QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178

K993165 · Phamatech · DJG · Oct 20, 1999 · Clinical Toxicology

Device Facts

• Record ID: K993165
• Device Name: QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178
• Applicant: Phamatech
• Product Code: DJG · Clinical Toxicology
• Decision Date: Oct 20, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

QuickScreen Pro Multi Drug Drug Screening Test is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentrations of this test are as follows: methamphetamine; 500 ng/ml, amphetamine; 1000 ng/ml, THC; 50 ng/ml, cocaine; 300 ng/ml, PCP 25 ng/ml and opiates; 2000 ng/ml. This assay is-intended to assist in the prevention of drug abuse

Device Story

QuickScreen Pro Multi Drug Screening Test is a rapid, qualitative, one-step immunoassay for urine drug screening. Input: human urine sample. Principle: immunochemical sandwich assay; specific antibody-target drug-antibody complexes form to produce a visual color change. Output: visual qualitative result indicating presence or absence of target drugs (methamphetamine, amphetamine, THC, cocaine, PCP, opiates) at specified cut-off concentrations. Used in clinical settings by professional users. Healthcare providers interpret visual results to assist in drug abuse diagnosis and treatment decisions. Benefits: rapid, accurate screening for drug metabolites.

Clinical Evidence

Clinical performance evaluated via clinical sample correlation study and blind labeled spiked study. Correlation studies using clinical specimens showed >98% correlation compared to Behring EMIT II and GC/MS methodology. Clinical studies at two independent laboratories demonstrated >97% overall accuracy in professional use.

Technological Characteristics

One-step immunochemical sandwich assay. Qualitative visual colorimetric detection. Target cut-offs: methamphetamine (500 ng/ml), amphetamine (1000 ng/ml), THC (50 ng/ml), cocaine (300 ng/ml), PCP (25 ng/ml), opiates (2000 ng/ml).

Indications for Use

Indicated for professional use as an in vitro diagnostic test for the qualitative identification of amphetamine, cocaine, methamphetamine, opiates, PCP, and THC in human urine to assist in the diagnosis and treatment of drug abuse.

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

• Phamatech QuickScreen At Home DrugTest
• Phamatech QuickScreen Pro Multi Drug ScreeningTest

Reference Devices

• Behring EMIT II

Submission Summary (Full Text)

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OCT 20 1999

## 510 (k) SUMMARY AS REQUIRED BY SECTION 807,92(C)

QuickScreen Pro Multi Drug Screening Test (Model 9177 and 9178) ldentification:

Description: Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine and PCP OR Methamphetamine in urine

Name Of Manufacturer:

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

Intended Use: QuickScreen Pro Multi Drug Drug Screening Test is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentrations of this test are as follows: methamphetamine; 500 ng/ml, amphetamine; 1000 ng/ml, THC; 50 ng/ml, cocaine; 300 ng/ml, PCP 25 ng/ml and opiates; 2000 ng/ml. This assay is-intended to assist in the prevention of drug abuse

The QuickScreen Pro Multi Drug Drug Screening Test, like many commercially Technology: available drug screening test kits, qualitatively measures of target drugs or their metabolites by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the Phamatech QuickScreen At Home DrugTest and the Phamatech QuickScreen Pro Multi Drug ScreeningTest. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug-/-antibodv / complexes.

The product performance characteristics of the QuickScreen Pro Multi Drug Performance: Drug Screening Test were evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the Phamatech QuickScreen Pro Multi Drug Screening 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. Correlation 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.

For the reasons mentioned above, it may be concluded that the Conclusion: Phamatech QuickScreen Pro Multi Drug Drug Screening 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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 20 1999

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

Re: K993165

> Trade Name: QuickScreen Pro Multi Drug Screening Test Regulatory Class: II Product Code: DJG, DKZ, LAF, DIO, LCL, LDJ Dated: September 20, 1999 Received: September 22, 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 (OS) 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 Gutman

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): _K 993/4) S

Device Name: QuickScreen Pro Multi Drug Screening Test (Model 9177 & 9178)

Indications for Use:

An in vitro diagnostic test for the qualitative identification of amphetamine, cocaine, methamphetamine, opiates, PCP and THC in urine. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. It is intended for professional use only.

Lam Corpin

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993165

## PI.F.ASE DO NOT WRITE BELOW THIS LINE

Concurrence of the CDRH Office of Device Evaluation (ODE)

Division Sign-off

Division of Clinical Laboratory Devices

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