QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065)

K972556 · Phamatech · LAF · Sep 2, 1997 · Clinical Toxicology

Device Facts

• Record ID: K972556
• Device Name: QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065)
• Applicant: Phamatech
• Product Code: LAF · Clinical Toxicology
• Decision Date: Sep 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Intended Use

A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of methamphetamine, a central nervous system stimulating drug, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

Device Story

QuickScreen™ One Step Methamphetamine Test is a lateral flow immunoassay for qualitative detection of methamphetamine in urine. Device utilizes colloidal gold-labeled antibodies in a sandwich immunoassay format; visual color change indicates presence of methamphetamine. Used in clinical toxicology labs, physicians' offices, clinics, and law enforcement agencies by professional technicians. Provides rapid qualitative results to assist healthcare providers in diagnosis and treatment of methamphetamine use or overdose.

Clinical Evidence

Clinical performance evaluated via sample correlation and blind labeled studies. Compared to Syva EMIT II, device demonstrated >95% sensitivity, >99% specificity, and >97% accuracy. Additional laboratory study showed 84/86 sensitivity, 39/39 specificity, and 123/125 accuracy.

Technological Characteristics

Lateral flow immunoassay; colloidal gold label; visual colorimetric readout; sandwich immunoassay principle (antibody/methamphetamine/antibody complex formation).

Indications for Use

Indicated for the qualitative detection of methamphetamine in urine for individuals suspected of methamphetamine use or overdose. Intended for use in clinical toxicology labs, physicians' offices, drug-of-abuse clinics, and law enforcement agencies.

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

• ABI SureStep
• Syntron Bioresearch Methamphetamine Test

Reference Devices

• Syva EMIT II

Submission Summary (Full Text)

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SEP - 2 1997

10972556

## 510(k) SUMMARY As Required By Section 807.92(c)

## QuickScreen™ One Step Methamphetamine Test

Immunoassay for the Qualitative Detection of Methamphetamine in Urine

| Name of Product: | QuickScreen™ One Step Methamphetamine Test |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name Of Packager: | Phamatech<br>9265 Activity Road #112<br>San Diego, California 92126<br>USA |
| Name Of Manufacturer: | Phamatech<br>9520 Padgett Street #108<br>San Diego, California 92126<br>USA |
| Site of Control Testing: | Phamatech<br>9265 Activity Road #112<br>San Diego, California 92126<br>USA |
| Sites of Clinical Testing: | Poison Laboratories<br>7272 Clairemont Mesa Blvd.<br>San Diego, CA 92111<br>Quest Diagnostics Incorporated<br>7470 Mission Valley Road<br>San Diego, CA 92108 |

Regulatory Control Number: 011

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

Identification: OuickScreen TM One Step Methamphetamine Screening Test (9065)

Description: Immunoassay for the Qualitative Detection of Methamphetamine in Urine

Name Of Manufacturer:

Phamatech 9265 Activity Road #112 / 113 San Diego, California 92126, USA

Intended Use: A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of methamphetamine, a central nervous system stimulating drug, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose

The QuickScreenTM One Step Methamphetamine Test utilizes colloidal Technology: gold as the label like other commercially available immunoassays for drug of abuse (methamphetamine) test kits, to qualitatively measure the presence of methamphetamine by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the ABI SureStep (San Diego. CA 92121)and the Syntron Bioresearch Methamphetamine Test (Vista, CA 92083). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / Methamphetamine / antibody / complexes.

Performance: The product performance characteristics of the QuickScreen™ One Step Methamphetamine Test was evaluated in a clinical sample correlation study and a blind labeled methamphetamine study. The results of these studies demonstrate the Phamatech QuickScreen™ One Step Methamphetamine Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of methamphetamine in urine. Correlation studies, using clinical specimens, produced a sensitivity of >95%, specificity of >99% and accuracy >97% when compared to the Syva EMIT II (San Jose, CA 95161). Two clinical laboratory studies were performed, the Phamatech QuickScreen™ exhibited excellent sensitivity (84/86), specificity (39/39), and accuracy (123/125) in the hands of professional laboratory technicians.

Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech QuickScreen™ One Step Methamphetamine ScreeningTest is substantially equivalent to a variety of qualitative methamphetamine tests currently in commercial distribution.

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SEP - 2 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Tuan H. Pham President Phamatech, Inc. 9265 Activity Road, Suite 112-113 San Diego, California 92126

K972556 Re: QuickScreen™ One Step Methamphetamine Test Requlatory Class: II Product Code: LAF Dated: July 7, 1997 Received: July 9, 1997

Dear Tuan H. Pham:

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 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 In addition, FDA may publish further announcements action. 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 requlations.

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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 requlation (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/dsmamain.html".

Sincerely yours,
Steven Litman

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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Fax:[phone]

## INDICATIONS FOR USE

Applicant: Phamatech

510(k) Number (if known): 972556

Device Name. QuickScreen TM One Step Methamphetamine Test

Indications for Use:

A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of methamphetamine, a central nervous system stimulating drug, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

PLEASE DO NOT WRITE BELOW THIS LINE

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Denicas,
510(k) Number. 56

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

| Prescription Use: | <div><img alt="Checkmark" src="checkmark.png"/></div> |
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| Per 21 CFR 801.109 | |

Over the Counter OR