID: K994233
• Device Name: AT HOME DRUG TEST, MODEL 9068
• Applicant: Phamatech
• Product Code: LAF · Clinical Toxicology
• Decision Date: Dec 30, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Intended Use

The At Home Drug Test 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: methamphetamine;(500 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 certified laboratory.

Device Story

At Home Drug Test (Model 9068) is a qualitative, one-step immunoassay for methamphetamine detection in urine. Device utilizes visual color sandwich immunochemical technology; specific antibody-drug-antibody complexes form to indicate presence of target metabolites. Intended for home use by lay individuals; includes mechanism for anonymous confirmation testing at certified laboratories. Results are interpreted visually by the user. Device assists in drug abuse prevention by providing preliminary screening results.

Clinical Evidence

Clinical evidence includes a clinical sample correlation study and a consumer study. Correlation studies using clinical specimens showed >98% correlation with Behring EMIT II and GC/MS. Professional user study (n=not specified) demonstrated >97% overall accuracy. Consumer study (n=4715) demonstrated 96.65% overall accuracy; methamphetamine-specific interpretation accuracy was 96.4% (428/444).

Technological Characteristics

Qualitative one-step visual color sandwich immunoassay. Detects methamphetamine at 500 ng/ml cutoff. Standalone test kit for home use. No electronic components or software.

Indications for Use

Indicated for home drug screening of methamphetamine in urine. Intended for lay users to assist in drug abuse prevention. Includes mechanism for anonymous laboratory confirmation.

Regulatory Classification

Identification

A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

Special Controls

*Classification.* Class II (special controls). A methamphetamine 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

• QuickScreen At Home Drug Test
• Applied Biotech SureStep Test

Reference Devices

• Behring EMIT II

Submission Summary (Full Text)

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DEC 3 0 1999

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

At Home Drug Test (Model 9068) ldentification:

Description: Immunoassay for the qualitative detection of methamphetamine in urine

Name Of Manufacturer:

Phamatech 9265 Activity Road #112 San Diego, California 92126, USA

Intended Use: The At Home Drug Test 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: methamphetamine;(500 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 certified laboratory.

The At Home Drug Test, 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 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 / antibody / complexes.

Performance: The product performance characteristics of the At Home Drug Test 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 Test 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 QuickScreen™ exhibited excellent overall accuracy (>97%) in the hands of professional users. A comsumer study was also performed. The At Home Drug Test exhibited excellent overall accuracy (4557/4715 correct or 96.65%) in the hands of lay users. Consumer interpretation of the methamphetaminetest in this study showed accuracy to be 428/444 or 96.4%.

Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech At Home Drug Test Model 9068 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 3 0 1999

Mr. Carl A. Mongiovi Vice President of Operations Phamatech 9265 Activity Road Suite #112 San Diego, California 92126

Re: K994233 Trade Name: At Home Drug Test (Model 9068) Regulatory Class: II Product Code: LAF Dated: December 14, 1999 Received: December 16, 1999

Dear Mr. Mongiovi:

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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## INDICATIONS FOR USE

Applicant: Phamatech

16994233 510 (k) Number (if known):

Device Name: At Home Drug Test (Model 9068)

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: methamphetamine

Sean Cooper
(Division Sign-Off)

ion of Clinical Laboratory Devices 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: OR Per 21 CFR 801.109

1 Over the Counter:

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