QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)

{0}------------------------------------------------ K472014 AUG 20 .. ### 510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C) QuickScreen TM One Step Opiate Screening Test (9080) ldentification: Immunoassay for the Qualitative Detection of Opiates in Urine Description: 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 any addictive narcotic pain relieving opiate drugs, in urine. An opiate is any natural or synthetic drug that has morphine-like pharmacological actions. Measurements that are obtained by this device are used in the diagnosis and treatment of Opiates use or overdose The QuickScreenTM One Step Opiates Test utilizes colloidal gold as the Technology: label like other commercially available immunoassays for drug of abuse (Opiates) test kits, to qualitatively measure the presence of opiates 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 Opiates Test (Vista, CA 92083). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / Opiates / antibody / complexes. Performance: The product performance characteristics of the QuickScreenTM One Step Opiates Test was evaluated in a clinical sample correlation study and a blind labeled Opiates study. The results of these studies demonstrate the Phamatech QuickScreenTM One Step Opiates Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of Opiates 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 (116/116), specificity (35/35), and accuracy (151/151) versus the EMIT II immunoassay in the hands of professional laboratory technicians. Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech QuickScreen™ One Step Opiates ScreeningTest is substantially equivalent to a variety of qualitative Opiates tests currently in commercial distribution. {1}------------------------------------------------ # 510(k) SUMMARY As Required By Section 807.92(c) # QuickScreen™ Opiate Screening Test Immunoassay for the Qualitative Detection of Opiate and its metabolites in Urine | Name of Product: | QuickScreen™ One Step Opiate Screening Test | |----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name Of Packager: | Phamatech<br>9265 Activity Road #112<br>San Diego, California 92126<br>USA | | Name Of Manufacturer: | Phamatech<br>9265 Activity Road #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><br>Quest Diagnostics Incorporated<br>7470 Mission Valley Road<br>San Diego, CA 92108 | Regulatory Control Number: 012 {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Mr. Carl A. Mongiovi Director of Operations Phamatech 9265 Activity Roads Suite 112-113 AUG 20 1997 San Diego, California 92126 · Re: K972619 QuickScreen™ One Step Opiate Screening Test Trade Name: Product Code: DJG Requlatory Class: II DJJ II Dated: July 8, 1997 Received: July 11, 1997 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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requiation (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 requlatory 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. {3}------------------------------------------------ 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 requlation 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" Sincerely yours, Steven Putman 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 {4}------------------------------------------------ #### INDICATIONS FOR USE Applicant: Phamatech 510(k) Number (if known): K972619 Device Name: QuickScreen TM One Step Opiate Screening 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 any addictive narcotic pain relieving opiate drug, in urine. An opiate is any natural or synthetic drug that has morphine-like pharmaco-logical actions. The opiates include drugs such as morphine, heroin, codeine, nalorphine,meperidine and morphine glucuronide. Measurements that are 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. PLEASE DO NOT WRITE BELOW THIS LINE Concurrence of CDRH Office of Device Evaluation (ODE) hronica J. Calvin for 4. Montgomery (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K972619 Division Sign-Off Division of Clinical Laboratory Devices 510(k) Number: Prescription Use: OR Over the Counter