QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C

{0}------------------------------------------------ OCT 6 1999 ### 510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C) QuickScreen Workplace Drug Screening Test (Model 9147 25C) ldentification: Description: Immunoassay for the qualitative detection Methamphetamine. THC. Cocaine and Opiates in urine ### Name Of Manufacturer: Phamatech 9265 Activity Road #112 San Diego, California 92126, USA Intended Use: QuickScreen Workplace 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. cocaine: 300 ng/ml and opiates; 300 ng/ml. This assay is intended for use in the workplace assist in the prevention of drug abuse. This kit, as supplied, incorporates a mechanism for confirmation testing by GC/MS, to be performed at a certified laboratory. The QuickScreen Workplace Drug Screening Test, like many commercially available Technology: drug screening test 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 Phamatech QuickScreen At Home Drug Test 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 / antibody / complexes. The product performance characteristics of the QuickScreen Workplace Drug Performance: 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 Workplace 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. 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 using the At Home Drug Test, which utilizes identical formulation and, like the QuickScreen Workplace Drug Screening Test, includes GC/MS confirmation testing as a component, was performed. In the hands of lay users the test exhibited excellent overall accuracy (>96.4%). For the reasons mentioned above, it may be concluded that the Conclusion: Phamatech QuickScreen Workplace 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. {1}------------------------------------------------ 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 a human figure with three wavy lines extending from the figure's head, resembling a bird in flight. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 OCT 6 1999 Mr. Carl A. Mongiovi Vice President of Operations Phamatech 9265 Activity Road Suite #112 San Diego, California 92126 Re: K992685 > Trade Name: QuickScreen Pro Multi Drug Screening Test (Model 9147) Regulatory Class: II Product Code: LAF, DKZ, LDJ, DIO, DJG Dated: September 13, 1999 Received: September 13, 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. {2}------------------------------------------------ ### Page 2 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 (770) 488-7655. 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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 {3}------------------------------------------------ # INDICATIONS FOR USE Applicant: Phamatech 510 (k) Number (if known): _K 9 92(g85 Device Name: QuickScreen Workplace Drug Screening Test (Model 9147 25C) Indications for Use: A workplace 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, Amphetamine, THC, Cocaine and Opiates P.Bernlavet for g.Cooper DVM (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number IS 997685 # 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 Over the Counter: OR