QUIKPAC II ONE STEP OPIATE TEST

{0}------------------------------------------------ K 972405 3 1997 HUJ 510k Submission for QuikPac II One Step Opiate Test Syntron Bioresearch, Inc. Revision A 6/17/97 Printed on 6/24/97 Page 74 of 74 Pages # Summary of Safety and Effectiveness The sponsor, Syntron Bioresearch, Inc. (2774 Loker Ave. West. Carlsbad, California, 92008), has developed, manufactured, and tested under GMP/GLP guidelines a device for the qualitative testing of urine for the presence of Opiate and its metabolites in a screening format. The trade name of the device is QuikPac II One Step Opiate Test having a designated common name of Opiate Test System and a classification as a Class II device per 21 CFR ¶ 862.3250. This device is intended for the medical/forensic screening of urine. Syntron's QuikPac II One Step Opiate Test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 300 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. In-house testing of Syntron's QuikPac II One Step Opiate Test yielded a relative sensitivity or agreement within positive samples of 1.000 and relative specificity or agreement within negative samples of 1.000 and an accuracy of 100% when tested against Syva EMIT® II on samples documented to be positive by GC/MS. A clinical trial consisting of 298 samples was run and the combined data yielded a relative sensitivity of 100%, a relative specificity of 100% with an accuracy of 100% when compared to Emit II®. All positive samples by either screening method were confirmed by GC/MS. There were no false positive or negative results observed in either the in-house clinical trial or the independent clinical trial. Additional information on this submission may be obtained by contacting Dr. Cleve W. Laird, President, Drial Consultants, Inc. at 805-522-6223(Ca) or by fax at 805-522-1526. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Cleve W. Laird, Ph.D. President and CEO Drial Consultants, Inc. 1420 Los Angeles Avenue Suite 201 Simi Valley, CA 93065 K972405 Re : QuikPac II One Step Opiate Assay Regulatory Class: II Product Code: DJG Dated: June 24, 1997 Received: June 26, 1997 Dear Dr. Laird: 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. AUG - 8 1997 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 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/dsmamain.html". Sincerely yours, Steven Ditman 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}------------------------------------------------ ## 510(k) Number (if Known): No Yet Assigned ## Device Name: QuikPac II One Step Opiate Assay ## Indications For Use: Syntron's QuikPac II One Step Opiate assay is a rapid, qualitative, competitive binding immunoassay for the determination of Opiate in urine at the cutoff level of 300 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. Syntron's QuikPac II One Step Opiate Test is not intended to monitor drug levels, but only to screen urines for the presence of Opiate and its metabolites. #### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDOTHER PAGE IF NEEDED) #### Concurance of CDRH, Office of Device Evaluation (ODE) or (Division Sign-Off) Division of Clinical Laboratory igrices: 510(k) Number. K972485 **Perscription Use:** (Per 21 CFR 801.109 Over The Counter Use: Optional Format 1-2-96}